Recommended for Practice

Cognitive Behavioral Interventions/Approach

for Caregiver Strain and Burden

Cognitive behavioral interventions are designed to reflect concepts from cognitive behavioral therapy, which examine the associations among thoughts, feelings, and behaviors. Cognitive behavioral interventions do not involve full cognitive behavioral psychotherapy; however, they do assist patients in identifying negative or unhelpful thoughts and beliefs so they can be altered. Cognitive behavioral intervention approaches also help individuals to identify helpful and unhelpful behaviors, establish goals, and develop skills to solve problems and implement new behaviors to facilitate effective coping. Structured programs based on cognitive behavioral approaches may include activities such as education or relaxation training, may be provided in individual or group settings, and may be delivered in person, by telephone, or by other methods.

Systematic Review/Meta-Analysis

Chi, N., Demiris, G., Lewis, F.M., Walker, A.J., & Langer, S.L. (2016). Behavioral and educational interventions to support family caregivers in end-of-life care. American Journal of Hospice and Palliative Medicine, 33, 894–908. 

Purpose

STUDY PURPOSE: To collect, review, and report on the current evidence on behavioral and educational interventions used to support family caregivers of patients who are receiving end-of-life care

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, CINAHL, Embase, Cochrane Library
 
INCLUSION CRITERIA: Phase II or phase III clinical trials published in English, looking at behavioral and educational interventions to support family caregivers at end-of-life care; published from 2004–2014
 
EXCLUSION CRITERIA: Peer review required, not caregiver focused, not family caregivers of adults receiving end-of-life care

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,649, 618 were in English
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The Oxford Center for Evidence-Based Medicine framework was used to evaluate the findings.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 14 
  • TOTAL PATIENTS INCLUDED IN REVIEW: 1,773 total—406 in educational interventions, 1,152 in cognitive behavioral therapy interventions, and 575 in psychoeducational interventions
  • SAMPLE RANGE ACROSS STUDIES: Three studies had a sample of 10–50, two had 50–100, five had more than 100, two had more than 200, one hand more than 300, and one had more than 400.
  • KEY SAMPLE CHARACTERISTICS: All studies were phase 2 or 3 studies. Eight of 14 studies included caregivers of patients with advanced cancer; mean age of 55–61 years; high percentage of females (70% in 10 studies), Caucasians (60%–80% in seven studies), and spouses/partners (60%–70% in six studies)

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care
 
APPLICATIONS: Palliative care

Results

Fourteen studies were identified, eight of which involved patients with cancer, supporting the use of educational, psycho-educational, and cognitive behavioral interventions to support caregivers in end-of-life care. Cognitive behavioral therapy had the strongest evidence and impact on most outcomes, with six intervention studies reported on, five studying patients with advanced cancer, and four of which were randomized, controlled trials (three with samples more than 100). Outcomes included statistically significant improvement and increased self-efficacy, quality of life, hope, psychological health, and problem solving. Four psycho-educational intervention studies existed, all involving patients with advanced cancer. Two were large randomized, controlled trials, with samples of 100. Caregivers showed increased preparedness, competence, knowledge, improved psychological health, increased positive rewards, less unmet needs, and increased social support. The four educational interventions studied included two smaller studies and, although studying care of patients at the end of life, none of them were specific to patients with cancer, although some included patients with advanced cancer. One of the larger studies (n = 110) was of caregivers of patients with dementia. The interventions in these studies showed improvement in caregiver preparedness, knowledge, support, confidence, helpful beliefs, and satisfaction with care.

Conclusions

Educational and behavioral interventions for caregivers of patients with advanced cancer at the end of life appear to be effective. They are difficult to study because of high attrition rates, in part because of the point in the illness trajectory in which one is asked to participate. However, increasing evidence supports that these types of interventions will benefit caregiver competence and well-being. Ongoing study is needed to identify more specifics about the interventions, what makes them successful, and the methods of delivery, the timing, and the dose, as well as what outcomes should be measured and with what instruments. Perhaps some consistency should be developed. The cost-effectiveness of interventions should be considered as well.

Limitations

  • High heterogeneity
  • High attrition rates
  • About half were smaller studies of quasiexperimental design, and the types of interventions studied were clearly different and should be looked at individually.

Nursing Implications

Educational and behavioral interventions for caregivers appear to be helpful in improving caregiver outcomes, with statistical improvement seen in a variety of caregiver domains. The type of intervention strategy used seems to influence the specificity and breadth of outcomes influenced, with some showing more results on competence and knowledge and others expanding beyond competence and knowledge to include an additional impact on the emotional well-being and quality of life of the caregiver. All three types of interventions appear to have positive impact. Care must be taken when choosing an intervention, considering what outcome is desire.

Print

Langford, D. J., Lee, K., & Miaskowski, C. (2012). Sleep disturbance interventions in oncology patients and family caregivers: a comprehensive review and meta-analysis. Sleep Medicine Reviews, 16, 397–414.

Purpose

To synthesize findings from intervention studies for sleep disturbance in patients with cancer and their caregivers.

Search Strategy

Databases searched were PubMed, CINAHL, and PsycINFO.

Search keywords were sleep, sleep disturbance, insomnia, intervention, cancer, oncology, and caregivers.

Studies dated through 2010 that evaluated sleep disturbance/sleep quality as the primary or secondary outcome were included.

Literature Evaluated

  • The total number of references retrieved was not stated.
  • The method of study evaluation was described for the type of intervention, mode of delivery, dose, and duration but not for study quality.
  • There were only two studies that affected caregivers.

Sample Characteristics

  • The final number of studies included was 49 (47 targeting patients and 2 targeting caregivers). 
  • Thirteen studies were included in the meta-analysis (total of 1,202 patients with cancer). 
  • The total sample across all studies was 3,205 patients.
  • The sample range across studies was 9 to 276 patients (including patients with cancer).
  • Patients had various cancer types, phases of treatment, and stages of disease. 
  • Women with breast cancer were studied most commonly.

Results

Intervention groupings analyzed via meta-analysis included cognitive-behavioral therapy (CBT), education, exercise, and complementary and alternative therapies. Effect sizes appeared to be slightly over 1.0 for CBT, close to 0 for education, slightly over 1.0 for exercise, and slightly over 0 for complementary and alternative therapies. Specific effect sizes were only shown graphically, and actual data were not presented. No separate analysis of caregiver effects could be determined. Modes of delivery of interventions varied widely across studies.

Conclusions

Findings suggest at least moderate effects of CBT and exercise for improvement in sleep disturbances for patients with cancer. No substantial effects of exercise and education were demonstrated.

Limitations

The review was limited by the lack of any data regarding heterogeneity in the meta-analysis, variability of interventions, and modes of delivery to enable any firm conclusions.

Nursing Implications

Insufficient evidence was provided to draw any conclusions regarding intervention effects for caregivers.

Print

Northouse, L.L., Katapodi, M.C., Song, L., Zhang, L., & Mood, D.W. (2010). Interventions with family caregivers of cancer patients: Meta-analysis of randomized trials. CA: A Cancer Journal for Clinicians, 60, 317–339.

Purpose

To provide a meta-analysis that examines interventions delivered to family caregivers of patients with cancer in published randomized controlled trials and their effects on multiple caregiver outcomes

Search Strategy

  • Databases used in the search were CINAHL, Google Scholar, ISI Web of Knowledge, PsycINFO, and PubMed.
  • Keywords were family caregiver, cancer patient, spouse, partner, couple, and interventions used in various combinations. In cases where the query resulted in more than 200 titles, additional refinement was done with use of “random assignment” and “randomization.”
  • Hand searches of reference lists of related literature reviews were used to complement computer searches. Limits of English language and involving human subjects were used.
  • To be included, (a) the intervention had to involve family caregivers alone or with a patient with cancer, (b) the intervention had to be psychosocially, cognitively, or behaviorally oriented, and (c) participants had to be randomly assigned to either an intervention or control arm of the study.
  • Studies involving pediatric patients with cancer and pharmacologic interventions were excluded.

Literature Evaluated

  • Initial queries provided 403 articles, in which 160 were potentially relevant. Of these, 124 were excluded as per criteria and 7 were excluded because caregiver outcome data were not reported.
  • At least two members of the research team read and analyzed each article. Data were extracted using a standard table, and disagreements were resolved through consensus. Data extracted were organized into three domains: illness appraisal factors, coping resources, and quality of life (QOL).
  • Effect sizes were calculated using outcome data from the experimental arm hypothesized by the original researchers to be most effective, in those studies that had more than one experimental arm.
  • Extracted data were organized into three time frames: baseline to three months postintervention (T1), follow-up from > three months to six months (T2), and follow-up beyond six months (T3).

Sample Characteristics

The final sample of studies used in the meta-analysis was 29, including a total of 3,495 subjects across all studies.

Results

Intervention Types

  • 57.1% of interventions were psychoeducational in which the primary focus was to provide information regarding symptom management and physical aspects of care, as well as to direct some attention to emotional and psychosocial needs of patients, caregivers, and marital and family relationship.
  • 25.7% of protocols were focused on skills training: development of coping, communication, and problem-solving skills.
  • 17.1% of interventions were therapeutic counseling, focusing primarily on development of a therapeutic relationship to address concerns.
  • The most common combination of primary and secondary interventions included both psychoeducational and skills training (68.6%).

Appraisal Domain Results

  • Eleven studies assessed caregiving burden during the first three months. Effect sizes ranged from -0.12 to 0.62, with a small but significant effect size (g = 0.22).
  • In two studies, interventions had a positive significant effect on appraisal of caregiving benefit between three and six months (g = 0.31). Beyond six months, this appraisal showed a larger effect size, but was not significant. (Caregiving benefit was seen as a rewarding experience and opportunity for personal growth.)
  • Three studies looked at whether the intervention was effective in addressing caregivers’ information needs. Overall effect size was large and significant (g = 1.36, range = 0.85–1.87).

Coping Resources Domain

  • Coping efforts were evaluated during the first three months in 10 studies. After the intervention, overall effect size was moderate but significant (g = 0.47, range = -0.47–1.46).
  • In four studies, changes in coping efforts three to six months postintervention showed a smaller but significant effect size (g = 0.20).
  • Two studies evaluated coping efforts beyond six months. There was a persistent moderate effect that was significant (g = 0.35).
  • In eight studies that evaluated self-efficacy within three months postintervention, overall effect size was small but significant (g = 0.25, range =  -0.13–0.93). This positive significant effect persisted over time.

Quality of Life Domain

  • In seven studies that evaluated physical functioning, during the first three months overall effect size was small and not significant. However, interventions were superior to usual care in improving physical functions at three to six months (g = 0.22) and beyond six months (g = 0.26).
  • Interventions were seen to be superior to usual care in reducing distress and anxiety, and the effect appeared to last for at least 12 months. Sixteen studies evaluated changes in mental distress and anxiety during the first three months, 11 evaluated these changes at three to six months, and 6 evaluated distress and anxiety beyond six months.
  • Interventions were not successful in reducing caregivers’ depression. In all of the studies that evaluated these changes at various time points, overall effects were small and not significant.
  • Among 10 studies that evaluated changes in marital and family relationships in the first three months, overall effect size was small but significant (g = 0.20, range = -0.18–0.47). Evaluation beyond three months did not show significant effects.
  • Effects on social functions in two studies that were evaluated beyond six months showed an overall positive moderate effect that was significant (g = 0.39). There were no other significant effects seen in other studies that evaluated changes in social functioning.

Effect of Intervention Characteristics

  • Coping was found to be significantly influenced by the use of face-to-face and group methods of intervention delivery than those using mixed methods to deliver the intervention.
  • Intervention hours and number of sessions were significantly positively correlated with coping outcomes.
  • More sessions were associated with more negative (worse) outcomes in the case of caregiver burden, depression, and marital-family relations.
  • Interventions that included caregivers alone reported significantly better outcomes in appraisal of caregiving benefit than interventions that also included patients.

Conclusions

Nurses participated in delivery of the intervention in about half of the studies examined. Interventions focused on three broad areas: patient caregiving, marital/family care, and caregiver care, although there was considerable variability in the emphasis of each area in all studies and many interventions focused mostly on the patient, with a peripheral addressing of caregiver needs. The meta-analysis noted there is a consensus that these are essential content for caregiver-focused intervention protocols. Many of the 29 studies used theoretical models to structure their protocols and had plans to assess integrity of the interventions. Interventions were found to not be effective in decreasing caregiver depression, perhaps a result of the type of cancer or high predominance of females in the 29 studies. On the other hand, interventions aimed at improving caregiver coping were more effective, particularly if the intervention included more sessions and lasted a longer time. Coping outcomes improved more often with face-to-face or group-delivered interventions and if the focus was on promoting active caregiver coping and reducing avoidance and denial behaviors. Although the meta-analysis showed a large intervention effect with decreasing caregivers’ need for knowledge (and most studies had a significant educational component), few studies measured caregiver change in knowledge as an outcome.

Nursing Implications

This meta-analysis of 29 studies, with variant use of theoretical models, offers insight into effective interventions that improve the life of cancer caregivers and those for whom they care for. Despite the diversity in interventions found in the studies, caregivers reported better outcomes in illness appraisal, coping resources, and quality of life following research study involvement. Positive and long-term intervention effects occurred for caregiver coping, self-efficacy, and distress/anxiety outcomes across all studies. Continued emphasis must be placed on weaving theoretical models throughout studies to generate hypotheses, select components of intervention to ensure integrity, and identify outcomes.

Print

O'Toole, M.S., Zachariae, R., Renna, M.E., Mennin, D.S., & Applebaum, A. (2016). Cognitive behavioral therapies for informal caregivers of patients with cancer and cancer survivors: A systematic review and meta-analysis. Psycho-Oncology. Advance online publication. 

Purpose

STUDY PURPOSE: To evaluate the overall effect of interventions using cognitive behavioral therapy (CBT) components and to explore possible moderators of this effect, including trial design, outcomes evaluated, demographic variables, intervention duration and modality of delivery, illness-related variables among patients, and study quality

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PsycINFO, Cochrane, CINAHL, and Embase
 
INCLUSION CRITERIA: Peer-reviewed articles and articles that (a) investigated the effect of a CBT for informal caregivers (ICs) of patients with cancer or cancer survivors; (b) employed at least one quantitative measure of psychological, physical, or interpersonal functioning/well-being of the IC both pre- and postintervention; (c) enrolled adult samples aged 18 years or older; (d) reported results that could be converted into an effect size; and (e) were written in English. Articles about CBT if it included at least one of the following components: cognitive restructuring, imaginal or in vivo exposure, coping skills training, problem solving, behavior activation, behavioral experiments, structured homework, acceptance-based strategies, stress and anxiety management through relaxation, or mindfulness
 
EXCLUSION CRITERIA: Nonadult, non-English, after January 2014

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,131 retrieved, 163 eligible 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 36
  • TOTAL PATIENTS INCLUDED IN REVIEW = 3,820 analyzed
  • KEY SAMPLE CHARACTERISTICS: Randomized, controlled trials (RCTs) (K = 27) comparing CBTs with a nonactive control condition (K = 21). Individual (as opposed to group) (K = 28) therapy for couples/dyads (K = 28), and delivered face-to-face (K = 22). Patients with mixed stages of cancer (K = 14). Twelve studies explicitly stated that the intervention adhered to a cognitive behavioral framework. The most commonly employed treatment components (see definition above) were coping skills training (K = 24), problem solving (K = 15), cognitive restructuring (K = 14), structured homework (K =11), and relaxation (K = 10).

Results

A small statistically significant effect of CBTs (Hedges' g = 0.08, p = 0.014) was revealed, which disappeared when RCTs were evaluated alone (Hedges' g = 0.04, p = 0.2). A number of variables were explored as moderators. Only the percentage of female participants was positively associated with the effect size. More specifically, females were more responsive to CBT interventions with an effect on physical health and mastery.

Conclusions

Based on the negligible effect of CBTs across outcomes, future studies should consider moving beyond traditional CBT methods, as these do not appear efficacious. Future interventions should orient toward advances in the basic affective sciences and derived therapies to better understand and treat the emotional struggles experienced by ICs.

Limitations

  • High heterogeneity
  • Low sample sizes
  • Variability in theoretical definition and use of CBT across studies

Nursing Implications

Translating CBT interventions to practice has been a challenge in the nursing discipline. These findings suggest that, although CBT techniques like problem solving could be meaningful, CBT may be one component of a mulitmodual intervention for the best effect for the family caregiver. Nurses should also recognize that gender may influence the possible benefit patients experience from a CBT intervention.

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Research Evidence Summaries

Bevans, M., Castro, K., Prince, P., Shelburne, N., Prachenko, O., Loscalzo, M., . . . Zabora, J. (2010). An individualized dyadic problem-solving education intervention for patients and family caregivers during allogeneic hematopoietic stem cell transplantation: A feasibility study. Cancer Nursing, 33(2), e24–e32.

Study Purpose

To evaluate the feasibility of providing an individualized problem-solving education intervention to patient-caregiver dyads during stem cell transplantation

Intervention Characteristics/Basic Study Process

The intervention was based on the COPE model involving creativity, optimism, planning, and expert information. Sessions used an active problem identified by each dyad to apply the COPE problem solving model. The clinician interventionist guided the dyad in problem identification, review of related expert information, and development of a plan to address the problem. Scripting, peer supervision, and session audiotapes were used to ensure integrity of the intervention. Data were collected with a log and subject interviews. Audiotaped interviews were transcribed for analysis, and a second transcriber did quality monitoring on 100% of the tapes to ensure accuracy and completeness. Four sessions were provided—prior to transplantation, at the time of hospital discharge, two weeks after discharge, and four weeks after discharge. Dyads also attended usual admission and discharge education classes provided as part of usual care. Data collection occurred at baseline, each of these time points, and six weeks after initial hospital discharge.

Sample Characteristics

  • The sample included eight dyads (patient and spouse pairs).
  • The mean age of patients was 56.5 ± 7.9, and the mean age of caregivers was 53.9 ± 9.67.
  • Females made up 25% of patients and 62.5% of caregivers.
  • Males made up 75% of patients and 37.5% of caregivers.
  • Non-Hodgkin Lymphoma was the most prevalent cancer type.
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 37.5%, 1 in 50%, and 2 in 12.5%.
  • Initial hospitalization for transplantation was a median of 14.5 days (range 11–29).
  • 63% required hospital readmission during the study period.
  • Overall, subjects and caregivers reported levels of symptom distress suggesting a low symptom burden.
  • All caregivers were the patients' spouses.
  • The study period was the acute episode of care.

Setting

  • Single site
  • Inpatient and outpatient setting
  • Transplant unit in Maryland
  • Large research center

Study Design

A single group repeated measures mixed method design was used.

Measurement Instruments/Methods

  • Brief Symptom Inventory (BSI)
  • Social Problem-Solving Inventory (SPSI-R)
  • Family Adaptability and Cohesion Evaluation Scale (FACES-IV)
  • Symptom Distress Scale (SDS)

Results

Ninety-four percent of scheduled sessions were completed. Session length was a median of 45 minutes, ranging from 15–60 minutes. Clinicians reported session scheduling as the greatest challenge.

Themes that emerged from qualitative analysis were “opportunity to talk,” “expert information,” and “creative thinking.” Effect sizes for each measure for patients and caregivers over time were reported. Subjects’ SPSI-R scores were within normative group range, suggesting effective problem solving ability prior to the intervention. Patient baseline distress was significantly related to a change in SPSI-R scores over the course of the study (r = 0.8, p = 0.031). It was noted that the caregiving experience was not limited to a spouse, and the study experience pointed to the need to expand the network to all those involved. Effect sizes of change in measures were provided, but there were no differences in outcomes over time.

Conclusions

Provision of this type of intervention appears to be feasible, and although scheduling sessions was shown to be challenging to clinicians, a high proportion of sessions were completed. The study provides some initial effect size data in the outcome variables measured. Authors identified the need to include a broader network of caregivers and further explore alternative timing and scheduling approaches for this type of intervention.

Limitations

  • The sample had less than 30 participants. This was a small feasibility study, and although some effect size data was gained, the sample was very small.
  • The sample was a fairly homogenous ethnic group.
  • A study goal was to determine feasibility, but there was no control or comparison group.
  • The full study period was a relatively short period of time, encompassing mainly the acute episode of care.

Nursing Implications

Findings suggest that provision of individualized counseling and problem solving sessions using the COPE model is feasible with patients who have undergone stem cell transplant. In provision of caregiver support, nurses need to consider involving a number of caregivers because the network of individuals who are involved is often beyond a dyad. A broader involvement may also be helpful in dealing with session scheduling difficulties because of competing spouse priorities. Further research is warranted to evaluate effect sizes, different dosage, and timing of such interventions and involving various cultural groups. Further research including control groups is warranted as other similar studies have shown improvement in various patient and caregiver measures as a function of time alone.

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Boele, F.W., Hoeben, W., Hilverda, K., Lenting, J., Calis, A.L., Sizoo, E.M., . . . Klein, M. (2013). Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: A randomized controlled trial. Journal of Neuro-Oncology, 111, 303–311.

Study Purpose

To determine factors that impact health-related quality of life (HRQOL) and mastery of caregivers of patients with high-grade glioma, and to investigate if a structured intervention consisting of psycho-education and cognitive behavioral therapy (CBT) leads to an improvement in the mental component of HRQOL and mastery of caregivers

Intervention Characteristics/Basic Study Process

Caregiver dyads randomly were assigned to the intervention group or care as usual group. The intervention group consisted of six one-hour sessions with a psychologist for CBT and psycho-education regarding disease-specific symptoms. Participants completed questionnaires concerning their perception of the patients' HRQOL, neurologic functioning, cognitive functioning, their own HRQOL perceptions, and feelings of caregiver mastery at baseline (prior to randomization) and every two months thereafter until eight months later, five times total.

Sample Characteristics

  • N = 56 caregiver dyads  
  • MEAN AGE = 50 years
  • MALES: Intervention group = 26%, control group = 48%; FEMALES: Intervention group = 74%, control group = 52%
  • KEY DISEASE CHARACTERISTICS: High-grade glioma stage III/IV
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants were informal caregivers (defined as a spouse or significant other providing at least 21 hours of care per week); aged 18 years or older; 57% were receiving active treatment during the study 

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient  
  •  LOCATION: VU University Medical Center (Amsterdam)/Academic Medical Center (Amsterdam), and Medical Center Haaglanden (Netherlands)

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • MOS 36-item short form survey (SF-36)
  • Caregiver mastery scale
  • MOS Cognitive Functioning Scale
  • Brain cancer module

Results

Caregivers' HRQOL and caregiver mastery were associated with patient-related factors at baseline. A positive correlation was found between a positive mental functioning (MCS) of the patient and a positive MCS of the caregiver. Feelings of mastery in the intervention group increased over time, while feelings of mastery in the control group showed the opposite pattern. Those who received the intervention maintained a more stable level of mental functioning and showed modest improvement in feelings of mastery in comparison to the control group. Patients' HRQOL and neurologic functioning were found to be related to HRQOL and feelings of mastery of the informal caregiver at baseline. The intervention helped caregivers in maintaining a stable level of HRQOL and improved feelings of mastery over an eight-month period.

Conclusions

The findings from this RCT suggest that informal caregivers can benefit from a psychological CBT intervention because it is a helpful tool in maintaining a stable level of mental functioning and caregiver mastery.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable as a result of high attrition
  • Intervention expensive, impractical, or training needs—significant time/burden for the caregiver (burdensome)
  • Subject withdrawals 10% or greater
  • Other limitations/explanation: Approximately 24% died prior to study conclusion

Nursing Implications

Future nursing practice should focus on offering supportive interventions to patients with high-grade glioma and their informal caregivers. Further research should continue to look at the effects of a psychological intervention on HRQOL and feelings of mastery of informal caregivers of the high-grade glioma patient population. Findings suggest that CBT interventions can be of benefit to caregivers.

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Campbell, L.C., Keefe, F.J., Scipio, C., McKee, D.C., Edwards, C.L., Herman, S.H., . . . Donatucci, C. (2007). Facilitating research participation and improving quality of life for African American prostate cancer survivors and their intimate partners. A pilot study of telephone-based coping skills training. Cancer, 109(Suppl. 2), 414–424.

Study Purpose

To examine the feasibility and effect of a telephonic cognitive behavioral intervention to facilitate research participation and enhance quality of life among African American prostate cancer survivors and their partners

Intervention Characteristics/Basic Study Process

Consenting patients and their partners provided pretreatment measures and then were randomly assigned to either partner-assisted coping skills training (CST) or usual care (control condition). In the control group, individuals received routine care provided through their medical outpatient program. The CST intervention was designed to train survivors and partners in skills for managing symptoms, including provision of information about prostate cancer and possible long-term side effects, teaching problem solving skills and training in cognitive and behavioral coping skills such as communication, relaxation, and activity pacing. CST was provided in six one-hour telephone calls approximately once a week. Sessions were audiotaped and reviewed for protocol adherence. All subjects completed post-treatment study measures at the end of the six-week period.

Sample Characteristics

  • The sample included 30 patient participants and 30 spouse participants.
  • The mean age was 62.1 ± 8.9 for patients and 58.7 ± 9.8 for partners.
  • Females: Partner gender was not stated, so it is assumed that all partners were female (n = 30).
  • Males: All patients were male (n = 30).
  • All patients had prostate cancer.
  • Time since treatment ranged from 1 week to 4 years, with an average of 18 months.
  • 86% of patients and 93% of partners had completed at least a high school education, 53% of survivors were working full-time, and 37% were retired.
  • Among partners, 46% were working full-time, and 46% were retired.
  • Annual income was $30,000 or greater in 67% of the sample.

Setting

  • Multi-site
  • Outpatient setting
  • Multiple practices and clinics in North Carolina

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Self-Efficacy for Symptom Control Efficacy (SESCI) patient and partner versions
  • Expanded Prostate Cancer Index Composite (EPIC)
  • Short Form 36 (SF-36) physical function and mental health scales
  • Profile of Mood States Short Form (POMS - SF)
  • Caregiver Strain Index (CSI)

Results

Seven couples initially randomized to the treatment group withdrew (approximately 30%) primarily because of difficulties in scheduling treatment sessions.

Men who participated in the CST reported significantly higher quality of life related to bowel symptoms (p = 0.042). There were no significant differences between groups in general health, negative mood among partners, caregiver strain, or caregiver self-efficacy. Within the CST group, pre-post treatment measurement demonstrated significant improvement in reported bowel symptoms (p < 0.05), hormonal symptoms (p < 0.05) and self-efficacy (p < 0.05). There were no significant differences between pre and post-treatment measures among the partners (no effect on caregivers).

Conclusions

The telephone intervention was able to be delivered to the majority of participants, suggesting that this approach may be feasible for the delivery of coping skills training. Significant effects to improve caregiver self-efficacy and experience were not seen. This type of intervention appears to be helpful to patients in the area of managing side effects of prostate cancer.

Limitations

  • The sample had less than 30 participants.
  • Eligible patients had good performance scores for inclusion, and the majority were working full-time. This suggests that the sample was relatively healthy and caregiving needs may have been low. This may have influenced the lack of significant findings among intimate partners related to the intervention.
  • There is no information about what was included in the usual care group in terms of any education, frequency of follow-up, etc.
  • There was no attentional control provided in this study. Although the study demonstrated that the telephonic intervention was feasible for the majority of subjects, there was a 30% attrition rate. This points to practical difficulties in provision of such interventions and suggests that those who completed the study may have been those who were biased in terms of their expectations of effect or were most highly motivated to participate.
  • This is not generalizable to all patients with prostate cancer because the majority of survivors in this study underwent surgical treatment, and the population included only African Americans.

Nursing Implications

Telephonic approaches to provide education, counseling, and CST is a promising approach for the provision of patient care, but scheduling sessions, particularly when patients and caregivers are working full-time, is a challenge. This type of intervention appears to be effective in terms of symptom and side-effect management among patients who are receptive to this type of approach, but the impact on caregiver strain and burden is unclear.

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Carter, P.A. (2006). A brief behavioral sleep intervention for family caregivers of persons with cancer. Cancer Nursing, 29(2), 95–103.

Study Purpose

To test the feasibility and effectiveness of a brief behavioral sleep intervention for family caregivers of persons with advanced stage cancer

Intervention Characteristics/Basic Study Process

Each caregiver received an Actigraph on the wrist of the dominant hand and was asked to wear it for the next three days. During this time, the caregiver completed a sleep log to illustrate times out of bed, time to bed, awakening and out of bed, and times of disturbance. At week two, intervention group caregivers (n = 15) received the CASI (author developed sleep intervention), and the attention control group caregivers received body mechanics information and training. All caregivers completed the Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiological Studies—Depression Scale (CES-D), and Caregiver Quality of Life Index—Cancer (CQOLC) at week three and provided sleep log and Actigraph data. A booster CASI session was delivered to the intervention group at week four, and the attention group received a booster of the body mechanics material. The intervention incorporated stimulus control, relaxation therapy, cognitive therapy, and sleep hygiene. Participants were educated on sleep promotion techniques within the context of caregiving. Measurements of all study variables from both groups occurred in week five and two, three, and four months post-baseline.

Sample Characteristics

  • The sample included 30 participants.
  • The mean age of the sample of 30 family caregivers was 53 years (age range 21–85 years).
  • Females: 63% (both intervention and control groups) (n = 19)
  • Males: 27% (both intervention and control groups) (n = 11)
  • Participants had multiple cancer diagnoses, were at end of life, and were not in a hospice program.
  • Inclusion criteria required caregivers to be at least 21 years of age; identify themselves as family caregivers; have reported difficulty in beginning and maintaining sleep or non-restorative sleep for at least one month; and live with patients whose caregivers assessed them as having advanced stage cancer diagnoses.
  • Most caregivers were spouses (57%) or adult children (30%) and provided care for a mean length of 17 hours per day.
  • Eighty-seven percent of caregivers were Caucasian, and 13% were Hispanic.

Setting

  • Multi-site
  • Home
  • Central Texas USA

Study Design

A repeated measures experimental design was used.

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI) (used to measure caregiver sleep quality)
  • Actigraph sleep watch (used to measure sleep patterns [latency, duration, efficiency, and wake after sleep onset])
  • Sleep logs
  • Center for Epidemiological Studies—Depression Scale (CES-D) (used to measure caregiver depression symptoms)
  • Caregiver Quality of Life Index—Cancer (CQOLC) (used to measure caregiver quality of life)

Results

Pearson product correlations reported on how sleep duration and efficiency were “strongly negatively associated” with caregiver depression and quality of life over time; however, actual statistical results were not provided in this report. Overall sleep quality (PSQI) and sleep latency were strongly and consistently correlated with caregiver depression and quality-of-life scores over time. Quality-of-life scores were strongly and consistently positively correlated with depressive symptoms over time, according to the author. Caregiver quality of life and self-reported sleep quality improved for both groups over the duration of the study. Intervention caregivers showed greater improvements in PSQI total scores than did control caregivers at each time measurement. The difference between groups in PSQI score was only statistically significant at month four in the study (p = 0.03), in favor of the intervention group.

Conclusions

Delivery of a home-based caregiver sleep intervention may be helpful for caregivers who report sleep disturbances that dramatically influence their personal quality of life and ability to provide care to a family member with cancer. This intervention appears to be feasible and can be tailored to the caregiver.

Limitations

  • The sample had less than 100 participants.
  • The limited ethnic representation in sample limits generalizability of findings.
  • The limited sample size also affects the use of more powerful statistical analysis that would support efficacy of the intervention. 
  • It is unclear whether randomization occurred for the caregiver group assignment.
  • The author states a number of significant results; however, the actual data and statistics for these are not all provided.

Nursing Implications

Findings suggest that an intervention to improve caregiver sleep quality may be helpful and that poor sleep quality is associated with lower quality of life and depressive symptoms.

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Chambers, S.K., Girgis, A., Occhipinti, S., Hutchison, S., Turner, J., McDowell, M., . . . Dunn, J. C. (2014). A randomized trial comparing two low-intensity psychological interventions for distressed patients with cancer and their caregivers. Oncology Nursing Forum, 41(4), E256–E266. 

Study Purpose

To compare the effectiveness of nurse- and psychologist-delivered psychoeducational interventions for distressed patients and caregivers who had called a cancer helpline seeking support

Intervention Characteristics/Basic Study Process

Individuals who called the helpline were randomized to a five-session psychologist intervention using a cognitive behavioral approach or a single nurse-delivered session for education and support for self-management. All sessions were provided by telephone. Those in the single-session group were mailed a self-management resource kit, including written advice about stress management, problem solving, healthy lifestyle, and mobilizing support networks, along with an audio CD about relaxation exercises. All participants completed a baseline distress thermometer, and those who had a score of 7 or greater also received a follow-up phone call after the nurse session three weeks later. Study measures were obtained at baseline and at 3, 6, and 12 months. Caregivers and patients were not dyads because helpline calls were done individually.

Sample Characteristics

  • N = 132 caregivers   
  • MALES: 12%, FEMALES: 88%
  • KEY DISEASE CHARACTERISTICS: Various tumor types; disease stages and phase of care not reported
  • OTHER KEY SAMPLE CHARACTERISTICS: 42% of caregivers were spouse or partner.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Home  
  • LOCATION: Australia

Study Design

  • Randomized, two-group trial

Measurement Instruments/Methods

  • Distress Thermometer
  • Brief Symptom Inventory-18
  • Impact of Event Scale 
  • Post-traumatic Growth Inventory for perceived positive life changes 

Results

Of the patients and caregivers, 93% completed the single-session intervention and 53% completed all five psychologist interventions. In the nurse arm, the mean intervention duration was 46.51 minutes, and the psychologist mean session duration was 46.43 minutes. Distress-related outcomes decreased over time, and positive adjustment increased over time in both groups. Effects size over 12 months was 0.19 in the nurse intervention group and 0.2 in the psychologist group. Cancer-specific distress decreased significantly over time for caregivers (p < .001), and positive adjustment increased (p < .001) with no significant difference between groups. Thirty-five percent of those in the nurse group received a follow-up phone call because of their distress score, and 3% were referred for additional support services.

Conclusions

Both the brief nurse contact for psychoeducation and self-management support and the telephonic CBT approach interventions provided by a psychologist were associated with reduction in distress and improvement in positive adjustment among caregivers of patients with cancer who had contacted a cancer helpline.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Other limitations/explanation: With some instruments, whether only subscales were used in the study is not clear.

Nursing Implications

Findings suggest that caregivers, as well as patients, can benefit from a single-session nursing psychoeducational session provided by telephone and supported by self-management resource materials. Findings also showed that five telephonic sessions provided by a psychologist with a CBT approach also were helpful. Specifically, cancer-related distress can be approached effectively with a short, practical telephonic intervention for patients who identified a need for support by calling a helpline. Although this study has some design limitations in terms of sampling frame, it is very applicable for a real-world situation.

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Cohen, M., & Kuten, A. (2006). Cognitive-behavior group intervention for relatives of cancer patients: A controlled study. Journal of Psychosomatic Research, 61, 187–196.

Study Purpose

To compare the effectiveness of a cognitive behavioral (CB) group intervention for relatives of patient with cancer with a control group
 

Intervention Characteristics/Basic Study Process

The cognitive behavioral (CB) intervention consisted of nine structured, 90-minute group sessions. Individual groups had five to seven participants and were conducted by a senior social worker with psycho-oncology experience as well as training in group therapy and CB therapy. Participants were provided written materials at every session and audiocassettes or compact discs for home practice of relaxation with guided imagery. The CB intervention had a cognitive and a behavioral component. Cognitive techniques were taught to identify and challenge negative and automatic thinking patterns and beliefs. Participants were taught to restructure thoughts into more adaptive patterns, reframe, problem-solve, and find alternative strategies to use with recurrent and stressful situations. Behavioral techniques taught were relaxation, guided imagery, and deep breathing.

Sample Characteristics

  • The sample was comprised of 104 participants assigned to a CB intervention group (n = 52) or a control group (n = 52).
  • Mean age of participants was 53 years (range = 24 to 72 years).
  • The sample was 66% female and 34% male.
  • Caregivers did not have a present or past cancer diagnosis.
  • Participant relatives were mainly spouses (49%), children (20%), parents (16%), or others (14%).
  • Participant relatives’ diagnoses of cancer were breast (41%), colon (25%), prostate (9%), gynecologic (16%), and other (12%).

 

Setting

  • Single site  
  • Outpatient setting
  • Haifa, Israel

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

A repeated measures, controlled trial design was used.

Measurement Instruments/Methods

  • Global Severity Index (GSI) was calculated as the mean of all item scores on the Brief Symptom Inventory (BSI) to assess psychological distress. Internal consistency was good, ranging from 0.87 to 0.91.
  • Psychological Adjustment to Illness Scale–Self Rating (PAIS-SR): Internal consistency was good, ranging from 0.84 to 0.87.
  • Mini Sleep Questionnaire was used to measure problems with falling asleep, restless sleep, and early awakening in the morning. Internal consistency was good, ranging from 0.87 to 0.89.
  • Multidimensional Scale of Perceived Social Support was used to measure social support from significant others, family, and friends. Internal consistency was good, ranging from 0.92 to 0.95.
  • Compliance with home practice was assessed with two questions.
     

Results

There were significant group X time interactions for all of the psychosocial variables in the CB group but not in the control group. Significant main group effects were for psychological distress, psychosocial adjustment, and sleep problems but not for perceived support in the CB group but not the control group. Significant main time effect was for sleep difficulties and psychosocial adjustment. The between group effect size difference was 0.11–0.18.

There were significant improvements in perceived support from time 1 to time 3 (p < 0.0001) for the CB group but not for the control group.

Reliable Change Index (RCI) is a measure of clinical significance. RCI (6.5) showed clinically significant improvement in psychological distress from preintervention to follow-up in 30.8% (n = 16) of the participants in the CB  group as compared to  3.9% (n = 2) of the participants in the control group. Psychological adjustment, sleep problems, and perceived support levels for the CB group were also clinically significant (for PAIS, RCI = 2.2; for sleep difficulties, RCI = 14.8; for perceived support, RCI = 3.2).

On average, the amount of  thought monitoring was performed 2.7 (SD = 2.5) times per week at time 2 and 1.9 (SD = 1.7) times per week at time 3. Relaxation with guided imagery  was performed 3.4 (SD = 3.8) (time 2)  to 2.3 (SD = 2.9) times per week (time 3).

Conclusions

The results from this study indicate that the CB group intervention was effective in reducing psychological distress and sleep problems, and improving psychological adjustment for relatives of patients with cancer who participated. The CB intervention had a long-term effect that was maintained over the four-month follow-up.

Greater preintervention distress and a greater amount of  home-practice thought monitoring and relaxation/guided imagery compliance were significant predictors of the total change in participants’ level of distress.

The CB intervention was administered by a social worker who was highly experienced and familiar with psycho-oncology, group therapy, and CB therapy. Consequently, the study social worker was highly prepared to administer this CB group intervention. This indicates that the individual administering the CB intervention should be highly trained to replicate the successes of this research.
 

Limitations

  • The study has risk of bias due to no blinding, no randomization, and no appropriate attentional control condition. 
  • Subject withdrawals were 10% or greater.
  • The study had self-selection of control group participants in that they initially agreed to participate in the group intervention but could not attend due to other obligations.
  • The study had a high refusal rate and losses to follow up.

Nursing Implications

The CB group intervention can be effective for improving psychological distress, psychological adjustment to illness, and sleep difficulties of relative caregivers of patients with cancer. This intervention can have both short-term and long-term psychosocial effects. Nurses can provide referrals for a CB intervention for highly distressed caregivers or those who are having sleeping problems and issues with adjustment to their relatives’ illness.

Further research is needed to replicate this study using a randomized controlled design. Additionally, an abbreviated CB intervention for relatives of patients with cancer needs to be developed for caregivers who have time constraints.
 

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Given, B., Given, C.W., Sikorski, A., Jeon, S., Sherwood, P., & Rahbar, M. (2006). The impact of providing symptom management assistance on caregiver reaction: Results of a randomized trial. Journal of Pain and Symptom Management, 32(5), 433–443.

Intervention Characteristics/Basic Study Process

Dyads in the experimental group received four contacts over a 10-week intervention. (Two in-person contacts coinciding with regular visits to the oncology center; alternated with two telephone contacts approximately two weeks following each in-person contact.)

Cognitive behavioral intervention was directed toward the patient and caregiver dyad. Patients received information on self-care, cognitive reframing, coping strategies, and techniques for communicating needs for assistance with family members. Interventions for caregivers focused on etiology and strategies for managing symptoms, how to integrate into everyday activities, and how to better communicate with the patient and healthcare providers about symptom management. The intervention nurse assessed the caregivers’ perception of their involvement in and reaction to assisting the patient with symptom management; collaboratively selected strategies to implement; and evaulated the success of strategies to either continue or be revised.

Sample Characteristics

  • The sample included caregivers of patients with a solid tumor within their first two cycles of chemotherapy for treatment of new tumor (N = 125)—intervention (n = 59) versus standard of care (n = 66).

Study Design

A properly designed randomized clinical trial was used.

Measurement Instruments/Methods

  • Center for Epidemiologic Studies Depression Scale (CES-D)
  • Caregiver (burden) reaction to assisting with symptoms was measured by the following.
    • Total number of symptoms for which caregiver provided assistance
    • Total level of distress reported because of assisting with symptom management
    • Reaction (level of distress) score per symptom

Results

Caregivers in the experimental intervention group reported significantly lower total negative reactions and fewer assistances at 10 weeks than caregivers in the standard of care arm (p < 0.01).

Patients of caregivers in the experimental group reported significantly lower levels of symptom severity for which caregivers provided assistance.

Female caregivers in the experimental group reported less negative reactions to providing assistance than female caregivers in the control group (p < 0.01). Males in the control group reported less negative reactions per assistance than males in the experimental group (p = 0.08).

Caregivers who were younger than their patients reported less negative reactions to assisting with symptom management than caregivers who were the same age or older than their patients (p = 0.06).

Limitations

  • Demographic information about race and ethnicity of the sample was not described.
  • No description exists of the qualifications or training required for the intervention nurse nor do evidence-based guidelines exist for strategies used in symptom management.
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Manne, S.L., Kissane, D.W., Nelson, C.J., Mulhall, J.P., Winkel, G., & Zaider, T. (2011). Intimacy-enhancing psychological intervention for men diagnosed with prostate cancer and their partners: A pilot study. Journal of Sexual Medicine, 8(4), 1197–1209.

Study Purpose

To evaluate (a) the impact of an intimacy-enhancing therapy (IET) versus a usual care (UC) program on survivor and partner psychological outcomes, including distress, well-being, and relationship outcomes (relationship satisfaction and intimacy), (b) the impact of an IET on relationship communication, and (c) the role of preintervention levels of each outcome variable on post-IET intervention outcome variables  

Intervention Characteristics/Basic Study Process

Participants received assignment to either an IET or a UC group. The IET intervention consisted of  five 90-minute couple sessions delivered by a trained therapist. This person focused on improving couples’ ability to comfortably share their thoughts and feelings to promote mutual understanding and support for cancer concerns and to facilitate emotional intimacy. The IET program techniques evolved from cognitive-behavioral and behavioral marital therapy practice and other published communication skills interventions adapted for prostate cancer. Careful attention was made to ensuring treatment fidelity by videotaping sessions and using manuals to structure the intervention. UC group participants received standard clinic psychosocial care. The IET group received the same surveys following the fifth and final session of the IET (approximately two months post-baseline). The UC and IET participants who did not complete sessions received a second round of surveys eight weeks after baseline assessment.

Sample Characteristics

  • The sample (N = 71) included 34 participants in the UC group and 37 participants in the IET group.  
  • Mean age of participants in both groups was 60 years (SD = 8.35).
  • UC group males represented 34 (48%) survivors and no partners; IET group males represented 37 (52%) survivors and 2 (3%) partners.  
  • UC group females represented no survivors and 34 (47%) partners; IET group females represented no survivors and 35 (49%) partners.
  • Survivors had a diagnosis of stage 2 localized prostate cancer, an Eastern Cooperative Oncology Group score of 0, and mean time since diagnosis of eight months.
  • The sample was white (86%), well educated (83% had completed high school or beyond), and married (95%), and had mean relationship length of 27 years. 

 

Setting

  • Multisite
  • Outpatient setting
  • Memorial Sloan-Kettering Cancer Center and Fox Chase Cancer Center (northeastern United States)
     

Phase of Care and Clinical Applications

  • Transition phase after initial treatment
  • Late effects and survivorship; localized prostate cancer

 

Study Design

A pre/post-test pilot design was used.

Measurement Instruments/Methods

  • Mental Health Inventory: (a) Psychological Distress Scale assessed depressive and anxiety symptoms of patients and partners; coefficient alphas for patient survivors and partners exceeded 0.94 at baseline and second assessment, (b) Psychological Well-Being Scale assessed satisfaction with life, sense of future hopefulness, and feelings of calmness; coefficient alphas for patient survivors and partners exceeded 0.93 at both assessment times.    
  • Impact of Events Scale: Measured severity of cancer-specific distress; coefficient alphas for both survivors and partners above 0.92 at both assessment times. 
  • Cancer Concerns: Rated partner and survivor concerns about 10 cancer-related problems; the tool was developed for the study, and coefficient alphas exceeded 0.81 for both groups at both assessment times.
  • Dyadic Adjustment Scale (DAS): Assessed relationship functioning, satisfaction, and distress; coefficient alphas exceeded 0.90 for both survivors and partners at both assessment times.
  • Personal Assessment of Intimacy in Relationships: Assessed emotional closeness; coefficient alphas exceeded 0.82 for both groups at both assessment times.
  • Self-Disclosure/Perceived Partner Disclosure: Assessed degree to which survivors and their partners disclosed thoughts, information, and feelings about cancer to each other and perceived partner responsiveness.
  • Communications Pattern Questionnaire
     

Results

Seventy-three percent of IET couples attended 80% or more of the sessions, but another 21.6% of the IET group did not attend any sessions following random assignment to the IET group. Treatment fidelity on 114 of 138 sessions averaged 87.4%. Intervention survivors and partners rated the sessions as “quite successful,” but only 72% of the intervention group reported completion of homework assignments as part of the IET program. With study attrition, an intent-to-treat statistical analysis approach was used.

There were no significant treatment effects for general distress, cancer-specific distress, and relationship intimacy for either survivors or partners. There were no significant treatment differences for relationship communication for either survivors or partners. IET effects were largely moderated by baseline couple relationship and psychosocial factors (individual distress). Survivors who had high levels of cancer concerns at baseline significantly reduced those concerns post-IET. Moderating effects of preintervention levels for self-disclosure and perceived partner disclosure and responsiveness resulted from the intervention. The IET program improved cancer-specific distress, low intimacy, martial satisfaction, and communication if a couple experienced problems in these areas before the intervention.  
 

Conclusions

The IET had a marginally significant (p = 0.08) main effect on survivor well-being and improved overall outcomes for couples with fewer personal and relationship resources. Couples with more resources (e.g., higher educational level, stronger marital ties) experienced no improvement from the IET program.

Limitations

  • The sample was small, with less than 100 participants.
  • The sample was predominately Caucasian, heterosexual, and well educated.
  • Drop-out rate was high following randomization to the treatment group.

Nursing Implications

Interventions such as the IET may prove valuable for couples challenged by treatment and outcomes of prostate cancer treatment. As members of the healthcare team, nurses have an obligation to assess prostate cancer survivors about their overall coping skills, learning, and relationship needs to offer patient- and couple-centered interventions to improve the quality of their relationships and adjustment to living with prostate cancer.

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McMillan, S.C., Small, B.J., Weitzner, M., Schonwetter, R., Tittle, M., Moody, L., & Haley, W.E. (2006). Impact of coping skills intervention with family caregivers of hospice patients with cancer: A randomized clinical trial. Cancer, 106, 214–222.

Study Purpose

To evaluate whether adding a brief problem-solving intervention (i.e., COPE) to caregivers of patients receiving hospice cancer care would be superior to either standard hospice care alone or standard hospice care with emotional support

Intervention Characteristics/Basic Study Process

Intervention group: In addition to standard hospice care, the intervention involved giving three training sessions to caregivers using the COPE problem-solving technique as a coping skill to manage caregiving stress. COPE involves training caregivers how to use Creativity, Optimism, Planning, and obtaining Expert information when needed as well as how to use a homecare guide for advanced cancer. The intervention was done during visits to the caregiver by a trained nurse while a home health aide stayed with the patient. The visits were conducted within seven to nine days of recruitment, but the schedule was not clearly reported.

Control group II: Caregivers and patients received standard hospice care and supportive visits that focused on emotional support only. These visits were scheduled at the same times and frequencies as the COPE training occurred in the intervention group.

Sample Characteristics

  • The sample started with 329 caregiver/patient dyads but decreased at different data collection points.
  • Mean caregiver age was 60 years (SD = 15.27); mean patient age was 70.12 years (SD = 12.58).
  • The caregiver sample was 14.5% male and 85.5% female (average for three groups).
  • Caregivers had to be providing care to adult patients with advanced cancer newly admitted to hospice.
  • The average educational level of participants was slightly above high school education. 
  • No systematic demographics were found among participants in the three groups. 

Setting

  • Single site
  • Inpatient setting
  • Large, nonprofit, community-based hospice in southeastern United States

Phase of Care and Clinical Applications

  • End-of-life care phase
  • Elder care, palliative care

Study Design

A three-group randomized controlled trial design was used.

Measurement Instruments/Methods

  • Caregiver quality of life (QOL) was assessed using the Caregiver Quality of Life Index–Cancer (CQOL-C).
  • To assess caregiver symptom-related burden, the authors adapted the patient Memorial Symptom Assessment Scale (MSAS) by asking caregivers to rate their distress associated with 24 patient symptoms.  
  • Caregiver general mastery was assessed using a six-item scale where caregivers reported their feelings of control and confidence in caregiving.  
  • Caregiver burden and mastery specific to caregiving tasks was assessed using the Caregiver Demands Scale (CDS) to obtain scores for caregiving task burden and caregiving task mastery.

Results

Results of random effect regression models showed significant interactions (time by group) in the intervention group for three of the caregivers’ measured outcomes.

  • Caregiver QOL (p = 0.054)
  • Caregiver symptom-related burden (burden related to patients’ symptoms) (p = 0.001)
  • Caregiving task burden (p = 0.021), with main effect for time (p = 0.014), where increases in task burden scores increased over time

There were statistically significant group by time effects, showing that caregiver QOL was higher in the COPE (p = 0.033) and support groups, and symptom burden was lower in the COPE (p < 0.001) and support groups when compared to the usual care group.

Conclusions

Overall, the study findings show strong evidence of effectiveness of the COPE treatment among caregivers of patients in hospice care. In this group of caregivers, COPE improved caregivers’ overall QOL and caregiver symptom-related burden.

Limitations

  • The intervention might be expensive, impractical, or require training needs.*
  • Subject withdrawals were ≥ 10%.
  • Other limitations/*explanation: Details about the COPE  intervention that were given in the study were insufficient, which is possibly a result of publication space limitations, but additional detail would have made it easier to fully understand the nature of this intervention (e.g., how long did the COPE training sessions last? When specifically were the sessions conducted with the caregivers? Exactly where did the sessions take place?). However, the authors mentioned that the intervention manual is available upon request to those who may wish to replicate the study or use the intervention in caring for caregivers. The differences between the usual care and support group interventions were not clear.

Nursing Implications

Nursing care of caregivers of patients in hospice should involve focused interventions that extend beyond emotional support. COPE is an intervention that can be used with caregivers of patients with cancer in general, hospice or otherwise. This intervention is very promising. The fact that it improved some caregivers’ outcomes in hospice suggests that it can also be very effective under different contexts. 

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Meyers, F.J., Carducci, M., Loscalzo, M.J., Linder, J., Greasby, T., & Beckett, L A. (2011). Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: Simultaneous care educational intervention (SCEI): linking palliation and clinical trials. Journal of Palliative Medicine, 14(4), 465–473.

Study Purpose

 To examine effects of a standardized cognitive-behavioral educational intervention on quality of life (QOL) of patients and their caregivers

Intervention Characteristics/Basic Study Process

Patients designated one caregiver as their coparticipant in the study. Dyads were randomly assigned to intervention or standard care control groups. Those in the intervention arm received a copy of The Home Care Guide for Cancer and participated in three educational sessions with a trained educator. The first session was up to seven days prior to or on the day of entry into a clinical trial. Two additional sessions were done within the next 30 days. Sessions were used to reinforce learning by focusing on patient- or caregiver-identified problems. Usual care was not described. Data were collected at baseline and at 30, 60, 90, 120, and 180 days.

Sample Characteristics

  • The sample included 441 patient/caregiver dyads, with 331 dyads in the intervention group. 
  • Mean age for patients and caregivers was 61.5 years.
  • The male sample was 44% patient and 31% caregiver; the female sample was 55% patient and 68% caregiver.
  • Patients had various types of cancer, with the most frequent diagnoses being gastrointestinal, genitourinary, and thoracic cancers.
  • All patients had advanced-stage disease and were enrolled in phase 1, 2, or 3 clinical trials.
  • Of the caregiver sample, 49% worked full- or part-time, 55% provided four or less hours of care per day or week, 70% were spouses, 65% had college or graduate school education, and 29% had an annual income greater than $80,000.

Setting

  • Mutlisite  
  • Outpatient setting
  • Multiple cancer centers in the United States
     

Phase of Care and Clinical Applications

  • Active treatment
  • End of life and palliative care
     

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • City of Hope Quality of Life Instrument    
  • Social Problem-Solving Inventory
     

Results

Approximately 25% of dyads in both groups withdrew from the study by their own choice. Among patients, there was a five-point decline (100-point scale) in QOL over six months, with no difference between study groups. Among caregivers, those in the control group had QOL scores decline more than those in the intervention group (p = 0.02), according to reported predicted decline from baseline. Caregivers did not show any significant changes in problem-solving skills over time in either study group. The intervention was associated with a slower rate of decline in spiritual aspect of the QOL measure. Caregivers overall showed a decrease in rational problem-solving skills over time, and there were no significant differences between groups, suggesting that the slower decline in  QOL with the intervention were not likely a direct result of improved problem-solving skills.

Conclusions

Findings show some potential benefits in the intervention group, but as pointed out by the authors, differences were not likely as a result of improved problem-solving skills, which was the emphasis of the intervention. The study does not demonstrate convincing effects of this intervention for caregivers.

Limitations

  • The study did not have an appropriate control group or attentional control. 
  • The study sample had a relatively high drop-out rate.
  • Several aspects of the report were confusing: Inclusion criteria stated that patients receiving chemotherapy or radiation therapy were excluded, yet all were on clinical trials involving some type of treatment intervention. Treatments received were not stated. There was no description of usual care for the control situation.
  • The study had no blinding, so there was associated risk of bias.
  • The statistical analysis used was a predictive model, apparently to enable analysis in the face of missing data; however, there was no description of how much missing data there was or the percent of attendance at sessions. Analysis attempts to compare actual findings in controls with predicted results in the intervention group are not reasonable. There was no direct statistical comparison between groups or examination of demographic differences between groups, which could be expected to affect results.
  • The control group was much smaller than the intervention group, questioning power of analysis across groups.
  • Subjects tended to be highly educated and in a higher socioeconomic group; findings may not be widely generalizable.

Nursing Implications

The study's drop-out rate suggests that this intervention may not be practical or acceptable because most of these were by individual participant choice. The study does not provide convincing evidence of effectiveness of this intervention on quality of life for patients or caregivers.

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Onyechi, K.C., Onuigbo, L.N., Eseadi, C., Ikechukwu-Ilomuanya, A.B., Nwaubani, O.O., Umoke, P.C., . . . Utoh-Ofong, A.N. (2016). Effects of rational-emotive hospice care therapy on problematic assumptions, death anxiety, and psychological distress in a sample of cancer patients and their family caregivers in Nigeria. International Journal of Environmental Research and Public Health, 13, E929. 

Study Purpose

To evaluate the degree to which a rational emotive behavioral approach and techniques can benefit patients and family members in hospice care

Intervention Characteristics/Basic Study Process

A manual for the intervention approach was developed to guide the treatment process. It was based on a cognitive behavioral approach, including cognitive restructuring, confrontation, therapeutic alliance, acceptance, dialogue, reframing, use of metaphors worksheets, and motivational activities. The intervention was provided for 10 weeks in 45-minute sessions weekly, with four weeks of follow-up meetings in each household. Study assessments were conducted at baseline, after the 10-week intervention, and after the four weeks of follow-up, using self-report instruments and structured interviews. Participants randomized to the control intervention received usual care involving spiritual support, caregiving, counseling, etc., for the same amount and duration of time.

Sample Characteristics

  • N = 32 patients and 52 family caregivers   
  • MEAN AGE = 48.33 years (SD = 6.17)
  • MALES: 15.38%, FEMALES: 84.62%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast, cervical, and prostate cancers; all patients were at terminal stage of disease. 
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority lived in rural settings.

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: Nigeria

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Patients and Family Caregivers' Assumptions Questionnaire
  • Death Anxiety Questionnaire
  • Kessler Psychological Distress Scale

Results

Overall baseline problematic assumptions and death anxiety were high, and distress scores showed severe distress. Respeated measures analysis of variance (ANOVA) showed that the intervention program had a significant effect on problematic assumptions (p = 0.00), death anxiety (p = 0.00), and distress (p = 0.00) in caregivers and patients compared to those in usual care. This difference was maintained at follow-up.

Conclusions

The findings show that cognitive behavioral techniques and the specific approach used here were effective in reducing problematic assumption, death anxiety, and psychological distress among patients with cancer and their family caregivers.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • The study involved mainly patients and family members living in rural Nigeria; the results may not be applicable to other cultural groups.

Nursing Implications

The findings demonstrated that cognitive behavioral approach techniques are helpful in reducing stress and anxiety in patients in hospice and their informal caregivers. Nurses can incorporate these types of approaches into usual counseling and supportive interventions with caregivers and patients.

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