To determine whether lidocaine-prilocaine cream decreases injection pain related to sentinel lymph node biopsy

Eligible subjects were randomized to either the treatment or control group, then provided with a syringe that contained either the study medication (lidocaine-prilocaine cream) or a placebo cream that looked identical to it. Subjects also received instructions on how to apply the cream and a copy of the postprocedure survey, which asked patients to evaluate ease of application as well as level of pain. The subjects were to apply the given cream and then a barrier dressing to the area. Patients went to one of three radiology departments to receive an injection of the Tc sulfur colloid for the sentinel lymph node biopsy. Postoperatively, over the telephone, the patients completed the survey with help from a researcher. 

• The sample was composed of 39 patients.
• All patients were older than 18 years.
• All the patients were female.
• All the patients had breast cancer
   

• Multisite
• Inpatient and outpatient settings
   

Phase of care: active treatment

Triple-blinded prospective randomized placebo-controlled trial

• Scale measuring ease of cream and dressing application, a five-point Likert-type scale    
• 10-point pain scale, to measure pain
• A tool that recorded whether patient would recommend cream (yes/no)
   

Thirty-nine subjects completed the study. Subjects from both groups rated the cream as easy to apply, and both groups responded similarly in regard to dressing retention. Authors reported no significant difference in median injectional pain scores between the treatment and control groups. Authors noted two trends: The treatment group was more likely than the control group to recommend the cream, and the control group was more likely to rate the injection as painful or extremely painful.

The pain scores of subjects who received the lidocaine-prilocaine cream were not significantly lower than those of the control group.

• The study had a small sample size, with fewer than 100 patients.
• The study comprised variability in injection techniques and volumes.
• Study design was based on the prediction of a large difference (4) between the two groups on a 10-point Likert scale.  
   

This study does not indicate that a topical anesthetic, lidocaine-prilocaine cream, had a significant effect on injectional pain; however, the finding may be a consequence of the study design. Further studies, with larger sample sizes and smaller predicted differences in the study groups, may produce a different result.

To evaluate the effects of a tailored information package for patients with rectal cancer on levels of satisfaction with information, anxiety, depression, and readjustment to normal living

This study was conducted at six sites in four healthcare systems in Northern Ireland. A process evaluation of usual standards-of-care established that all patients with rectal cancer were referred to a stoma nurse specialist following diagnosis. A tailored information packet of 14 leaflets dealing with various aspects of disease and treatment was developed based on the theoretical framework of andragogy, developed by Malcolm Knowles, along with a preliminary needs assessment and a literature review. Preparation for the study involved a liaison between stoma-care nurse specialists to determine interest in participation. The researchers then met with the stoma nurse specialists to discuss the study protocol and provide consistent training regarding the use of the information packet. Data were collected using a researcher-administered set of scales at three time points in structured interviews. These were preintervention, postintervention, after surgery, prior to hospital discharge, and six months after surgery.

• N = 43 (intervention group), 33 (control group)  
• AGE RANGE = 42–76+ years
• MALES: 64.5%, FEMALES: 35.5%
• KEY DISEASE CHARACTERISTICS: Sixty-eight out of 76 patients were considered a B or C in Duke’s staging system. The majority of patients (40) had low anterior resections with loop ileostomies, and 27 patients had abdominoperineal resections (permanent colostomies).
• OTHER KEY SAMPLE CHARACTERISTICS: Thirty-two patients received short-course radiation prior to surgery. Ten of these patients also had adjuvant chemotherapy. Nine patients had long-course preoperative chemotherapy/radiation, and nine patients had adjuvant chemotherapy only.

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Northern Ireland

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

Randomized, controlled trial

The Patient Satisfaction with Cancer Treatment Education (PSCaTE) questionnaire was used. It consists of 14 items. Each item has a scale from 1 (strongly disagree) to 5 (strongly agree). The Hospital Anxiety and Depression Scale (HADS), which contains seven intermingled items answered on a four-point scale, and the Reintegration to Normal Living Index (RNLI), which consists of 11 items on scales of 1–10, also were used. Data analysis was carried out using SPSS software.

There was a statistically significant difference in levels of satisfaction with information between the intervention and control groups. Patients who received the tailored information packet were more satisfied with their information than the control group. There were no differences in depression scores between the intervention and control groups at any time. Females were shown to have significantly higher anxiety and depression scores at the preintervention assessment. All participants with high depression scores also had elevated anxiety scores. Anxiety and depression scores showed medium to large negative associations with adjustment levels as measured by the RNLI scores at all three time points.

Patients who received the tailored information packets were significantly more satisfied than those in the control group at the second and third time points.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: This study only assessed satisfaction up to six months following surgery. Caregivers were not included in the study. This study focused predominantly on paper-based literature as an intervention. The Pearson coefficient was used in the analysis to assess for satisfaction; although this is appropriate, it is not as robust in terms of statistical significance.

To test the effectiveness of a six-week, web-based, multiple health behavior change program called Surviving and Thriving With Cancer (STC) for adult cancer survivors

STC was a six-week online patient education course with modules on nutrition, changes in body, sleep, and other side effects associated with cancer treatment recovery. Nine online cohorts consisted of 20–25 survivors. Sessions had 30–35 webpages of material geared toward skills building with specific content to build self-efficacy. Each week, users identified a health behavior to change and were guided to set realistic, achievable goals. Action plans were posted in a discussion center where two trained cancer survivor facilitators provided feedback and help. Participants were prompted at the middle and end of the week via an automated message to update progress and give feedback to other participants. The website contained components called \"Discussion Center,\" \"My Tools,\" \"Post Office,\" and \"Help.\" The discussion center facilitated social networking through four threaded bulletin boards: action planning, problem solving, difficult emotions, and celebrations. Randomization occurred by groups of 40–50 participants after the completion of baseline a questionnaire. Half were assigned to treatment and half to a wait-list control group. Data collection occurred at baseline and after six months during follow-up.

• N = 352  
• MEAN AGE = 49.3 years (control); 52.4 years (intervention)
• MALES: 16% (control); 20% (intervention), FEMALES: 84% (control); 80% (intervention)
• KEY DISEASE CHARACTERISTICS: Adult cancer survivors recruited online, though referrals, or by mailings; 18 years of age or older; after completion of primary cancer treatment at least four weeks prior but not more than five years before joining the study; diagnosis with only one cancer and no recurrence; access to the Internet; ability to read English
• OTHER KEY SAMPLE CHARACTERISTICS: 85%–89% Caucasian; 83%–84% breast cancer (early stage); majority were healthy; highly educated and well-adjusted

• SITE: Multi-site
• SETTING TYPE: Other
• LOCATION: Recruited from oncology clinics, a tumor registry, and online mechanisms such as Facebook and the Association of Cancer Online Resources

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled, delayed-treatment design

• Demographic and clinical information
• Brief Fatigue Inventory (BFI)
• Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
• Godin Exercise Questionnaire
• The Block Food Frequency Questionnaire (number of servings of fruits and vegetables per week)
• Patient Health Questionnaire (PHQ-8)

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey), and participants in the intervention arm reported significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to patients in the control arm. Compared to the control group, the intervention group experienced an improvement in insomnia from baseline to six months 9.6–9.2 versus 9.6–10.1 (p = 0.03). There were no significant changes in fruit and vegetable consumption or other outcomes.

The intervention affected insomnia and exercise; however, the majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Participants’ ability to make substantial health behavior changes may have been limited.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Roughly 14% of participants who were randomized did not provide any data at six months (but groups did not differ). Sixty percent of the interested participants were highly educated and were recruited from online social networking sites, suggesting that participants were active on the Internet. Therefore, the sample characteristics may bias the results. Overall, the participants were healthy and well-adjusted with little to no need for significant changes in their health behaviors. The majority of participants were Caucasian (87.2%) and female (82.1%), limiting generalizability. A significant difference in age was found among the treatment and wait-list groups. The mean number of sessions logged on at least once was 5.3 (SD = 1.28, range = 0–6), and 67% of participants attended all six sessions, which may have affected the outcomes. Health behaviors were self-reported, and there may have been over- and underestimation of exercise and fruit and vegetable intake because of social desirability or recall bias. The significance level was not adjusted for the multiple comparisons of numerous outcomes.

Web-based interventions are relevant for people who are not near facilities that could offer face-to-face interventions. Health behavior change interventions are relevant for cancer survivors, so continuing to test and refine interventions is imperative in the area of cancer survivorship.

To determine the effect and preferred dose of polyethylene glycol 3350 (PEG3350) in children with functional constipation.

Patients were randomly assigned to placebo or PEG at different doses that were identical in appearance. Dosage groups were 0.2, 0.4, or 0.8 g/kg per day. Patients took the medication for two weeks. Patients in both PEG and placebo groups also underwent behavior modification. Patients returned for evaluation after seven and 14 days of medication.

• The study reported on a sample of 103 healthy patients with functional constipation.
• Mean patient age was 8.5 years (SD = 3.1).
• The sample was 34% female.

• Multi-site
• Outpatient
• United States

The study has clinical applicability for pediatrics.

This was a double-blind, placebo-controlled, prospective, randomized study.

• Diary (parents)
• Physical examination
• Laboratory (chemistry, serum osmolarity, and liver function tests)
• Printed calendars (pediatrics with stickers)

• More patients taking PEG had bowel movements compared with the placebo group (p = 0.026), but no difference existed among the PEG dose groups in terms of one dose being better than another.
• Patients in the PEG groups had more stools than those in the placebo group (p = 0.017).
• Response rates were not significantly different between children aged younger than 8 or older than 8.
• Patients in the PEG groups had other benefits such as improved stool consistency and less straining.
• The treatment was well tolerated.

PEG is a well-tolerated, effective treatment for chronic constipation in healthy children.

• The study only lasted for two weeks.
• A behavioral modification given as part of the collection process in which children received positive and negative reinforcement could have influenced the results.
• The sample was healthy children; application in children with cancer is not clear.

This well-done study demonstrated the usefulness of PEG in the management of constipation for healthy children. PEG may be useful for children with cancer, but this specific application has not been studied.

To evaluate the efficacy of a smoking cessation medication in controlling symptoms of hot flashes in patients with breast cancer receiving hormonotherapy

In the first phase of this crossover clinical trial, the intervention group received bupropion 150 mg for three days and 300 mg during the rest of the four-week period. The control group received placebo in the same four weeks. After one week of washout time, the groups were combined and crossed over to receive the same dose as the intervention or placebo at the beginning for four more weeks. The study was 10 weeks in length for both groups.

• N = 55  
• MEAN AGE: 49 years (33–71 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with breast cancer undergoing hormonal therapy, with seven or more hot flashes per week
• OTHER KEY SAMPLE CHARACTERISTICS: Not tumor disease, already completed active treatment at least three months prior

• SITE: Single site  
• SETTING TYPE: Not specified   
• LOCATION: Foundation School of Medicine, Sao Paulo, Brazil

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care, palliative care

• Double-blinded clinical trial
  • Randomized, placebo-controlled, crossover, pilot

• A daily diary on the number and severity of hot flashes
• ASEX scale to assess sexual function
• Beck Depression Inventory (BDI)
• Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Blood pressure and heart rate to evaluate physical signs

The reduction in hot flashes for the intervention group was 1.26 per day, without any difference in sexual function occurring nor statistical significance of side effects experienced between groups.

There was no activity shown for bupropion over placebo for control of hot flashes.

• Small sample (< 100)

Bupropion is not recommended in practice for women with breast cancer. It was not statistically significant in controlling the symptoms of hot flashes in comparison with the placebo group.

To evaluate the psychological, endocrine, and immunologic effects of a relaxation and visualization therapy (RVT) in breast cancer patients undergoing radiotherapy

Investigators randomly assigned participants to one of two groups: the relaxation visualization (RVT) group or the control group. The RVT intervention consisted of 30-minute structured group sessions led daily by a trained investigator. Each RVT session took place immediately following radiation. Subjects were also instructed to perform the RVT exercise at home twice a day, with the aid of a telephone-call reminder and a tape. The RVT intervention occurred daily for 24 days. The control group received radiation only. Investigators obtained psychological assessments as well as blood and saliva samples at baseline and after the 24-day intervention.

• The sample was composed of 34 participants; 20 in the experiment (RVT) group and 14 in the control group.
• Mean patient age in the control group was 50.07 years (SD = 2.68 years); the age range in the control group was 36–70 years.
• Mean patient age in the RVT group was 54.20 years (SD = 1.24 years); the age range in the RVT group was 45–65 years.
• Investigators discovered no significant differences between groups in regard to any of the demographic variables, including age.
• All the participants were female; all had stage I or II breast cancer, and all were receiving radiotherapy.

• Single site
• Outpatient
• Brazil

Active treatment

Prospective randomized trial design with randomization and repeated measures

• Lipp Inventory of Stress Symptoms for Adults (ISSL)
• State-Trait Anxiety Inventory (STAI)
• Beck Anxiety Inventory (BAI)
• Beck Depression Inventory (BDI)
• Structured clinical interview to assess psychosocial variables
• Neuroimmunologic parameters: salivary cortisol and peripheral blood cells

At baseline the experimental group was significantly more anxious than the control group, according to the BAI and STAI. Within-group analysis for the control group revealed no significant changes in any of the psychological scores over time. However, the experimental group demonstrated significant declines in levels of stress, anxiety, and depression over time (p < 0.05 for all measures). Interestingly, the mean scores relating to the psychological measures of the experimental group, at the post-time point (after completion of the study), were all higher than the mean post- scores of the control group. Cortisol levels and lymphocyte proliferation did not change over time for either group.

The RVT intervention was effective in reducing psychological distress but did not seem to affect the endocrine (cortisol) or immune measures (lymphocyte proliferation).

• The study had a small sample size, with fewer than 100 participants.
• The study had risks of bias due to no appropriate attentional control condition and because participants' levels of anxiety differed.
• All participants had gone without chemotherapy for two weeks, but this may not have been sufficient for complete immune recovery; the study presents no way to ascertain this because it lacks a \"true\" baseline value.

Use of adjunct therapies, such as relaxation and visualization, may help ease the psychological distress associated with cancer and its treatment.

To evaluate the use of morphine as a first-line medication for pain in patients with advanced or metastatic cancer instead of the World Health Organization (WHO) ladder

• N = 60  
• AVERAGE AGE = G1 58.7 years (SD = 12.4 years); G2 57.5 years (SD = 12.7 years)    
• MALES: G1 83.33%; G2 90%, FEMALES: G1 16.67%; G2 10%
• KEY DISEASE CHARACTERISTICS: No specific disease was targeted although there was a high incidence of head and neck cancer. 

• SITE: Single site    
• SETTING TYPE: Inpatient

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

Retrospective, randomized study

• A confidence level of 95% and a study power of 80% were used. This determined that 30 patients per group were needed.
• In total, 150 patients were screened, and 60 met inclusion criteria.

Twenty-four patients in G1 and 29 in G2 completed the study. There was no difference in patient satisfaction between the groups. There was a higher incidence of adverse effects (i.e., vomiting, nausea, constipation) in G2. This supported what is seen in the literature. These effects were manageable and did not negatively affect quality of life. The study was conducted over three months although the sample was obtained over two years and six months. There were no consistent differences in pain severity between the groups.

This study demonstrated the efficacy of both methods for the reduction of pain intensity in both groups, and that both methods are comparable.

• Small sample (< 100)
• Other limitations/explanation: Double-blinding was not possible.

Morphine as a first-line treatment for patients with advanced and moderate cancer appeared to be acceptable as a treatment for pain. The management of adverse symptoms was manageable and was comparable to traditional therapy. 

The relaxation intervention was a 30-minute, therapist-led group with relaxation and visualization therapy (RVT) consisting of relaxation, guided imagery, progressive muscle relaxation, meditation, and deep breathing. Each group had up to four patients. The intervention was delivered daily for 24 treatments immediately following radiation treatments. Patients self-administered the treatment at home using audiotapes twice per day. Patients received telephone calls to remind them to perform the intervention at home. Measures of psychological, endocrine, and immunologic data were collected at baseline and after the 24-day intervention.

The study reported on a sample of 34 women with breast cancer receiving radiation treatments (intervention group = 20; control group = 14).

A randomized controlled trial design was used.

• Inventory of Stress Symptoms–Lipp for adults (ISSL)
• State-Trait Anxiety Inventory (STAI)
• Beck Anxiety Inventory (BAI)
• Beck Depression Inventory (BDI)

Analyses were controlled for basal anxiety levels (trait anxiety). The psychological scores did not change over time in the control group, but the experimental group showed significantly reduced levels of stress, anxiety, and depression scores following the 24-day RVT treatment (all p < 0.05). Experimental and control groups showed similar stress and depression scores at baseline. Patients in the experimental group were more anxious than patients in the control group at baseline.

While no biologic changes were noted with RVT, there were significant improvements in psychological functioning with RVT.

The study had small sample sizes.

To evaluate the effectiveness of sucralfate mouthwash in preventing 5-fluorouacil (5-FU) -induced oral mucositis (OM)

Patients were block randomized to receive sucralfate or an identical-appearing placebo. They were instructed to swish 10 ml of mouthwash for 2 minutes and then swallow it. The mouthwash was to be used four times per day starting on day 1 of radiation therapy (RT) and continuing until day 15.

Patients received throat swabs at the beginning of treatment to exclude infection. All patients used cryotherapy and the same salvage treatment (xylocaine topical, acetaminophen/codeine, then morphine sulfate if needed).

Patients were given 1 liter of study drug, and compliance was assessed by the volume left over after day 15. Research nurses contacted each patient by telephone after one week to assess compliance with the mouthwash and complete questionnaires.

• The study reported on 81 patients with colorectal cancer receiving 5-FU and leucovorin for one cycle; 42 patients were in the sucralfate group and 40 were in the placebo group.)
• The median age of patients was 61 years.

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

Patients graded the severity of mucositis at the same time each day (in the evening) for 15 days using a 0–4 rating scale developed by the North Central Cancer Treatment Group. In addition, 1–6 analgesic diaries, the McGill Pain Questionnaire, and a 0–10 quality of life measurement tool were used on follow-up visits.

No significant differences were found between the two groups in terms of the following measures.

• Sum of daily mucositis score (p = 0.86)
• Daily pain score (p = 0.90)
• Eating difficulty (p = 1.00)
• QOL (p = 0.57)
• Duration of mucositis (p = 0.74)
• Number of analgesics (p = 0.19)

More women experienced mucositis than men.

The patient and medical assessments differed, and the authors stated that patient reporting is believed to be more sensitive.

The study did not conclude that sucralfate was an effective solution for the prevention of oral mucositis in this study population.

• The trial was closed early because the placebo expired.
• The trial did not meet patient accrual numbers.
• Medical staff underestimated mucositis incidence.
• The study lacked statistical power.
• No daily assessment was done.
• The placebo mouthwash was not described.

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

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

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

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

Intervention Types

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

Appraisal Domain Results

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

Coping Resources Domain

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

Quality of Life Domain

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

Effect of Intervention Characteristics

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

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

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