To update evidence from randomized controlled trials (RCTs) regarding benefits of conservative and dietary interventions for all cancer-related lymphedema

Databases searched were MEDLINE, EMBASE, CINAHL, PubMed, Dissertation Abstracts, PEDro, and Cochrane Collaboration. Keywords were neoplasm, axillary dissection lymph node excision, lymphedema, conservative treatments (e.g., stockings compression, manual drainage), and publication types of random allocation and clinical trial. Studies were included in the review if they were RCTs with a sample of at least 80% patients with cancer comparing a conservative or dietary intervention to placebo, control, or comparison intervention in secondary lymphedema from cancer. Exclusion criteria were not specified.

Of the 157 papers that were initially retrieved, a final set of 25 were included. A modified Jadad scoring was used to evaluated the quality of the evidence. Only eight studies met criteria for high quality. Meta-analysis was done for studies examining the effect of manual lymph drainage (MLD)for upper-extremity lymphedema with breast cancer.

• The final sample of 25 papers involved 1,018 participants.
• Study sample sizes ranged from 11–90.
• Of the 25 papers, 21 were in patients with breast cancer.

Results were synthesized in terms of effects on lymphedema volume and patient-rated outcomes of pain, heaviness, tenderness and quality of life for nine interventions. Most studies were limited to upper extremities; where lower extremities were included is stated below.

• Strong evidence from three studies on exercise showed neutral impact on volume and benefit in symptoms and quality of life with upper extremities.
• There was moderate evidence from one study on compression bandaging for lower- and upper-extremity volume reduction and no evidence related to symptoms
• Compression Garments
• Moderate evidence found volume reduction for upper and lower extremities with compression garments. No evidence was found related to symptoms.
• Three studies had no evidence of benefit of MLD for symptoms; volume of lymphedema was not reported.
• One study showed moderate benefit related to short-term volume for deep mechanical oscillation with MLD and moderate evidence of benefit for symptoms in the short term but not at follow up.
• One study showed no evidence of any benefits from mechanically stimulated MLD.
• One study showed limited short-term benefit in lymphedema volume, but no evidence of benefit for symptoms with dietary modification.
• Four studies showed limited evidence of benefit in the short and long term for laser therapy ,and three showed limited evidence for benefit related to pain.
• One study provided no evidence of benefit from electrically-stimulated lymphatic drainage
• Four studies provided conflicting evidence, with two showing benefit in volume and two showing no benefit from intermittent pneumatic compression.
• Meta-analysis results found five studies including 198 cases examined the addition of MLD to compression therapy alone or compression therapy along with other interventions. 
• Analysis showed that the addition of MLD was beneficial (SD = 0.37, 95% CI 0.07–0.67, p = 0.02)

Meta-analysis demonstrated significant but relatively small benefit from the addition of MLS in patients with breast cancer-related lymphedema. Findings support the growing body of evidence that participation in exercise does not exacerbate lymphedema and can reduce the severity of symptoms. Only two studies were found that examined nutrition and dietary interventions; these reported benefit in terms of volume reduction, but were of relatively low quality. Evidence suggests that compression garments and bandaging are effective in reducing limb volume with various types of cancer.

Only eight studies in this review were deemed to be of high quality.

Inclusion of MLD provides a relatively small added benefit and may be associated with substantial costs. It is not clear if the benefits outweigh the cost and MLD may be most useful for patients who do not achieve sufficient improvement with other effective approaches. Findings related to dietary interventions are promising, pointing to the value of additional research in this area. Breast cancer continues to be the most frequently studied group. Research in other groups and with lower-limb lymphedema is needed.
 

To examine the evidence of effectiveness from randomized controlled trials involving exercise interventions for preventing, minimizing, and improving upper-limb dysfunction because of breast cancer treatment

Databases searched were Specialised Register of the Cochrane Breast Cancer Group, MEDLINE, EMBASE, CINAHL, and LILACS (to August 2008). Experts, hand-searched reference lists, conference proceedings, clinical practice guidelines and other unpublished literature sources were also considered. Search keywords were neoplasm, tumor, tumour, mastectomy, axillary dissection, sentinel node dissection, adhesive capsulitis, cording, axillary web syndrome, physical therapy, physiotherapy, rehabilitation, exercise, stretching, mobilization, physical activity, exertion, range of motion, strength, lymphedema, pain, and quality of life. Studies were included if they were randomized controlled trials evaluating the effectiveness and safety of exercise for upper-limb dysfunction. Studies were excluded if they included cancers other than breast cancer (e.g., melanoma) unless separate data were available for a breast cancer subgroup.
 

The total number of studies reviewed initially was 82. Two authors independently performed the data abstraction. One author performed the initial pre-screen of all the databases to identify potential trials and screened the results to exclude articles that were clearly irrelevant. Two independent authors screened the reduced search results. If either or both authors felt that the article potentially met the inclusion criteria, or if there was inadequate information to make a decision, full-text copies of the article were retrieved. Using the defined eligibility criteria, the two authors independently decided on trial inclusion. A priori, authors made the decision to exclude any data that were available only in abstract form. Review authors were not blinded to study authors, journal, or study results. Agreement was measured and assessed using kappa statistics. Three investigators independently assessed quality of the trials and extracted data independently using a standardized form. Investigators were contacted for missing data.
 

• The total number of studies included was 24.
• The sample size across studies was 2,132, with a range of 21–344.
• Patients were women with lymphedema after breast caner treatment.
• Mean age of patients ranged from 46.3–62.1 years.

Exercise can result in a significant and clinically meaningful improvement in shoulder ROM in women with breast cancer. There is evidence that patients benefit from exercise interventions that include more structured instruction and supervision when compared to exercise instruction through a pamphlet or no exercise instruction. Of note, larger benefits were found for shoulder range of motion and shoulder function outcomes from physical therapy treatment that was introduced in the early weeks following surgery. There was no evidence of a negative effect from upper-extremity exercise on the incidence of upper-limb lymphedema at any time point following surgery.

In the postoperative period, consideration should be given to early implementation of exercises, although this approach may need to be carefully weighed against the potential for increases in wound drainage volume and duration. High-quality research studies that closely monitor exercise prescription factors (e.g., intensity) and address persistent upper-limb dysfunction are needed.

To examine the effects of progressive resistance exercise training on upper extremity pain and dysfunction in postsurgical head and neck cancer survivors

Participants were randomly assigned to either standard therapeutic exercise or progressive resistance exercise training (PRET). All were asked to attend at least two supervised sessions per week for 12 weeks. Standard exercise involved active and passive range of motion and stretching, postural exercise, and strengthening with light weights (1–5 kg) and elastic resistance bands targeting specific muscle groups. The PRET group received the same exercises except that the strengthening was replaced with individualized exercise on the same muscle groups designed with the intent to provide progressive overload to those muscles. Outcomes were assessed at baseline and postintervention.

• The study reported on 52 head and neck cancer survivors.
• Mean participant age was 52 years (range = 32–76 years).
• The sample was 71% male and 29% female.
• To be eligible, participants had to have undergone surgical treatment, including radical neck dissection, modified radical neck dissection, or other variants of selective neck dissection; have a Karnofsky Performance Status score greater than 60%; have no evidence of residual cancer in the neck and no distant metastases; and have completed adjuvant treatment for head and neck cancer.
• All participants were required to present with symptoms of shoulder dysfunction attributed to spinal accessory nerve damage.

• Multisite
• Outpatient setting
• Cross Cancer Institute and University of Alberta in Edmonton, Canada

The study was a prospective randomized controlled trial.

• A block permutation procedure to generate the allocation sequence with each stratum Borg scale for rating of perceived exertion
• Training log
• Shoulder Pain and Disability Index (SPADI)
• Functional Assessment of Cancer Therapy–Anemia (FACT-An) scale for quality-of-life and fatigue assessment
• Neck Dissection Impairment Index (NDII)

The PRET program significantly reduced shoulder pain and disability (p = 0.001) and improved upper extremity muscular strength and endurance. Patients participating in the PRET program had a 52% reduction in pain. The effect size for change in pain was d = 0.84. PRET was better than the standard exercise for all strength endpoints measured, and endurance was more improved with PRET (p = 0.039).

Findings show that a program of individualized progressive resistance exercise in patients with specific shoulder dysfunction postsurgery for head and neck cancer as provided here can reduce pain and disability.

• Range of time from surgery varied widely among participants.
• Study results may have been limited by long-term survivors with deficits refractory to the exercise protocol that focused primarily on active and passive range-of-motion and basic strengthening exercises.
• The study did not differentiate between the location and type of pain in participants, nor did it differentiate involvement of the upper, middle, and lower trapezius, which may affect head and neck cancer survivors’ clinical presentation and response to treatment.

Survivors of head and neck cancer can be burdened with pain and loss of strength and function associated with damage to the spinal accessory nerve. It is important that nurses consider means that will help to minimize these residual effects. Exercise is a noninvasive tool that enables patients to actively participate in their recovery. This study shows that a PRET program had a beneficial effect, with reduction in pain of 52% in the PRET group. Improvement in pain was also associated with increases in upper extremity strength and endurance.

To compare the reduction in arm lymphedema volume achieved from manual lymphatic drainage (MLD) in combination with compression bandaging (CB) to that achieved by CB alone

All subjects receive four weeks of allocated treatment, which also included standard education on proper arm and skin care. The MLD and CB group received 45 minutes of daily MLD Monday through Friday each week. Both groups receive CB.

Patients were included in the study if they

• Were female
• Had a breast cancer diagnosis
• Previously had unilateral surgery with axillary node dissection
• Were diagnosed with lymphedema
• Had not received treatment for lymphedema within six months prior to study.

Patients were excluded from the study if they

• Had distant metastases or local recurrence
• Were at the time receiving treatment with chemotherapy or radiotherapy
• Had any sign of infection in affected limb
• Had contraindications to intervention therapy.

The study took plact at the Cross Cancer Center in Edmonton, Canada.

The study used a prospective, randomized controlled study design.

• Water displacement volumetric and calculated volume determined from measurement of circumference were used to assess lymphedema volume.
• The primary outcome was the volume of lymphedema in the affected arm.
• Each person’s unaffected arm served as a control.
• Change score was represented by difference in volumes from the initial measurement to the final measurement at the end of four weeks.
• Data were analyzed comparing baseline characteristics using independent samples t-tests for continuous data and Pearson’s chi-squared test for categorical data.
• Outcome data was analyzed using the independent samples t-tests to compare changes between groups in outcomes from baseline to post-intervention.
• The rate of reduction was analyzed using a two-way analysis of variance repeated measures.
• Alpha level was set at p < 0.05.

A total of 45 participants completed the study. A significant reduction in lymphedema volume was found over a four-week period for both groups. No significant difference was noted in volume reduction (p = 0.812) or percent reduction (p = 0.297) between the groups. Therefore, a reduction in lymphedema volume occurred over the time period irrespective of the treatment group. The findings from the calculated volume determined from circumference measurements were consistent with the water displacement findings.

Findings suggest that CB alone should be considered as a primary treatment option in reducing lymphedema arm volume. It also suggests that treatment of lymphedema should be implemented as soon as possible after onset of the condition when treatment is likely to be more effective.

• Treatment on lymphedema volume over a one-month period with no further follow-up.
• Upper-extremity range of motion was not assessed.
• The study did not assess of effects of treatment on pain, function, body image, and quality of life.
• Staff that is knowledgeable in the application of CB is required for the intervention.
• Therapists certified in MLD are required.
• Staff must be trained and certified.
• CBs can be costly.

Databases seached were MEDLINE, CINAHL, EMBASE, PsycINFO, CANCERLIT, Cochrane Library, PEDro, and SPORTDiscus through March 2005.

Fourteen randomized trials were included. Nonrandomized trials, pilot studies, and studies reported only in abstract form were excluded. Therapeutic exercise regimens addressing only specific impairments to shoulder and arm were not included. Studies with an additional treatment arm or combined intervention (e.g., exercise with diet modification) were included only if the effects of exercise could be isolated. Studies were required to have quality of life, cardiorespiratory fitness, or physical functioning as a primary outcome. Secondary outcomes of interest included symptoms of fatigue, body composition, and adverse events resulting from the exercise intervention. Methodologic quality of each included study was evaluated using eight quality criteria specified a priori.

Outcomes were quality of life, cardiorespiratory fitness, physical functioning, symptoms of fatigue, body composition, and adverse events resulting from the exercise intervention.

There was wide variability in the exercise interventions evaluated. Interventions included Tai Chi Chuan, aerobic exercise (walking, cycle ergometer, and arm ergometer), resistance training (weights and resistance bands), and mixed aerobic and resistance exercise. Exercise programs were of moderate or low intensity, and the interventions included a mixture of supervised and self-directed programs, delivered individually or in groups. Overall, study reports provided too little detail concerning the frequency, intensity, time, and type of exercise to allow for determination for an exercise dose-response. Similarly, limited detail about the adherence to the exercise program was provided, and few studies had been designed to include monitoring of activity in the comparison group, so that potential contamination could be gauged.

• A total of 717 participants were included, with sample sizes for individual studies ranging from 16 to 123 participants.
• Participants in the included studies were women with early to later stage (stage 0–III) breast cancer or who had undergone breast cancer surgery with or without adjuvant cancer therapy.
• Clinical heterogeneity in treatment (e.g., chemotherapy, radiation therapy, and hormonal therapy) was evident, particularly in trials of exercise during adjuvant treatment for breast cancer.

Six studies involving 319 patients assessed the effect of exercise on symptoms of fatigue. Although all of the studies showed improvements in symptoms of fatigue with exercise, only two reported statistically significant improvements. These two studies were also the only studies performed following breast cancer treatment. The pooled results from all six studies showed that exercise significantly improved symptoms of fatigue (standardized mean difference [SMD] = 0.46; 95% confidence interval [CI] [0.23, 0.70]). The pooled results from the four studies performed during adjuvant cancer treatment showed a nonsignificant effect on fatigue (SMD = 0.28; 95% CI [-0.02, 0.57]). Four studies reported adverse events; in one study, two of 23 participants reported that participation in the home-based exercise program (self-monitored walking program) resulted in worsening of fatigue.

• Of the 14 studies included in this review, the median score for methodologic quality was 3 (range 0–8). Only four of the 14 studies were considered high quality.
• The most common methodologic shortcomings included failure or inadequate blinding of outcome assessor and inadequate participant concealment of study group allocation.

PURPOSE: To review an article from a non-peer–reviewed journal on managing bleeding malignant skin lesions

• Twenty-one references specific to prevention of bleeding in malignant skin lesions
• Nonpharmacologic measures within non-peer–reviewed nursing journals

• Amorphous and alginate dressings discussed in wound management to keep wound moist
• Multiple-layer dressings recommended to prevent bleeding and prevent adherence and subsequent trauma to the wound and absorption
• Alginate dressings recommended to control light bleeding
• Topical epinephrine recommended to control profuse bleeding

The journal is not peer-reviewed.

To determine if providing, to hospice patients and caregivers, systematic feedback from standardized assessment tools improves the quality of hospice care

Hospice teams were formed, each with a similar composition. Patients were randomly assigned to receive standard care (control) or standard care plus systematic assessment. Patient-caregiver dyads were identified and screened, within 24–72 hours of admission, with the Short Portable Mental Status Questionnaire. Research assistants (RAs, an RN and a social worker) collected baseline data from both the patient and caregiver, respectively, and then collected data one and two weeks later, using identified tools. Verbal and written reports were given at two interdisciplinary team conferences after each data collection. RAs performed a chart audit for both groups during the study. The control group completed the same standardized assessments, but no reports were made to the interdisciplinary team.

• The original sample was composed of 709 participants: 350 dyads completed all three measurements, and 366 left the study at some point over the course of follow-up.
• Mean patient age was 74.05 years; mean caregiver age was 71.83 years.
• Mean age of all caregivers was 65.37 years: in the control group, mean caregiver age was 65.49 years; in the experimental group, mean caregiver age was 65.24 years.
• Mean age of all patients was 72.66 years: in the control group, mean patient age was 72.67 years; in the experimental group, mean patient age was 72.65 years.
• The caregiver sample was 26.4% male and 73.6% female. The patient sample was 56.3% male and 43.7% female.
• Patients had a cancer diagnosis and were receiving hospice care.
• Caregivers had to be older than age 18, able to read and understand English, and able to pass the mental status screening.
• Mean years of education was 13.21 years for caregivers and 12.14 years for patients. 
• Patients' mean Palliative Performance Scale score was 57.06; patients' mean Short Portable Mental Status Questionnaire score was 9.23.

• Multisite
• Home
• Two large, private not-for-profit hospices in Florida, United States

• Phase of care: end-of-life care
• Clinical applications: end-of-life and palliative care, late effects and survivorship

Randomized controlled trial 

• Palliative Performance Scale (PPS), to assess the physical condition and functional status of people receiving palliative care. The PPS includes three broad areas: mobility, intake, and level of consciousness in five categories. The scale, 0%–100%, is divided into 10% increments, with 0 meaning dead and 100 meaning normal. Validity and reliability were assessed.    
• Memorial Symptom Assessment Scale (MSAS), revised, to assess occurrence, intensity, and distress from symptoms. A total of 25 items are rated 0–4 for severity and distress, resulting in subscale scores for intensity and distress that range 0–100. Validity and reliability were assessed.
• Hospice Quality of Life Index–14 (HQLI-14). HQLI-14 is a shortened version of the validated HQLI. The HQLI-14 includes three aspects of overall quality of life (QOL): psycho-physiological well-being, functional well-being, and social-spiritual well-being. Fourteen items are scored 0–10, with 10 being the most favorable response. Item scores are added to obtain a total scale score ranging from 0 (worst QOL) to 140 (best QOL).
• Center for Epidemiologic Study Depression Scale (CESD), short form. The short form of the CESD is a 10-item true-false instrument validated for use in clinical settings. Items are either present or absent. Validity and reliability are strong.
• Spiritual Needs Inventory (SNI). The SNI assesses the extent to which individuals have spiritual needs and indicates which needs remain unmet. The SNI is a 17-item questionnaire with two main parts: The first rates items in response to a stem 1 (never) to 5 (always). Scores may range from 17 to 85, with a higher score representing a greater spiritual need. Individuals also choose yes or no to incide whether the need was met. Validity and reliability were assessed.
• Short Portable Mental Status Questionnaire (SPMSQ). The SPMSQ presents 10 items to measure cognitive impairment. Eight or more correct answers qualified patients and caregivers to remain in the study. Validity has been assessed.

The control and intervention groups were comparable in regard to every variable except patients' years of education. Attrition was greater than 51%. In dyads that completed the study, patients were older and had higher functional status scores at baseline. No other comparisons were statistically significant. Results showed improved patient depression (p < 0.001) as a result of the intervention and improvement in both groups in patients’ QOL (p < 0.001). No other patient outcomes (symptom distress, spiritual needs) or caregiver outcomes (depression, support and spiritual needs) were statistically significant.

The addition of the systematic assessment of depression to usual care probably had a greater effect because it is not a symptom on which hospice staff normally focus. Improving depression is an important way of improving overall QOL of patients and their families during hospice treatment. The lack of improvement in caregiver variables in either group over time may suggest the need for greater attention to this symptom.

• Dyads might not have used the information provided.
• The study had a high level of attrition (greater than 51%).
• Only patients who remained functional throughout the whole course of study were selected.
• The information-only intervention may have been insufficient to lead to staff change.
• The control group may not have been valid in the sense that high-quality usual care may have been similar to the intervention: The number of visits did not change significantly in the intervention group.
• A study may have included a confounding effect: Hospice workers may have provided care of such good quality that results were affected by more than the intervention itself.

Hospice is an effective service, and efforts to improve hospice care should be a priority. Caregivers as well as patients should be a focus of hospice care. The study supports the systematic assessment of depression in hospice patients. The study also supports the need for greater attention, via research and systematic assessment, to caregivers in the hospice setting.

To determine if exercise interventions can effectively mitigate cancer-related fatigue (CRF)

DATABASES USED: PubMed, CINAHL, PsycINFO, ProQuest, SPORTDiscus

KEYWORDS: exercise, physical activity, exercise therapy, exercise training, aerobic exercise, resistance exercise, physical training, exercise prescription, cancer, oncology, malignancy, neoplasm cancer treatment, chemotherapy, radiotherapy, hormonal therapy, fatigue, CRF, QOL, depression

INCLUSION CRITERIA:

• Experimental, quasi-experimental, or pre-post design
• Data reported and available for meta-analysis
• Inclusion of exercise intervention to measure effects on CRF
• Control groups received care as usual with no prescribed physical activity

EXCLUSION CRITERIA:

• Interventions and measures focusing only on range of motion

TOTAL REFERENCES RETRIEVED = 948 articles initially identified

EVALUATION METHOD: No quality scoring of retrieved studies was described.

FINAL NUMBER STUDIES INCLUDED = 16 studies included in meta-analysis

SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Study sample sizes ranged from 22–242; 1,426 patients in treatment and control groups

KEY SAMPLE CHARACTERISTICS: Subjects were at various phases in cancer treatment, with some in active treatment of various modes and others post-treatment. Eight trials were in patients with breast cancer. Other studies included prostate cancer, mixed disease types, and acute myelogenous leukemia.

Overall effect of exercise on CRF showed a small but significant effect size with overall reduction in CRF ( SMD = 0.28, 95% CI 0.17–0.38, p <.001).

Subgroup analysis of exercise mode:

• Aerobic exercise had a small but significant positive effect (SMD = 0.25, 95% CI 0.12–0.38, p < .001)
• Resistance training had a small and insignificant effect (SMD =1.66, 95% CI 0.41–3.73, p > .05)
• Mixed aerobic and resistance exercise had a small and insignificant positive effect (SMD = 0.22, p > .05)

Interventions provided in a supervised setting (15 trials) significantly reduced CRF (SMD = 0.29, 95% CI 0.17–0.46, p < .001).

Unsupervised exercise showed a positive trend but no significant difference with exercise.

Effects in phase of treatment:

• Exercise caused a moderate and significant reduction in CRF when provided after completion of treatment (SMD = .31, 95% CI 0.6–14.03, p < .001).
• Exercise during treatment also resulted in reduced CRF (SMD = 0.24, 95% CI .12–.36, p < .001).

Effects in patients with cancer other than breast cancer:

• Subgroup analysis in trials with those patients with cancer other than breast cancer (four trials) showed that exercise significantly reduced CRF (SMD = 0.17, 95% CI .01–0.34, p < .05).

Exercise intervention produced improvement in aerobic fitness and musculoskeletal fitness (p < .001).

Findings from meta-analysis provide strong support for the positive effect of exercise on CRF. Effect sizes are small.

Findings suggest that various modes of exercise show a trend toward a positive impact on CRF in patients with breast cancer, as well as patients with other types of cancer.

There may be differences in effect based on mode of exercise.

Findings suggest positive effects in supervised and unsupervised exercise programs, but only those that were supervised demonstrated statistical significance in this study. It is unclear if this represents a real difference in effectiveness, or the fact that there were only four studies of unsupervised exercise included.

Findings support the use of exercise to reduce CRF during and after completion of cancer treatment. Subgroup analyses in this study begin to provide additional useful information regarding the modes and types of exercise interventions that may be most effective. Further research comparing effectiveness of various approaches is warranted.

Effect sizes of exercise are small, suggesting that studies that include patients with very low fatigue or interventions to prevent fatigue may not readily show significant changes.

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 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.

• 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. 

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

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

A three-group randomized controlled trial design was used.

• 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 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.

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.

• 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 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. 

The COPE method involves the following four interventions.

• Creativity (viewing problems from different perspectives to develop new strategies for solving caregiving problems)
• Optimism (having a positive but realistic attitude toward the problem-solving process)
• Planning (setting reasonable caregiving goals and thinking out, in advance, the steps necessary to reach those goals)
• Expert information (what nonprofessionals need to know about the nature of a problem and when to get professional help and what family caregivers can do on their own to deal with the problem)

The COPE intervention was delivered by nurses, and a home health aide was present for each visit to provide respite so that caregivers could focus on the intervention. No specific data were given on length of intervention, although it was inferred to occur over two weeks. The study was divided into three arms.

• Group 1 was hospice standard care only (n = 109).
• Group 2 was hospice standard care plus supportive visits from the intervention nurse and home health aide made on the same schedule as the COPE intervention group (same amount of time per session as group 3, nurse provided individual support and discussed feelings) (n = 108).
• Group 3 was hospice standard care plus intervention visits by a nurse who taught them the problem-solving method (n = 111).
   

• The sample (N = 328) included adults with cancer in a hospice program and their caregivers (caregivers identified by hospice without having cancer themselves).
• Patients had at least a sixth-grade education and were cognitively intact.

• Home

A properly designed randomized, controlled trial with three arms was used.

• Caregiver demands scale (to measure burden)
• Caregiver Quality-of-Life Index–Cancer Memorial Symptom Assessment Scale (measures burden of cancer symptoms)
• Caregiver mastery
• Brief COPE scale (to measure use of problem-focused versus emotion-focused coping strategies)

Significant group by time interactions were found between the standard group and the COPE group (group 3) in quality of life, symptom burden, and caregiving task burden. No significant differences were found between the standard group and the support condition (group 2) in quality of life, symptom burden, or caregiving task burden. The COPE group had significant improvements in symptom burden over time, whereas the usual care group did not. Mastery and coping skills were not significantly different among groups.

Although substantial attrition occurred across all three groups longitudinally, researchers examined for differences. The only significance found was that completers were initially older than noncompleters. No effects of attrition by group were significant.

• No specific information was given regarding how many intervention sessions were delivered, what happened at each session, or what the total length of the intervention was (although it is inferred to be within two weeks).