Supportive Care/Support Interventions

To evaluate the evidence concerning the efficacy of Internet support groups (ISGs) in reducing symptoms of depression

• Databases searched were PubMed, PsycINFO, and Cochrane Database.
• Searched keywords were computer, Internet communication, and support.
• Studies were included if they employed an online peer-to-peer support group, incorporated either a depression outcome or involved an Internet support group relating to unipolar depression, or reported either quantitative or qualitative data.
• Authors did not specify exclusion criteria.
   

• Investigators retrieved a total of 158 studies.
• Investigators recorded study characteristics regarding design and other aspects of study quality. Investigators used no other method of quality evaluation.
• Of the studies retrieved, 16 involved a single component of peer-to-peer support. Of these 16, 4 reported that ISG had had a positive effect on symptoms of depression. Five of the 16 studies involved women with breast cancer.
• Twelve studies involved intervention components in addition to ISG. Only two of these reported positive results.
• Studies employed a bulletin board, chat room, or mailing list—alone or in combination. The duration of ISG intervention was 12 minutes to 12 months. Approximately 50% of interventions were moderated interventions, and the moderator was a healthcare professional.
• Only one study focused on rural participants.
• Of the final set of 28 studies, 9 involved patients with cancer. Most of these patients were women with breast cancer.
   

• The final number of studies included in the sample was 28.
• The mean range of participants was 10–2,373.
• Across studies, the median age range of patients was 26–65 years. Few samples focused on men, and most studies had a preponderance of women. 

• Multicomponent studies were less likely to yield significant positive outcomes than were stand-alone interventions (p = 0.01).
• Breast cancer ISGs were more successful than others (p = 0.02); however, all the studies involving ISGs originated from a single research group
• Authors noted no differences in outcomes between interventions involving chat rooms versus interventions involving static content.
• Authors noted no relationship between ISG participation and duration of intervention or ISG participation and outcomes or length of follow-up.
• Most studies were of low quality. Authors noted a correlation between low study quality and highly positive findings.
   

There is a need for high-quality research regarding the effect of ISGs on symptoms of depression.

This systematic review included data from studies available as of July 2007. Internet use and and social networking have increased since 2007—a fact that could alter the findings about the use and effect of ISGs. More research in this area is needed.

This review points to the need for high-quality research in this area. Theoretically, ISGs could be important for users who are isolated or unable to access face-to-face services readily; therefore, further research should be done.

STUDY PURPOSE: To examine the effect of a variety of supportive care measures on quality of life (QOL), depression, anxiety, coping skills, and self-efficacy among men with prostate cancer in various states of care. (Note: Many more outcomes were reported among studies, but the four above were the most frequent.)

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 26  
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,740 participants
• SAMPLE RANGE ACROSS STUDIES: Less than 50 to over 200. Seven were pilot studies. 
• KEY SAMPLE CHARACTERISTICS: Twenty studies were based in the USA (most were government-funded or national research groups), two were based in Canada (similar funding as in USA), and others were based in Ireland, Sweden, or Hong Kong. Other funding sources were public, private, or not described. Seven studies were rated at high risk for bias. One study included patients with breast cancer and prostate cancer in the power calculation. Control group designation, services, or support were inconsistently described across trials.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Most trials reported no effect of supportive care measures on the stated outcome variables. The findings indicated appropriate interventions and outcomes measures, but small samples with insufficient power contributed to lack of evidence for improvements. Recommendations included resources to support the design, conduct of trials, and reporting (CONSORT guidelines) improvements. Also included were recommendations to diversify sampling across sociodemographic profiles to include unpartnered men who may be less likely to have a social support network, address all stages of care, provide clear descriptions of usual care and control group activities, and use reliable and valid outcome measures.

• Mostly low quality/high risk of bias studies
• Minimal confidence can be put in the study findings as a result of the design and analysis limitations.

The value of this systematic review is that supportive care probably works, but the evidence is lacking because of inconsistencies in study design and reporting. Clear, perhaps standardized, descriptions of the broad variety of interventions called \"supportive care\" are needed. Comparative information was not available across more than two to six trials of a particular intervention. The effect of supportive care in patients with prostate cancer can be examined by creating studies that have strong design quality and methodology. The authors’ provide important recommendations for study areas to be addressed so that results are comparable. One finding is seldom sufficient to change or influence practice.

To review systematically the efficacy of psychotherapeutic and antidepressant interventions for cancer patients with depression or symptoms of depression

• Databases searched were PubMed, CINAHL, Cochrane Library, Database of Abstracts and Reviews of Effects (DARE), Cochrane Database of Systematic Reviews (CDSR), Cochrane Controlled Trials Register (CCTR), PsycARTICLES. In addition, investigators searched reference lists manually.
• Search keywords were terms relevant to depression and cancer from articles relevant to the review and medical subject headings (MeSH) per the National Library of Medicine. Intervention terms included antidepressant agents, SSRI, fluoxetine, and cognitive therapy.
• Studies included were randomized controlled trials involving pharmacologic and psychotherapeutic interventions for depression in adult patients with cancer. All study reports were in English.
• Excluded were studies involving the combination of pharmacologic and psychotherapeutic interventions, interventions involving complementary or alternative medicine, or educational strategies.
   

• Investigators retrieved a total of 164 studies.
• Evaluation included assessment by Cho and Bero's instrument for measuring methodological quality.

• The final number of studies assessed was 24, with the following sample range across studies:
  • Pharmacologic: N = 892, with a range of 40–549.
  • Psychotherapeutic: N = 2,518, with a range of 36–450.
• Participants in the studies had multiple and different disease sites.
   

• Results reflected 6 pharmacologic trials and 18 trials involving psychotherapeutic interventions.
• None of the trials using antidepressants reported avoiding or monitoring use of cointerventions.
• One trial found paroxetine to be effective in cases of major depression; one found paroxetine to be effective in reducing symptoms of depression.
• One trial reported that fluoxetine was ineffective in patients who presented with major depressive disorder, and response was not significantly higher than that with placebo. Two other trials reportedly showed the effectiveness of fluoxetine in reducing symptoms of depression.
• The majority of psychotherapeutic trials involved use of cognitive behavioral therapy. Other interventions were social support, counseling, support, and education and psychotherapy.
• Two studies examined the use of computer-based assessment and care planning. Most did not control for co-interventions and aimed at treatment of depression.
• Symptoms were measured at various time points and with various instruments. Of assessed studies, 42% demonstrated some significant improvement in depression as measured.

Some evidence suggests that antidepressants are effective in reducing symptoms of depression in patients with cancer, and overall tolerability of antidepressants appeared to be good. Cognitive behavioral therapy was effective in reducing symptoms of depression. An intervention that might be effective is the social-support group.

• Almost none of the assesed trials monitored, avoided, or reported cointerventions that could impact symptoms of depression.
• Most psychotherapeutic trials were single-center trials, a fact that limits generalizability.
• Patients recruited to participate in many of the studies did not have significant psychological morbidity.
• Many pharmacologic studies did not report tolerability data.
• Overall, few studies examined the use of antidepressants in patients studied. No studies were conducted of palliative care patients.

Findings suggest that antidepressants, cognitive behavioral interventions, and support group interventions can have a positive impact on symptoms of depression in patients with cancer. Variability in findings suggests that these interventions are likely to be of most benefit to patients who actually have clinically defined symptoms of depression. There is a need for further research of the efficacy of antidepressants in the patients studied.  Studies in this area should include data regarding use of any cointerventions for depression.

Long-term follow-up to evaluate quality of life after support group intervention in a randomized group of women with primary breast cancer presenting for postoperative radiotherapy.

The current study is a long-term follow-up 5–9 years after randomization into groups. The intervention and control groups were stratified by chemotherapy or nonchemotherapy treatment. The intervention was a one-week support group with four days of follow-up two months postintervention during residential care at the Foundation of Lustgården Mälardalen. The intervention involved lectures and group discussions about the etiology of cancer, risk factors, treatment, physical and psychological effects, and coping strategies. Patients engaged in physical exercise, relaxation, Qigong, and nonverbal communication exercises, as well as art and dance therapy. All participants completed questionnaires at baseline and follow-up questionnaires at 2, 6, and 12 months postintervention. The control group participated only in routine follow-up at the Department of Oncology or the Department of Surgery.

• N = 382 (final sample); 191 in intervention group and 191 in control group
• AGE RANGE: 30–83
• MALES: 0 %, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients were newly diagnosed with primary breast cancer at the beginning of the parent study.

• SITE: Single site    
• SETTING TYPE: Outpatient   
• LOCATION: Department of Oncology at the Central Hospital in Västeräs, Sweden

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care 

• Prospective randomized trial
  • Long-term follow-up comparison of test scores at baseline, 12 months, and at end

• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)
• Fatigue Questionnaire (FQ)

Fatigue symptoms improved over time, which was a significant finding in the intervention and control groups. Being upset about hair loss improved over time in the intervention group. High anxiety scores improved over time and were not significantly different between the two groups in long-term follow-up. Depression scores were high at follow-up for seven women in each group, and no significant difference was found at baseline and postintervention, adjusting for covariates. Neither group showed improvement between the 12-month follow-up and long-term follow-up. 

Effects of support group intervention may provide a sense of security that can fade over time, reversing improvements in anxiety and depression. Treatment-related fatigue may improve over time. Significant improvement was found in cognitive function, body image, and future perspective, but no significant effect was found on levels of anxiety and depression.

• An average of 6.5 years elapsed between the parent study and the follow-up study.
• Participants were lost to follow-up between the parent study and the follow-up study.
• No initial need for an intervention was conducted.

Women who have received chemotherapy have greater symptom severity and may benefit more on global health and cognitive function fatigue, when compared to women who have not received chemotherapy. Additional research is needed to evaluate the influence of exercise and psychosocial support interventions, according to patient needs for content, duration, and an assessment of spiritual well-being using the Functional Assessment of Chronic Illness Therapy (FACIT).

To determine if, compared to individuals receiving usual care, participants in intervention groups would report lower levels of anxiety, depression, and unmet supportive care needs along with improved physical and emotional functioning

• Patients were randomly assigned to one of three supportive care models: UC (control), O/GP (oncologist/GP), or TCW (telephone caseworker). Participants completed three computer-assisted telephone interviews (CATIs) conducted by trained interviewers: one each at baseline and at three and six months.
• Data obtained from participants in the UC model were used only to assess the impact of supportive care models.
• The O/GP model included two copies of sheets listing concerns: One sheet was mailed to the oncologist, so he or she would know what concerns to discuss at the next appointment. The other sheet was for records.
• The TCW model consisted of telephone interviews conducted by oncology nurses with training in by-telephone interviewing. Interviewers discussed the content of TCW sheets, which listed issues of concern that patients had expressed. TCW interviewers followed up at six-week intervals to assess coping.

• The sample was composed of 356 participants.
• Mean patient age in the UC (control) group was 57.4 years. The age range in the UC group was 28–75 years. Mean patient age in the O/GP group was 58.3 years. The age range in the O/GP group was 37–75 years. Mean patient age in the TCW group was 57.8 years. The age range in the TCW group was 33–75 years.
• The number of females in the sample was 257. The percentage of females in the sample ranged from 71.8% through 72.5%. The number of males in the sample was 99. The percentage of males in the sample ranged from 27.5% through 28.2%.
• The percentage of participants with nonlocalized breast cancer ranged from 48.7% through 49.2%; with nonlocalized colon cancer, 50.8% through 51.3%

• Single site
• Home
• New South Wales, Australia

• Phase of care: active treatment and transition
• Clinical application: late effects

Parallel-group, prospective randomized controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire, version 3.0 (EORTC QLQ-C30 version 3.0)
• Supportive Care Needs Survey-Short Form (SCNS-SF34), to measure perceived need for care
• 10 items from the Needs Assessment for Advanced Cancer Patient (NA-ACP)
• Perceived improvement in patient communication with health care practitioners was measured at the third CATI by means of one question, on a 5-point Likert scale: “Participating in this study made it easier to discuss my health care needs and issues with my doctors and other health care practitioners.”

• Authors observed no overall intervention effect.
• Members of the TCW group were more likely (p < 0.0001) to have issues discussed and referrals recommended than were those in the O/GP group. This was particularly true in regard to unmet psychological need (p < 0.01), need relating to daily living (p < 0.01), health service/information need (p = 0.01), and physical need (p < 0.01).
• Compared to oncologists and GPs, case workers were more likely to discuss anxiety (p = 0.01) and unmet psychological needs (p < 0.01).
• Oncologists and GPs were more likely (p = 0.02) to discuss unmet patient care and support needs.
• Authors noted no significant intergroup differences in regard to proportion of participants with elevated anxiety and depression at any of the three time points.
• QOL scores improved within study groups across times, but authors detected no significant between-group differences.

Authors noted no significant intervention effect in this study, with the exception of improved physical functioning at six months for the TCW group.

• Individuals who were too distressed or unwell to participate were excluded from the study. These patients may have been the very ones who most needed the intervention. 
• Authors provided no information about or consideration of disease stage, treatment phase, or other symptoms that can affect the outcomes the study measured.

Nurses should continue to explore ways to reach patients, at the time of diagnosis and beyond treatment, that can assist patients in psychosocial functioning. The field needs tools to make this easier; nurses need ways to implement care efficiently. The study did not show telephonic intervention to be effective.

To evaluate the effects a brief telephone intervention on women experiencing a recurrence of breast cancer

Women were randomly assigned to either a telephone-intervention group (TG) or a control group (CG). TG received 4–8 counseling/information sessions by telephone at weekly intervals. Session content reflected primary patient concerns and common domains from a quality-of-life (QOL) model. After the first session, patients received an information packet. The packet consisted primarily of National Cancer Institute pamphlets. Counselors were breast cancer recurrence survivors at least one year postrecurrence. Assessments were completed at baseline, three months, and six months.

The study was conducted by SWOG (formerly the Southwest Oncology Group)—an organization, supported by the National Cancer Institute, that conducts clinical trials relating to cancer in adults.

• The sample was composed of 305 women experiencing the first recurrence of breast cancer.
• Characteristics of participants in both groups were well balanced except that, in the TG group, more patients received chemotherapy; in the CG group, more patients received hormone therapy.

Multisite

• Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), to measure emotional well-being
• Center for Epidemiological Studies Depression Scale (CESD), to measure depression

Secondary-outcome assessments:

• Four-item scale as proposed by Reynolds et al., to measure social support
• Life Orientation Test (LOT), to measure optimism and pessimism
• Three-point question, to measure surprise regarding recurrence
• Sense of Coherence Scale (Antonovsky), to measure sense of coherence.

Support services utilized and satisfaction with the telephone intervention were requested.

The telephone intervention was feasible and well accepted, but authors noted no benefits associated with the intervention, in regard to either emotional well-being or depressive symptoms. Patient distress started and remained very high in this sample. Statistically significant was the fact that more CG patients progressed during the six months of the study than did members of the TG group.

This is a well-designed RCT with adequate sample size; however, the study’s generalizability is unclear, given that the patients came from multiple institutions across the United States. The catchment cannot be precisely described, and characteristics of refusing patients were not reported. This sample included high levels of psychological and disease-related disability, and telephone calls from a nonprofessional may not have been an appropriate means of modifying patient distress. The study presents no significant findings.

To test the hypothesis that depression and fatigue would be decreased more in the Sisters Tell Others and Revive Yourself (STORY) intervention group than in controls

The STORY intervention was a therapeutic activity delivered to a group via teleconference, using information and storytelling to increase social connections among African American women with breast cancer. A series to teleconferences was facilitated by two social workers with groups of 10 patients. The series was done weekly for eight weeks, and every other week for two weeks. Participants received small stipends during the study. Patients were randomly assigned to the STORY intervention or usual care. This particular report used secondary analysis to determine the impact of this intervention on depression and fatigue.

• N = 168
• MEAN AGE: 56.7 years
• RANGE: 32-83 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.

• SITE: Single site
• SETTING TYPE: Not specified
• LOCATION: Southeastern United States

• Randomized, controlled trial

• Profile of Mood States Short Form (POMS-SF)

There was no significant difference in fatigue or depression between study groups.

The psychoeducational intervention delivered via teleconference as tested here did not demonstrate an effect on fatigue or depression.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• The single instrument used may not have been the best for measurement of these symptoms.
• The educational content regarding how to manage fatigue and depression are not described, and from the description that is provided, it is not clear that patients were educated about evidence-based approaches to combat fatigue.
• It is unclear whether levels of fatigue and depression were high enough to expect to see a reduction with an intervention.

The psychoeducational and supportive intervention tested did not show an effect on depression or fatigue. This report does provide information regarding using a teleconference approach to provision of a group intervention, which might be applicable in a number of situations to facilitate patient involvement in this type of activity. Further research regarding the most effective methods of delivery of educational and supportive interventions is needed.

To evaluate the effects of the hospital-based palliative care team on care for patients with cancer

The hospital-based palliative care team visited intervention patients “regularly” during the one-week study period. Team members including physicians, nurses, chaplains, and social workers provided advice about medications and taught patients and families skills to relieve physical symptoms, provided emotional support, and assisted with truth-telling and preparation for death. Data were collected at baseline and one week later.

• N = 60
• MEAN AGE = 57.5 years (SD = 14.62)
• MALES: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: Patients with advanced cancer with palliative care needs
• OTHER KEY SAMPLE CHARACTERISTICS: Patients hospitalized in a medical center in Taiwan; unlikely to die or be discharged in 24 hours

• SITE: Single site
• SETTING TYPE: Inpatient   
• LOCATION: Taipei, Taiwan

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

Quasi-experimental study with a pretest-posttest design

• Symptom Distress Scale (SDS)
• Hospital Anxiety and Depression Scale (HADS)
• Spiritual Well-Being Scale
• Social Support Scale

No significant difference was seen in anxiety and depression between the control and intervention groups after one week of palliative care. Improvement was seen in edema, fatigue, dry mouth, and abdominal distention.

Nurse interventions improved symptom management for the intervention group; however, in the short timeframe of this study emotional disturbances were not affected. Cultural implications are important here; death is a taboo topic in Chinese culture, and patients' understanding of their terminal disease is low and rarely discussed.

• Small sample (< 100)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Patients were given the choice of usual care plus visits from the palliative care team versus usual care alone. The timeframe was only one week, and the number of visits and disciplines of the palliative care team were not clearly described. Nurse interventions for some physical symptoms are described very generally; no interventions for depression or anxiety are described.

Palliative care consultation may benefit many symptoms of patients with cancer, but without clear interventions for depression and in this short timespan, little effect is apparent.

To evaluate the effects, in women with breast cancer, of moderated and peer-led online support group format on symptoms of depression and degree of participation

Investigator distributed recruitment material via postal mail, online, or through nonprofit organizations or the media. Interested women contacted the investigator after receiving or seeing recruitment material. Participants were placed into a moderated or peer-led group, in groups of 15 according to time of recruitment. All online support was accessed via a university-owned web page devoted to the work. Participants could not access groups to which they were not assigned. Moderators were master's-prepared social workers with experience with online and telephone help for people with cancer and their caregivers. Investigators obtained study measures at baseline and at 6, 12, and 16 weeks. The group was maintained for 12 weeks.

• The sample was composed of 50 participants.
• Mean patient age was 52.22 years, and the age range was 28–77 years.
• All participants were female.
• All participants had breast cancer and were to have completed treatment within the 32 days prior to inclusion.
• Most participants were married and white, and they reported an income above $50,000 annually. Most had stage I or II cancer and had received multimodal therapy. Of all participants, 96% were not taking any antidepressant.
   

• Single site
• Home 
• Newark, Delaware, United States
   

• Phases of care: multiple
• Clinical applications: late effects and survivorship

Longitudinal two-group design

Center for Epidemiological Studies Depression Scale (CESD)

At the end of the study, findings revealed no significant effects, on symptoms of depression, in regard to group, time, or time by group format. CESD scores in peer-led groups declined slightly at all study time points but were not significantly different from the scores of moderator-led groups. In both groups, symptoms of depression were mild. More messages were posted and read in moderated groups than in peer-led groups.

The study showed no effect of peer- or moderator-led online support groups on symptoms of depression in women with breast cancer.

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no blinding and the characteristics of the sample.
• The CESD was not sensitive enough to pick up significant changes, and the study was probably underpowered.
• The sample was self-selected, and participants tended to be affluent. Results would not necessarily be applicable to other groups. 
• Women with higher depression scores were in the peer-led group. Overall, all participants had low depression scores.
   

This study does not provide strong support for the effectiveness of either peer-led or moderated online support groups on symptoms of depression; however, at baseline the depression scores of most participants were fairly low, and study groups were not balanced on baseline depression symptoms. It is not clear if such support efforts are beneficial to individuals who do not have a high level of depression symptoms. This finding could have influenced study results. Research in this area should stratify samples on the basis of the level of symptoms at baseline.

To determine whether centralized telephone-based care management and automated symptom monitoring can reduce depression and pain in patients with cancer

Participants in the intervention group received centralized telecare management, conducted by a nurse-physician specialist team, and automated home-based symptom monitoring by means of interactive voice recording or Internet. The control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

• The sample was composed of 405 participants, 202 in the intervention group and 203 in the control group.
• In the intervention group, mean patient age was 58.7 years (SD = 11.0). In the control group, mean patient age was 59 years (SD = 10.6 years).
• Most participants, more than 60%, were female.
• The sample included cancers of diverse types and stages.
• To be eligible, patients had to have depression, pain, or both as defined by a score of at least 10 on the Patient Health Questionnaire-9 (PQ-9) or a score of at least 6 on the Brief Pain Inventory (BPI).

• Multisite
• Outpatient
• Indiana, United States

Random controlled trial with double blinding, with stratified randomization by symptom type (pain only, depression only, or both pain and depression)

• Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure severity of depression
• Brief Pain Inventory (BPI), to measure severity of pain
• A single-item 0–10 scale, to measure overall quality of life
• SF-12, to provide physical-component and mental-component summary scores
• Generalized Anxiety Disorder Scale, to measure anxiety
• Somatic Symptom Scale, to measure physical-symptom burden

• The number of patients with pain was 274. Over the 12 months of the trial, the 137 patients in the intervention group had greater improvements in pain severity, as measured by BPI scores, than did the 137 patients in the usual-care group (p < 0.001).
• The number of patients with depression was 309. Over the 12 months of the trial, the 154 patients in the intervention group had greater improvements in HSCL-20 scores than did the 155 patients in the usual-care group (p < 0.001). The HSCL-20 scores of the intervention group decreased at least 50%.
• The standardized effect size for between-group differences, at 3 and 12 months, was 0.67 and 0.39, repectively, for pain and 0.42 and 0.41, respectively, for depression.
• Compared to the usual-care group, the intervention group had better outcomes in several health-related quality-of-life domains.

The intervention may be effective at reducing pain and depression. The intervention proved to be a feasible care approach for geographically dispersed urban and rural oncology practices.

Lack of control over type of cancer treatment and over the time lapse since treatment might have affected study findings.

Cost will be involved in training the care manager and in hiring trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Studies show mixed results regarding effect of by-telephone patient management; further work in this area is warranted. Use of technology may be a viable approach to ongoing patient support.

To determine the effects of a spiritual care and support program on levels of depression in patients with leukemia

Patients in intensive care randomly were assigned to the spiritual care or control groups. Patients in the control group could receive the spiritual care program after the completion of the study. The program encouraged a supportive presence through the expression of feelings, needs, and concerns, and provided education regarding disease, treatment, and supportive touch. To support religious rituals, patients were provided a prayer rug, rosary, and a veil for women. Participants also had access to an MP3 player and earphones to listen to prayers and passages from the Quran. Readings of prayers and the Quran at the bedside were implemented by a clergyman. Study measures were obtained at baseline and on day 3 by an individual blinded to study group assignment.

• N = 64  
• MEAN AGE = 41.68 years
• MALES: 60.5%, FEMALES: 39.5%
• KEY DISEASE CHARACTERISTICS: All participants were diagnosed with leukemia, and most participants had acute myeloid leukemia.
• OTHER KEY SAMPLE CHARACTERISTICS: About 50% of participants had a high school education. The mean time since diagnosis was 24.32 months in the experimental group and 18.08 months in the control group.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Iran

• PHASE OF CARE: Active antitumor treatment

Single-blinded, randomized, controlled trial

• Depression Anxiety and Stress Scale (DASS)

The mean postintervention score in the experimental group was lower than that of the control group (p < .001), and the change in depression scores in the intervention group was marginally significant (p < .07). Baseline data and changes for both groups were not provided.

This intervention, which included support and psychoeducational components along with spiritual support, was associated with reduced depression scores.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: Findings may not be applicable to other cultural groups and individuals. The study had a very short duration. The treatment involved was not described, so it is not clear whether some patients were more acutely ill than others.

Supportive and psychoeducational interventions that include a component of spiritual support may be beneficial for hospitalized patients with leukemia. The provision of holistic supportive care is a principle of nursing care. These findings provide marginal support for the efficacy of these interventions during short-term hospitalization. There were several study limitations.

This study was designed to evaluate interventions targeted to occur at the point when treatment is ending—a time when distress and concerns are known to increase. It also targets younger women; as some studies report, younger women are at greater risk for psychological distress and face different challenges than older women do.

Women with breast cancer were assigned to a three-arm clinical trial. In the two active arms, the women received either an educational intervention, which provided information about their disease and treatment, or information about nutrition, featuring a low-fat, high-fruit-and-vegetable-eating pattern. Both active treatment arms received four group sessions, meeting once per month for four consecutive months. Sessions were led by professionals, and interactions between participants were kept to a minimum. The control arm was standard medical care. Random assignment assessments occurred at baseline, then 4 months, and 13 months later (corresponding to immediate post-intervention and nine months post-intervention.)

• N = 252
• AGE: 50 years and younger
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS:  Diagnosis of stage 0, I, or II breast cancer with no more than 10 positive lymph nodes
• OTHER KEY SAMPLE CHARACTERISTICS: Within two months of completing nonhormonal adjuvant therapy

• SITE: Multi-site
• LOCATION: Recruited from oncology clinics and medical offices in a single state

• RCT

• Depressive symptoms were assessed using a 10-item version of the CESDS.
• Health-related quality of life was assessed using the SF-36 from the Medical Outcome Studies.
• Mediating measures also were assessed including intrusive thoughts, self-efficacy, cancer concerns, self-concept, and coping.

At the 13th-month assessment, participants in the nutrition arm reported significantly fewer depressive symptoms, and in the education arm, marginally fewer depressive symptoms were reported than in the control arm. The difference between the two active treatment arms was not significant. The mediating factors also were identified as contributing by enhancing self-efficacy expectations, reducing some concerns regarding morbidity and mortality, lessening intrusive thoughts about illness, and buffering self-concept perceptions.

• Compliance with treatment sessions was higher in the nutrition arm than in the education arm.
• The trial focused on early-stage disease; if generalizability exists in patients with advanced disease is not known.
• The sample was composed largely of Caucasian, middle-class women in one state. 
• The sample size was adequate, but little diversity of the sample limits generalizability. 
• The difference between the two treatment arms was not significant.

To evaluate outlook, an intervention to assist patients address emotional and existential needs, in people living with advanced disease yet not in the final months of life. If improvements were demonstrated, it could improve understanding of intervention in early versus late palliative care contexts.

Three-arm randomized controlled trial testing the effect of Outlook, with an attention control (RM) and a true control (usual care UC). Baseline interview completed in person or on the phone, then randomized 1:1:1. Participants assigned to Outlook were interviewed in person three times during a one-month period after the baseline interview. Session 1 was life review; session 2 was issues of forgiveness, regret, things left unsaid, or undone; and session 3 was heritage and legacy. Interviews were a week apart and lasted 45 minutes. Participants assigned to RM met with the interventionist in person three times during a one-month period and listed to a relaxation CD for 40 minutes. UC participants were not contacted. Interventionists were clinical social workers trained in delivering standardized interventions following a manualized script. Sessions were audio recorded.

• N = 221   
• AGE: Mean = 67.8 years
• MALES: 96%  
• FEMALES: 4%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease
• OTHER KEY SAMPLE CHARACTERISTICS: Non-hospice eligible, veterans

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Durham, North Carolina

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS:  Elder care, palliative care

Three-arm randomized controlled trial testing the effect of Outlook compared with an attention control (relaxation meditation [RM]) and a true control (usual care [UC]) on patient QOL, functional status, and emotional well-being.

Primary outcomes:

• Preparation and completion: QUAL-E a 31-item validated measure of QOL at the end of life

Secondary outcomes:

• Anxiety: Brief Profile of Mood States
• Depression: Center for Epidemiological Studies-Depression scale
• Quality of Life: FACT-General FACT
• Spiritual Well Being: Functional Assessment of Chronic Illness Therapy-spiritual well-being.

The study compared change in primary and secondary outcomes over time between outlook and both the RM and UC groups. Outlook participants had higher improvements in mean preparation (p = 0.02) and mean completion (p = 0.04) at five week follow-up compared with UC. The differences did not persist for the seven week follow-up. Compared to the RM group, Outlook participants did not have a significant difference in preparation and completion at either follow up. Outlook social well-being was improved over RM at the seven-week follow-up. Outlook did not show significant difference over time in QOL, anxiety, or depression. Qualitative interview participants (15%) described Outlook at helpful. Participants valued the opportunity to review life memories as a source of strength and to identify unresolved issues.

Outlook did not demonstrate sustained improvements in preparation, anxiety, or depression and overall QOL compared to RM in adults with advanced illness who were not hospice eligible. Outlook as an intervention was positive for patient quality of life in reviewing memories as a source of strength, and releasing unresolved emotions and concerns.

• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results

The structured Outlook intervention which assists patients to review and resolve important life issues and concerns is valuable for patients with terminal illness, including patients with cancer. Nurses can assess patients for distress and ensure that opportunities and referrals with support resources are explored. This would be relevant to the hospice setting.

To compare the effectiveness, for women with a primary breast cancer, of experiential-existential group psychotherapy (incorporating cancer into one’s life) with that of a social-support group in regard to psychosocial adjustment (including psychological, psychosexual, and social adjustment); to examine the effect of age, type of surgery, and stage of disease on psychosocial adjustment indicators at the end of the intervention and at one year after the intervention

After the participants provided informed consent, they were randomly assigned to treatment groups: one group that received group psychotherapy; one group,  social support. Data were collected at baseline (T0), then the intervention groups were conducted for three months. Data were collected after the intervention (T1) and at 12 months after completion of the intervention (T2). The interventions consisted of 12 weekly sessions of 2.5 hours each, including a 30-minute coffee break. The two follow-up sessions were at one and two months after the close of the intervention groups. The two follow-up sessions involved only 6–10 women and were conducted by trained leaders. Two trained therapists led the experiential-existential groups, and two trained leaders led the social-support groups. The study method required at least one of the therapists or leaders in each group to be a woman. Each group psychotherapy session, except the 1st and the 12th, followed a specific structure: opening, discussion of a specific topic, choosing the topic for the following week, and closing the session. The first session focused on introduction of the procedures and getting to know others. The 12th session was used to evaluate the group, to discuss what was learned or missed, to suggest improvements, and to say goodbye. Participants were allowed to choose the topics of the two follow-up sessions.

• The sample was composed of 67 participants.
• Mean age of participants in each group was 49 years.
• All participants were female.
• Participants had breast cancer with no distant metastasis. No participant had a diagnosed psychiatric illness. In the psychotherapy group, 12 participants had had breast-conserving surgery; in the social-support group, 10. In the psychotherapy group, 21 had had mastectomy;  in the social-support group, 24.
• No significant demographic differences existed between intervention groups.
   

• Multisite
• Outpatient
• Several hospitals in Rotterdam, The Netherlands
   

• Phase of care: transition phase after initial treatment
• Clinical applications: late effects and survivorship
   

A time-series randomized clinical trial

• Emotional adjustment: Dutch version of the Profile of Mood States (POMS) scale   
• Psychosexual functioning: Sexual Functioning subscale of the European Organization for Research and Treatment quality of life questionnaire (EORTC QLQ-C30)
• Psychosexual functioning: Body Image subscale of the the EORTC QLQ-C30
• Social adjustment: Social Interaction subscale of the Sickness Impact Profile (SIP)
• Social adjustment: Recreation subscale of the SIP
• Demographic questionnaire
   

In regard to distress, vitality, sexual functioning, and social intentions, the psychotherapy group did not benefit more from the intervention than did the social-support group. At the end of the sessions, participants reported positive changes in regard to body image and recreation; the disease had less impact on recreational activities than on body image. Type of surgery was related to body image: Participants who had had breast-conserving surgery reported a more positive body image than did participants who had not.

Psychologically well-adjusted women diagnosed with breast cancer do not benefit from the interventions described in this study: experiential-existential group psychotherapy and social-support groups.

• The study has a small sample size, with fewer than 100 participants.
• The details of the therapies limit generalizability and raise questions regarding study replication.
• Decrease in the impact of disease on recreation could be a function of time.
• The drop-out rate seemed higher among participants who had had mastectomy than among those who had had breast-conserving surgery.
• Participants were psychosocially well adjusted at the beginning of the study, which may account for the minimal improvements shown.
• Only 27.5% of the women asked to participate in the study agreed to participate; 23% who began the study dropped out.
   

Results do not make clear whether support groups or group psychotherapy are beneficial for women who do not have substantial distress. In clinical practice, screening patients for psychological distress makes sense, as does providing therapy and the specified support interventions only to those patients who have distress and who may benefit.

To assess the effect of one-on-one peer support on enhancing self-efficacy and decreasing depression in men undergoing radical prostatectomy for prostate cancer

A core group of support partners who were prostate cancer survivors were recruited for the study protocol and trained to recognize signs and symptoms of clinical depression, communicate with active listening skills, and record reactions of study participants in a weekly log. One-on-one sessions were held in a private location, without involvement of patient's significant others. Men were randomly assigned to the support intervention or usual care. Support sessions were to be done eight times over an eight-week period. Data were collected at baseline and at four and eight weeks.

• The sample was composed of 72 participants.
• Mean patient age was 60 years, with an age range of 47–74 years.
• All participants were male.
• All participants had undergone prostatectomy at least six weeks prior to the study and had been diagnosed within three months of the study.
• Of participants in the intervention group, 80% were married; in the control group, 67.6% were married. Of all participants, 83% were white and 35% had at least a high school or technical school education.
   

• Single site
• Outpatient
• Florida, United States

• Phase of care: active antitumor treatment
• Clinical application: eldercare

Randomized controlled trial

• Geriatric Depression Scale
• Stanford Inventory of Cancer Patient Adjustment
• Modified Inventory of Socially Supportive Behaviors
• UCLA Prostate Cancer Index
   

The number of sessions was 1–8.  Those in the treatment group had significantly higher self-efficacy (p = 0.005) and lower depression (p = 0.032) at eight weeks. All patients had low depression scores at baseline. There was an 8.6% drop-out rate.

The support intervention provided by trained prostate cancer survivors demonstrated a positive effect on patient self-efficacy and depression scores.

• The study had a small sample size, with fewer than 100 participants.    
• The study shows baseline sample and group differences of import.
• The study had a risk of bias due to no appropriate attentional control condition.
• Findings are not generalizable because
  • The study was limited to specific prostate cancer patients. 
  • At baseline, between groups there were substantial differences in depression scores and urinary and sexual functioning.
  • A larger proportion of control patients were married, which could have contributed to greater concerns regarding impotency and relationships than might have occurred in the intervention group.

Study findings show a positive effect of one-on-one support among men with prostate cancer when support was provided by prostate cancer survivors who had the same treatments, side effects, and experiences. It has been suggested that men do not tend to participate in support groups, being less inclined to share concerns in a support-group setting. One-on-one pairing, one patient with one individual who has had similar experiences and adjusted well, may be very beneficial to patients.

To assess the effectiveness of a volunteer-delivered, tailored telephone-based intervention in reducing unmet supportive care needs and elevated levels of anxiety and depression among people with colorectal cancer

The intervention utilized a checklist of unmet needs that patients with colorectal cancer completed. Specially trained volunteers then followed up with patients, by means of telephone consultation, to review needs and devise an action plan.

• The study reported on a sample of 653 patients with colorectal cancer.
• Mean patient age was 64.57 years (SD = 9.2 years).
• The sample was 40.5% female and 59.5% male.
• Of sample patients, 78% were married; 49% had undergone chemotherapy, 89% had undergone surgery, and 10% had undergone radiotherapy; and almost 90% had at least a high school education.

• Outpatient setting
• Australia

Transition phase of care

Randomized controlled trial

• Supportive Care Need Survey (SCNS)
• Hospital Anxiety and Depression Scale (HADS)
• Nine-item colorectal cancer symptom checklist (developed for study)
• Eleven-item questionnaire on the use of supportive care services (developed for study)
• Medical Outcome Study Social Support Survey (MOS-SSS)

• The prevalence of elevated anxiety decreased over time in the intervention group (p < 0.01).
• Compared to the control group, the intervention group reported a greater use of services (p < 0.01).

This study suggests that a volunteer-delivered, telephone-based intervention is plausible and acceptable to patients with cancer and that the intervention was effective in getting patients to use available services. This approach was associated with reduced anxiety over time, but did not have an impact on depression or prevalence of unmet needs as identified by the patients.

• The study design lacked an attentional control.
• The study did not include discussion regarding supportive services utilized and whether they met patients’ unmet needs.
• The intervention was delivered to patients three to four months postdiagnosis, and the highest period of unmet needs may actually be sooner in the treatment trajectory.

Tailoring support and interventions to only those patients with unmet needs might be a better allocation of resources while producing significant results.