To determine if palifermin reduces severe oral mucositis (OM), defined as grade 3 or 4 on the World Health Organization (WHO) Oral Mucositis Grading Scale, in patients undergoing postoperative radiochemotherapy for locally advanced head and neck cancer

• This study had three arms. In arm 1, patients received 120 ug/kg palifermin per week during radiochemotherapy (at least seven doses). In arm 2, patients received 120 ug/kg palifermin per week for four doses, then placebo throughout the remainder of radiochemotherpy. In arm 3, patients received placebo throughout radiochemotherapy.
• Radiation therapy consisted of conventional or three-dimensional radiation planning for standard fractionation (5 X 2 Gy per week), for a total dose 60 Gy to 66 Gy. Chemotherapy consisted of 100 mg/m² cisplatin on days 1 and 22. Palifermin was administered once, three days prior to starting radiochemotherapy, followed by six once-weekly doses. 
• Local supportive care of normal saline rinses, topical anesthetics, feeding tube, and hematopoietic growth factors were allowed. Anti-inflammatory, antifungal, or antibiotic mouthwash solutions were not permitted.

• The study reported on 186 patients with a mean age of 56.5 years.
• The sample was 82% male and 18% female.
• Patients were resected for pathohistologically documented, high-risk Stage II to IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx and were expected to receive at least 50 Gy to at least two of the main areas of the oral or oropharyngeal mucosa.
• Patients had European Cooperative Oncology Group (ECOG) performance status of 0–2, no history of pancreatitis or acute pancreatitis within the last year, and no prior radiation to the head and neck region or prior to chemotherapy.

This was a multisite study conducted in Australia, Canada, France, Germany, Italy, Spain, and United Kingdom.

Patients were undergoing the active treatment phase of care.

This was a double-blind, randomized, placebo-controlled trial.

• The WHO oral toxicity scale was used.
• Trained evaluators conducted twice weekly assessments (at least 3±1 days apart throughout radiochemotherapy) until resolution of OM to WHO grade 2 or lower or until week 15.
• If OM was not resolved by week 15, weekly assessments were continued until OM reached grade 0 or 1 or until week 24.
• Evaluations immediately analyzed for data quality and accuracy by Clinical Assistance Programs.

• The four-arm palifermin arm was halted because of slow enrollment. Results for the 38 patients on this arm were analyzed separately and matched for the first 38 patients enrolled in the placebo arm.
• Palifermin at 120 ug/kg reduced severe OM in patients with head and neck cancer undergoing concomitant postoperative radiochemotherapy.
• Severe OM was observed in 47 (51%) in the palifermin arm and 63 (67%) in the placebo arm (p = 0.027). The median durations of severe OM were 4.5 days in the palifermin arm and 22.0 days in the placebo arm (p = 0.037). The median times to develop severe OM were 45 or 21 days (p = 0.022) in the palifermin and placeblo arms, respectively.

Palifermin administered prior to initiation of and weekly during concurrent chemotherapy-radiation therapy reduced OM incidence. The study also examined secondary endpoints (i.e., duration and onset, xerostomia, mouth and throat soreness (MTS) score) as well as radiation treatment breaks and chemotherapy delays. Patients receiving palifermin did not experience fewer breaks or lower average MTS  even though these patients did receive fewer opiod analgesics.

This study was supported by Amgen, which manufactures paliferrmin.

Treatment-related OM is debilitating for patients with head and neck cancer undergoing concurrent chemotherapy-radiation therapy. This can significantly impact patient comfort, nutritional status, and response to therapy. Further research is needed to identify effective therapies to better protect the oral mucosa.

To formally evaluate whether a tailored and experiential training approach by an experienced nurse would enhance confidence (self-efficacy) of family cancer caregivers to provide home care and manage patients’ symptoms of illness

The study principal investigator (PI) provided a conceptually based, tailored, and patient-centered bedside intervention for family caregivers providing home care to patients with hematologic malignancies. Caregiver training included symptom management on prevention of infection, pain, poor nutrition, constipation/diarrhea, and management of medications for patient cancer symptoms. Interactive discussion on these topics occurred between interventionist (experienced nurse), caregiver, and patient. To encourage patient involvement in problem-solving symptoms, dyad participation was also incorporated into bedside training. Caregivers received an illustrated take-home manual on discussed topics. Discussion focused on nonpharmacologic interventions to improve patient comfort and meet other patient needs. Caregivers provided a return demonstration following nurse delivery of didactic teaching and skill performance (e.g., catheter care management) specific to patients’ home situation. Sufficient time was provided in the teaching encounter for patients and caregivers to ask questions and to allow satisfactory completion of the skills required for effective patient home care before patient discharge.

Assessment of the influence of the intervention occurred before and after PI training and one week following hospital discharge of the patients. Caregivers completed postintervention assessment within 24 hours of the PI’s didactic and skill performance presentation to caregivers.

• The sample (N = 16) was 15% male and 85% female.
• Sample age range was 44–80 years.
• Mean age was 62 years for both patients and caregivers.
• All patients had hematologic cancers and were admitted for chemotherapy or treatment of cancer-related acute conditions.
• Caregivers were connected to patients who were likely to be discharged soon and who were not actively dying; lived with patients in the same home and served as primary caregivers; and were English speaking and reading.
• The majority of caregivers were white and did not work outside the home; almost half were educated at the associate degree level or higher.

• Single site
• Multiple settings
• Southeastern U.S. regional medical center

Active antitumor treatment phase

A quasi-experimental, time-series design was used.

• Cancer Caregiver Self-Efficacy (Confidence) Questionnaire (CCSE): This 23-item tool was used three times in the study to assess caregiver confidence in completing a behavioral task or skill.
• No prestudy reliability and validity indices were reported.
• Cronbach’s alpha was 0.94 for the CCSE. Construct validity index of 0.77 (p < 0.001) was reported for the CCSE when the scores from the study sample of 16 were correlated with historical data including the Caregiving Preparedness Scale.

Total caregiver CCSE scores were significantly higher immediately after caregiver training (z = 4.49, p < 0.001) and one week after hospital discharge of patients (z = 3.22, p < 0.001). These higher scores reflect higher and some sustained levels of caregiver confidence to provide needed home care to patients comprising the sample. Although unanticipated, four patients died within one week of hospital discharge (20% attrition for study), producing a total sample of 16 from the initial sample of 20 patient–caregiver dyads for the one-week assessment.

Timely assessment and nurse-led interventions relevant to assessment findings may increase caregiver confidence to assume home care for patients with hematologic malignancies. Based on Bandura’s (1986) conceptual self-efficacy framework, this pilot study suggests that nurse-led individualized teaching and modeling of homecare skills at the patient’s bedside prior to discharge can sustain caregiver confidence for up to one week postdischarge of the patient. Caregivers and patients believed the intervention to be highly beneficial based on a 1:1 relationship with the nurse-teacher.

• The sample was small, with less than 30 participants.    
• Risk of bias existed because of no control group, no blinding, and no appropriate attentional control condition.
• Unintended interventions or applicable interventions that would influence results are not described.
• Findings are not generalizable.
• Subject withdrawals were greater than 10%.
• Involvement of the PI or study staff with the rounding oncologist during prerecruitment may have influenced individuals approached for the study (Were those with greatest needs referred for the study?)
• The acuity level of the sample patients and the functional health of caregivers to support their ability to provide home care are unknown.
• Whether training occurred the day of discharge or how variable the timing and length of the intervention was are unclear.
• Whether data from the 20 subjects were used in the pre- and post-analysis and then from the 16 for the pre-one week, or whether the 16 were used for all analysis, is unclear. The analysis section suggests that a mixed-effects model was used, suggesting that all data were used and missing data were modeled. More manuscript details would aid in interpretation of the study findings.
• Threats of maturation and selection also may affect internal validity of the study.

As part of their education, nurses learn about the teaching-learning process to optimally prepare patients, families, and communities about ways to improve personal and societal health. With early discharge of patients and the need for family members to often assume complex caregiving roles, there is a heightened need for nurses to use their knowledge of teaching-learning to assess and implement effective teaching to families during the cancer trajectory. Individualized and bedside teaching approaches, such as those found in this study, benefit patients and family members in both inpatient and outpatient settings. Study findings must be evaluated with caution due to the small sample size, one setting for data collection, and lack of control group. More specifically relative to sample size, additional replication of the study must occur to more clearly identify the influence of the individualized and experiential training program on diverse population groups related to ethnicity, clinic care type, education level, and gender (external validity). This would capture deeper understanding of needed components of tailored care in the healthcare team approach to efficiently meet caregiver and patient needs.

To examine the effects of enhanced training on caregivers’ self-efficacy in managing patients' symptoms, stress, preparedness for caregiving, depression, and anxiety

Researchers structured and used enhanced caregiver training (CT) that taught caregivers how to manage patients’ symptoms and their own stress. This training added distress management to previously developed training that focused on managing patients' symptoms only. Training was done at the patients' bedside, one on one, with dyads (patients and their caregivers), and required one to two hours. Training on symptom management involved a manual process that started with a needs assessment to tailor the training to the patient’s situation, an interactive discussion that involved both the patient and the caregiver about how to manage symptoms, and concluded with a one-page hand out on each symptom. Training related to caregivers’ stress management involved a three-step behavioral rehearsal procedure. The nurse modeled how to implement the skill, and the caregiver practiced the skill and received constructive feedback. Finally, the caregiver practiced until she or he mastered the skill.

• N = 38 (intervention); 38 (control)
• AVERAGE AGE = 55 years (caregivers)
• MALES: 18%, FEMALES: 82%
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of caregivers were adults, Caucasian, married, had at least some college education, and were the spouses of patients. The majority had a high level of health literacy, and the average length of caregiving was 19 months. A dyad was excluded if a patient was under hospice care.

• SITE: Single site    
• SETTING TYPE: Inpatient  
• LOCATION: Duke University Health System Oncology Units

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

Randomized, controlled trial in which the intervention arm received enhanced CT and the control group received information about community resources

• Modified Caregiver Self-Efficacy Scale (CaSES) to assess confidence in caregiving abilities (13 items) and in stress management (one item)
• The Preparedness for Caregiving Scale (PCS), a subscale of the Family Caregiving Inventory (FCI)
• Profile of Mood States (POMS) to assess anxiety
• Center for Epidemiologic Studies–Depression (CES-D) scale
• Caregiver Reaction Assessment (CRA) to assess caregiver burden
• Rapid Estimate of Adult Literacy in Medicine (REALM-R) to assess health literacy

Significant difference was identified between the intervention and control groups in self-efficacy for managing patients' symptoms, caregiver stress, preparedness for caregiving immediately after the intervention. The intervention group scored higher on the previous outcomes. No differences in other outcomes were found, and the differences initially observed after the intervention were not sustained at two and four weeks after discharge.

Enhanced CT improved caregivers’ self-efficacy, stress management, and preparedness for caregiving immediately after the intervention. However, it did not lead to significant changes in anxiety, depression, or burden. No sustained effects of the intervention were observed for any outcomes.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: This was a well done trial despite the identified limitations.

Caregiver training given in a single dose may not be the best approach to improving caregiver outcomes. Training or interventions for caregivers should be tailored based on emerging needs after discharge, and they should not be exclusively based on the observed or anticipated needs prior to a patient's discharge from the hospital.

To (a) investigate the effects of an individualized caregiver training intervention on a caregiver’s self-efficacy in home care and symptom management, and (b) identify whether caregiver training would affect a caregiver’s psychological well-being (depression, anxiety, and quality of life)

After signing informed consent, dyads completed baseline questionnaires and were randomly assigned to either a treatment group or a control group. Interactive nurse–caregiver training for one to two sessions was offered when discharge was imminent. Immediately after caregiver training, caregivers completed questionnaires on self-efficacy. Follow-up questionnaires for caregivers and patients were completed at one week, two weeks, and four weeks after hospital discharge of patients.

The caregiver training intervention provided caregiver training for managing patients’ cancer symptoms with four major components: (a) prevention of infection, (b) pain control, (c) maintenance of nutrition, and (d) adequate elimination. The program was manualized, including a book for caregivers with “how to” pictures. Additional time and content were allocated to address specific homecare issues identified by caregivers. The training followed a consistent outline, but information shared was specific to needs of the patient and caregiver.

The control intervention consisted of an interactive nurse–caregiver standardized, manualized one-two session intervention focused on information about community resources for caregiving. This included but was not limited to home health agencies, respite care, and caregiver support services.

• The sample included 120 patient dyads (60 in treatment group and 60 in control group).
• Of the caregivers, 48% were 46–64 years of age; of the patients, 54% were 60–69 years of age.
• The caregiver sample was 17% male and 83% female; the patient sample was 71% male and 29% female.
• Patients had hematologic malignancies.
• Of the caregivers, 84% were white, 89% were married, 60% had education beyond high school, 64.6% were not working outside the home, and the patient for whom they cared was a spouse.
• Of the patients, more than 80% were white, 88% were married, and almost 90% had education beyond high school.

• Single site
• Outpatient setting
• Duke University Hospital in Durham, NC

• Multiple phases
• Home care; after hospital discharge; survivorship

A randomized controlled trial design was used.

• Lorig’s Self-Efficacy Scale: Noted prior assessed reliability (0.94) and validity
• Hospital Anxiety and Depression Scale (HADS): No noted prior reliability and validity
• Older Americans Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire (Instrumental and Physical subscales): No noted reliability and validity
• OARS Comorbidity Scale: No noted reliability and validity indices
• Caregiver Quality of Life–Cancer Scale (CQOLC): Noted earlier assessed internal consistency of 0.91   
• Memorial Symptom Assessment Scale (MSAS): No noted reliability and validity

There was increased self-efficacy immediately following the caregiver training intervention and higher self-efficacy and symptom management at four weeks after the intervention when compared to the control group. A significant group-by-time interaction (p = 0.008) was present in the training intervention caregiver group that showed decreased depression scores from baseline to time 3 (one week). However, significant differences between treatment and control groups were not found after time 3. A similar result occurred when analyzing the effect of the intervention on caregiver anxiety. In terms of the effect of the caregiver intervention on patient’s physical symptoms, the overall intervention over time did not significantly improve symptoms. There was also no significant effect of the intervention on caregiver quality-of-life scores in both the control and caregiver training groups.

Caregivers have a major role in the outcome of a successful transition from hospital to home. This study provides information about caregiver training that improved their self-efficacy when addressing symptom management of a family member with cancer. More research is needed to determine the most effective caregiver training to manage patients’ symptoms at home.

• Nurses delivering the caregiver training intervention and the control intervention were not blinded.
• Assessment of the delivery of control and caregiver training intervention did not occur.
• The sample was mostly white, educated, and married.
• Caregivers were not observed providing actual home care and symptom management interventions.

Caregiver training for the patient’s home care and symptom management is critical in bridging the transition for patients from hospital to outpatient care. Nurses play a key role in this caregiver training tailored to specific caregiver and patient needs. Evidence-based information about the most effective training, including decisions about frequency, dosing, timing, formatting of information, and preparation of the nurse, is needed to improve caregiver quality of life and psychological well-being.

STUDY PURPOSE: To assess the evidence of effectiveness of these agents on bone pain and quality of life (QOL)

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 25 
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,044 with bisphosphonates or denosumab, 762 with radioisotopes
• SAMPLE RANGE ACROSS STUDIES: 22–1,597 patients
• KEY SAMPLE CHARACTERISTICS: Multiple tumor types, including lung cancer

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care

Thirteen studies examined use of bisphosphonates and/or denosumab. Twelve studies used various radioisotopes. No randomized studies using bone-modifying agents were found. One randomized study compared zoledronic acid versus ibandronate. Most of these studies were examining effects to prevent skeletal events. Overall for those with NSCLC, a mean of 67% of patients had a decrease in pain score (3 studies, 225 patients). Of patients given samarium, 60%-95% experienced a decrease in pain. Overall radioisotopes appeared to reduce pain with rapid onset, lasting one to three months. Data were limited for individuals specifically with NSCLC. Most studies did not include QOL measurement; in the five studies that did, only two showed improvement.

Limited evidence exists that bisphosphonates or denosumab reduce or prevent pain from bone metastases or impact QOL in patients with NSCLC . Radioisotopes appear to have a palliative effect on pain, but no high-level evidence for this was found.

• No quality evaluation

Although some evidence exists that bone-modifying agents prescribed to prevent skeletal events may reduce associated pain, the evidence is limited, particularly for patients with NCSLC. Radioisotopes appear to reduce pain for a limited amount of time, and repeated use can have significant adverse effects on bone marrow. Authors of this report suggest that efficacy for pain relief may be tumor dependent, and that, due to potential bone marrow suppression, radioisotopes should be reserved for patients who are not receiving active anticancer therapy and pain that is not appropriate for palliative radiotherapy.

To evaluate the effectiveness of topical silver sulfadiazine to prevent radiation dermatitis in women receiving radiotherapy for breast cancer

Patients were randomized to intervention and control groups and were matched by the investigator in terms of the flatness of the chest wall. Patients in the intervention group were instructed to apply 1% silver sulfadiazine cream to the irradiated field every eight hours for three consecutive days. No application was done on the days they received radiation therapy. Use of the cream was continued for one week after completion of radiotherapy. Both groups were educated in general skin care. No other creams were to be applied to the radiation field. Skin in the field was examined weekly by a random radiation oncologist who was not informed of patient group assignment.

• The study sample was comprised of 102 female patients with breast cancer.
• Mean age was 48.4 years.
• Chemotherapy had to be completed at least three weeks prior to study entry.  

The study took place in an outpatient setting in Iran.

Patients were undergoing active antitumor treatment.

The study used a single blind randomized controlled trial design.

The Radiation Therapy Oncology Group scoring of skin toxicity was used.

 From the second week onward, patients who received the silver sulfadiazine cream showed lower grades of skin injury (p < 0.002).

Silver sulfadiazine was more effective than no treatment in reducing the severity of radiation-induced dermatitis.

• The study had a risk of bias due to no blinding.
• Measurement validityand reliability are questionable.
• Patient adherence to use was not evaluated. 

Silver sulfadiazine was more effective than no skin treatment to reduce severity of radiation-induced dermatitis. It would be more helpful to determine the difference between this approach and other topical treatments, which have been shown to have some efficacy.

To assess the efficacy of continuous infusion pump delivery of bupivacaine at TRAM flap donor site; to assess the safety of continuous infusion pump delivery of bupivacaine at TRAM flap donor site

Patients received 0.375% bupivacaine or isotonic saline through a continuous infusion pump in the suprapubic area and caudal to the donor site incision. All patients received narcotic via PCA programmed for demand-only mode, with no basal rate. Patients could receive oral narcotics. Pain at rest was evaluated four times per day while patients were awake. Overall satisfaction was assessed every four hours for the first three days.

• The sample was composed of 48 patients, 23 in the intervention group and 25 in the control group.
• In the intervention group, mean patient age was 50.3 years; in the control group, 47.6 years.
• All participants were female.
• All participants were undergoing unilateral mastectomy with TRAM flap reconstruction.

• Single site
• Inpatient
• M.D. Anderson Cancer Center, Houston, Texas

Prospective randomized, double-blinded trial

• Amount of PCA narcotic used
• Type and amount of oral narcotic used
• Pain score, on a 10-point visual analog scale (VAS), measured four times daily when patient was at rest
• Patient satisfaction as measured every four hours for three days

• During the first two postoperative days, total PCA use was lower in the continuous infusion group than in the control group. (In both groups, measures of the intensity of abdominal pain at rest reflected significantly lower pain with each postoperative day. Measures were not significantly different between groups.)
• Patient satisfaction was higher in the continuous infusion versus the control group (P = 0.032).

Continuously infused bupivacaine reduced patients' need for PCA opioids early in the postoperative period.

• Pain from the mastectomy site may have been a confounding factor.
• The study had a small sample size, with fewer than 100 patients.
• Limitations may include individual differences regarding pain perception, pain threshold, and the appropriateness of requests for pain medication.

Postoperative mastectomy-TRAM patients may benefit from continuous infusion of anesthetic to an operative site. Ongoing research to determine the most effective dosage and the most effective anesthetics is warranted.

Patients were randomized to one of two arms.

• Arm A was given topical granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leucomax) mouthwash three times per day. The mouthwash consisted of 400 mcg GM-CSF in 250 mL water. Patients were instructed to rinse with 25 mL for 3 minutes and repeat 10 times within 30 minutes. They were to repeat this process at three identical times each day.
• Arm B was given a solution of 4 mL povidone-iodine in 125 ml water with amphotericin B. They were to rinse with 10 mg four times per day according to the same instructions as Arm A.

Both groups were instructed to continue using the respective mouthwashes until complete response (CR). A third, independent investigator randomized patients without knowing individual mucositis ratings.

• The study reported on 31 patients, with 15 in Arm A and 16 in Arm B.
• Patients' ages ranged from 39–77 years, with a median age of 58 years.
• All patients had solid tumor diagnoses.
• The World Health Organization (WHO) oral mucositis scale was used to grade patients after they had received fluorouracil (5FU)-based chemotherapy. Two investigators independently rated mucositis severity.

The study was conducted between March 1998 and June 1999.

This was a prospective, randomized, controlled study.

Every three days, objective and subjective evaluations were conducted.

• Patients who received the GM-CSF treatment experienced shorter duration (5.3 versus 8.1 [p = 0.0008]) and quicker resolution (2.8 versus 4.1 [p = 0.0011]) of mucositis.
• No side effects were reported, and the treatment was well tolerated.

• The sample size was small.
• Application of mouthwash findings is complicated.
• The treatment has a high cost.

To investigate the short- and long-term effects of a psychosocial side-by-side couple's intervention on disease distress, post-traumatic growth, communication, and dyadic coping among women with breast and gynecologic cancers and their partners

The side-by-side intervention consisted of four meeting sessions between a participating couple and a therapist on a biweekly, face-to-face basis at the couple’s home. Each meeting session lasted two hours. Each of the four sessions focused on a certain theme and had specific objectives.

The Couples Control Program was the control group. Control group couples received only one two-hour session where they were given written educational materials about breast and gynecological cancers. The therapist used a structured protocol when interacting with participants.

• The sample included 72 participants.
• Age range of participants was 25–80 years, with a median age of 52 for the combined sample of women and their partners.
• Males (partners) represented 50% of the sample; mean age of partners (all men) was 52.2 years (SD = 11.3).
• The study involved women with breast or gynecologic cancers and their partners. Patients’ treatments for their disease included surgery (90%), radiation therapy (72%), chemotherapy (69%), and hormone therapy (60%).
• There were significant differences between groups for cancer-specific distress (F (1,71) = 6.2, p = 0.02) and fear of progression (F (1,71) = 8.6, p = 0.005) at pretesting.

• Multisite
• Outpatient setting
• Couples were recruited in three regional hospitals in Germany.

Active antitumor treatment phase

 A two-site, controlled, parallel-group study with random assignment (balanced randomization [1:1]) was used.

Psychosocial distress:

• Questionnaire on Stress in Cancer Patients (QSC-R23) was used to assess cancer-specific distress. This questionnaire was given to the women only (patients). Internal reliability was good (alpha 0.87).
• Fear of Progression Questionnaire (FoP-Q) was used to assess fear of cancer progression in both the women and their partners. Internal reliability was good (alpha 0.87).
• Avoidance-Defense Scale, which is a subscale of the Dealing With Illness Inventory–Revised, assessed how much women and their partners used avoidant behaviors in dealing with the disease. Internal consistency was alpha 0.54 and 0.51 for women and men, respectively.

Benefit finding:

• Post-Traumatic Growth Inventory was used to assess an individual finding meaning and benefit from the experience of severe life events; this inventory was done for women and their partners.  Reliability was good (alpha 0.92 and 0.91 for women and men, respectively).

Relationship satisfaction:

• Quality of Marriage Index (QMI) was used to assess marital satisfaction for women and their partners. Reliability was good (alpha 0.95).

Communication:

• Communication subscale of the Partnership Questionnaire was used to assess communication quality for both women and their partners. Reliability was good (alpha 0.86 and 0.82 for women and men, respectively).

Dyadic coping:

• Dyadic Coping Inventory was used to assess how partners cope with stress in their relationship; they report on their own behavior, their perceived partner’s behaviors, and their perceived behavior on themselves as a couple. This was measured for women and their partners. Reliability was not reported.

Sample description and differences:

• Baseline data showed that women in both groups (intervention and control) were somewhat distressed and that both men and women showed high average dyadic coping at baseline in both groups. Furthermore, participants in the intervention group showed significantly higher levels of fear of disease progression than their control group counterparts (M = 39 [SD = 9.2] versus M = 32.8 [SD = 8.6], F (1, 71) = 8.6, p =0.005).
• The only significant difference between groups was in their continuation with the long-term assessments at 12-month assessment: More couples dropped from the control group (45%) compared with the intervention group (17%) X² (df) = 1) = 6.7, p < 0.001. In addition, women who dropped in the control group after the post-treatment had lower communication quality (M = 16 [SD = 3.6]) at baseline than those who continued in the study (M = 19.9 [SD = 4.9], F (1, 25) = 4.6, p = 0.04.  

The following changes were observed in the outcome variables:

• Women in the intervention group showed less avoidant behavior over time compared to women in the control group who showed an increase in avoidant behavior. The interaction between intervention, time, and gender was a significant predictor t (395) = 2.56, p = 0.011 (β = 0.31 [SD=0.12]). Males in the intervention group had an increase in avoidance from pre to first follow-up (third assessment ), whereas males in the control group maintained a high level of avoidance across time.
• Couples in the intervention group showed a higher level of dyadic coping at all assessments (pre, post, follow-up 1, and follow-up 2), whereas couples in the control group showed decline across post through follow-up 1, with an increase in dyadic coping at follow-up 2.

Side-by-side intervention showed clear benefit compared to the control group in fear of disease progression and avoidant behavior. This benefit was short-term and did not carry through to long-term assessments. There was also clear benefit in dyadic coping and communication, but both were also short-term. 

Side-by-side intervention has shown potential benefit in faster post-traumatic growth compared to control group.

• The sample was small, with less than 100 participants.
• There were baseline sample/group differences of import.
• The study had risk of bias due to no blinding and no random assignment, as well as the sample characteristics.*
• The intervention was expensive, impractical, and/or required training needs.*
• Subject withdrawals were 10% or higher.
• Other limitations/*explanation: The study was too complex to be readily comprehensible. Based on the descriptions in the study, it is not clear when the different sessions of intervention occurred, and the timeline was confusing. The reporting was too detailed and presented in a way that loses the reader in the detail. The study design required assessments over time (about 16 months), which leads to attrition challenges. The attrition affected, and possibly contributed to, some bias in the results. The study was thorough but also a case where too much was done. In short, the study was far from parsimony.

The findings indirectly indicate that the interdisciplinary team caring for women with cancer should involve the services of psychologists, family therapists, or advanced practice nurses with specialized training in mental and relationship wellness for patients and their partners.

Nursing care should include an assessment of a couple's distress level and communication patterns over the trajectory of a breast or gynecologic cancer illness.  

Attrition and recruitment in long-term studies involving caregivers remain serious threats, and future research designs and methodologies should include clear plans to manage these challenging aspects.

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.