STUDY PURPOSE: To assess effects of yoga on health-related quality of life, mental health, and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment.

TYPE OF STUDY: Systematic review

DATABASES USED: Cochrane Breast Cancer Specialised Register, MEDLINE (via PubMed), Embase, the Cochrane Central Register of Controlled Trials (2016, Issue 1), Indexing of Indian Medical Journals, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov 

YEARS INCLUDED: (Overall for all databases) did not give date range

INCLUSION CRITERIA: RCTs were eligible if they compared yoga interventions versus no therapy or versus any other active therapy in women with a diagnosis of non-metastatic or metastatic breast cancer, and if they assessed at least one of the primary outcomes on a patient-reported instrument, including depression, anxiety, fatigue, or sleep-disturbances.  

EXCLUSION CRITERIA: Duplicates, not including randomized control methodology, no assessment of relevant outcomes.

TOTAL REFERENCES RETRIEVED: 432

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Blinded/duplicated two-stage screening approach to select appropriate articles; critical review and article scoring was independently done by two researchers

FINAL NUMBER STUDIES INCLUDED: 23

TOTAL PATIENTS INCLUDED IN REVIEW: 2,166

SAMPLE RANGE ACROSS STUDIES: Only RCTs included.  

KEY SAMPLE CHARACTERISTICS: Sample sizes ranged from 18 to 309, with median of 74.5. Women's mean age ranged from 44 to 62.9 years, with a median of 54 years. All studies included women with non-metastatic breast cancer; one study included women with metastatic disease. Women included were at different stages in both their diagnosis and treatment. Cancer treatment type was varied.

PHASE OF CARE: Not specified or not applicable; details about each study’s participants not specified

APPLICATIONS: Elder care, palliative care

As relevant to these PEP topics, yoga primarily improved health-related quality of life, fatigue, and sleep disturbances. Evidence suggests short-term effects of yoga compared with psychosocial/education interventions on depression, anxiety, and fatigue. During active cancer treatment, yoga improved depression, anxiety, and fatigue compared with no therapy or psychosocial/educational interventions. After therapy, yoga showed effects on health-related quality of life, fatigue, and sleep disturbances. The studies were not robust enough to measure effects of yoga more than five years after diagnosis or in the metastatic breast cancer population.

Evidence supports that yoga can have benefits on health-related quality of life in patients with breast cancer, including a decrease in anxiety, depression, and fatigue. Additional research is needed to assess the effectiveness of yoga more than five years from diagnosis and in the metastatic population.

Yoga has been shown to be an evidence-based intervention which can improve health-related quality of life and symptoms, including depression, anxiety, and fatigue, in women with non-metastatic breast cancer at all stages of treatment, up to five years postdiagnosis.

To evaluate differences in psychological states between breast cancer survivors who do practice yoga and those who do not

This case-control exploratory study consisted of two groups. The first was breast cancer survivors doing regular yoga (more than six months of regular yoga practice in the last year), and the second was women who had no prior yoga experience (or less than three yoga sessions in the last year). Yoga experience was self-reported by the participants, including their regular yoga schedule. No changes to their yoga practice or schedule were made by the researchers.

• N = 52   
• AGE: 30-65
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Female breast cancer survivors diagnosed with stage II or III ILC or IDC who received adjuvant chemotherapy and completed all treatment at least six months prior. 
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with neutropenia, grade 3 or 4 thrombocytopenia, and other reported chronic illnesses (diabetes, arthritis, hypertension, thyroid abnormalities, obesity, or recent acute infections) were excluded. Patients who participated in other complementary or alternative treatments within the past six months were also excluded.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Participants were screened at six-month follow-up appointment at three cancer centers in Bengaluru, India.

PHASE OF CARE: Late effects and survivorship

Case-control exploratory study

Perceived stress scale, Spielberg’s state and trait anxiety questionnaire, Beck’s depression inventory, General Health Questionnaire, WHO QOL Questionnaire-BREF

Analysis revealed significantly decreased anxiety, depression, and stress in the group that participated in yoga (p < 0.001). This group also reported better general health and overall quality of life (p < 0.001). Higher income predicted lower anxiety and depression scores, while better reported sleep quality predicted lower stress and depression scores as well.

This study supports yoga as an intervention to decrease anxiety, depression, and stress in breast cancer survivors.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: Differences in regular yoga practices among the participants could have influenced the results as yoga schedules were not controlled for. In addition, this study only looks at yoga in breast cancer survivors and may not be generalizable to other patients with cancer.

Yoga is an evidence-based intervention that may reduce anxiety and depression in patients with cancer. Although this study only examined breast cancer survivors, discussing yoga as a method to decrease anxiety and depression may be an appropriate option for many patients with cancer.

STUDY PURPOSE: To identify core components of self-management education interventions and assess effectiveness

TYPE OF STUDY: Systematic review

DATABASES USED: Ovid, MEDLINE, EMBASE, Cochrane collaboration, CINAHL, PsycINFO

INCLUSION CRITERIA: Adults, use of any type of teaching strategy, addressed any single core element of self-management interventions as defined by the authors, group based or individual structure

EXCLUSION CRITERIA: Psychotherapy or support groups, use of only information such as leaflets or videos, focus on family members, focus on decision making by patients, gray literature, interventions related to diet and exercise

TOTAL REFERENCES RETRIEVED: 4,579

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias tool to evaluate study quality. All were at high risk of bias related to lack of blinding

FINAL NUMBER STUDIES INCLUDED: 43 

TOTAL PATIENTS INCLUDED IN REVIEW: 6,795

SAMPLE RANGE ACROSS STUDIES: 22 to 483

PHASE OF CARE: Multiple phases of care

Authors attempted to correlate core elements of interventions with outcomes. Overall, there were very few studies that had any common combinations of core elements, so this analysis could not be done. Overall, studies suggested that psychoeducational interventions may be beneficial for relieving symptoms of anxiety and depression. The content, elements, structure duration and frequency of interventions across studies were varied. Many interventions labeled as self-management education did not include components related to self management.

Psychoeducational interventions appear to be beneficial for symptoms of anxiety and depression. It is not possible to determine the specific components of these types of interventions that are most helpful.

• Mostly low quality/high risk of bias studies
• High heterogeneity
• Wide variation of the components, etc., of these types of interventions

Psychoeducational interventions of various types can be beneficial in reducing patients’ anxiety and depressive symptoms.

To evaluate the effectiveness of a psychoeducational program on cancer-related fatigue

Patients were randomly assigned to the study intervention or usual care. Patients in the intervention group (PEPs) received written information explaining cancer-related fatigue and difference approaches for management. Patients in this group were also encouraged to participate in five group educational sessions of two hours each over a six-week period. The PEPs content was designed to incorporate NCI and CPEN guidelines. Content included information about the disease, fatigue, self expression of attitude, coping strategies, and skill development for managing fatigue. Educational teams received a two-day intensive training to standardize program content. Patients in the control group received the written documentation as described. After the study, patients in the control group were offered participation in the program.

• N = 129   
• AGE: Mean = 55.9 years
• MALES: 15.6%  
• FEMALES: 84.4%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Multiple tumor types–over 60% were breast cancer cases. Average of slightly less than one month since diagnosis.
• OTHER KEY SAMPLE CHARACTERISTICS: Mean baseline fatigue was 5 in both groups.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: France

RCT

• Numeric rating scale for fatigue intensity
• FACT-Fatigue
• Piper Fatigue Scale
• EORTC-QLQ-C30
• Hospital Anxiety and Depression Scale

There were no differences between groups in fatigue scores after the intervention, and no differences in the trajectory of fatigue. Fatigue declined overall in all patients. There were no differences between groups in anxiety or depression.

The educational program tested here did not demonstrate an effect on fatigue, anxiety, or depression.

• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Authors questioned the possibility of study group contamination since all patients were treated at the same clinical centers. No observations to check program fidelity were described. Phase of care is not clear in this report. Question of author bias–authors attribute lack of apparent effect to the need for better fatigue measures.

Psychoeducation is an intervention that has shown mixed results for impact on cancer-related fatigue and other symptoms. The specific program tested here did not demonstrate an effect. Fatigue in particular is a complex multifaceted symptom. Various psychoeducational and supportive approaches have also been complex in terms of design, content, timing, dose, etc. The effectiveness of psychoeducational-type interventions may relate to all of these aspects of both content and delivery.

To assess the impact of palliative care interventions on symptoms and quality of life among patients undergoing HCT

Within 72 hours of transplant admission, patients were randomized to treatment and control groups. Within 72 hours of group assignment, patients in the palliative care group met with the palliative care physician or advanced practice nurse for planning management of symptoms. Palliative interventions were provided according to guidelines in a manual developed for addressing pharmacologic and non-pharmacologic symptom management interventions. Study measures were obtained at baseline and during the second week of hospitalization, day 5 after autologous cell infusion, day 8 after allogeneic HCT, and at 3 and 6 months after HCT.

• N = 157    
• AGE: Mean = 57.05 years
• MALES: 42%  
• FEMALES: 58%
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Most had autologous HCT
• OTHER KEY SAMPLE CHARACTERISTICS: Most had college or more formal education. More than 70% were married.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Massachusetts

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care

RCT

• FACT-BMT
• FACT Fatigue score
• PHQ9 for depression
• Hospital Anxiety and Depression Scale
• Edmonton Symptom Assessment Scale (ESAS)

Hospitalization lasted an average of 21 days, ranging from 12-102.  Most commonly addressed symptoms were nausea, pain, diarrhea, and constipation. At two weeks, BMT scores (p = 0.02), fatigue scores (p = 0.04) ESAS symptoms burden scores (p = 0.02), and HADs anxiety and depression subscales (p < 0.008) were all better in the palliative care group. At three months, depression scores were lower in the palliative care group (p = 0.002). HADs scores, however, did not show clinically relevant levels of anxiety or depression. At three months, there was no difference between groups in fatigue, anxiety, or overall symptom burden. During hospitalization, caregivers of intervention patients reported less increase in depression (p = 0.03). Caregivers of those in the intervention group reported improvement in coping compared to those in the control group (p = 0.02).

Palliative care during hospitalization for HCT was associated with lower fatigue and symptoms of anxiety and 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
• Other limitations/explanation: Interventions for symptom control were not described. Anxiety and depression scores were not at a clinically relevant level for HADS, so it is unclear that differences seen were meaningful.

Palliative care service can be beneficial to patients for management of symptoms during hospitalization for HCT.

To evaluate feasibility and effectiveness of a brief psychosocial intervention delivered by front-line health professionals as part of a planned stepped integrated care model

Clinical sites were randomized to the intervention or control condition. Those randomized to the intervention received a training manual and had a one-day skill development program focusing on supportive-expressive, CNT, and dignity-conserving strategies. At intervention sites, the level of intervention was determined based on distress thermometer (DT) scores and assigned to trained healthcare providers. Patients with HADS scores of 8-21 received the health provider intervention described, and those with HADS scores of 22 or higher were referred for specialist treatment. Patients were contacted and offered up to four individual sessions by telephone or face to face. Weekly supervision was provided by a psychiatrist in a group setting. Patients completed baseline measurements in clinic visits and follow-up measures were provided via reply paid envelope. A phone reminder was done to encourage completion of follow-up measures. Health professionals who delivered the intervention included oncology nurses, physiotherapists, cancer care coordinators, radiation therapists, and an occupational therapist.

• N = 358   
• AGE: Mean = 58.9 years
• MALES: 29.9%  
• FEMALES: 69.1%
• KEY DISEASE CHARACTERISTICS: Varied tumor types–breast and gynecologic were most prevalent. Seventy-six percent had disease progression.  
• OTHER KEY SAMPLE CHARACTERISTICS: Most were married and not working. Formal education level ranged from less than high school to university education. Patients taking antidepressants were excluded.

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

Cluster, randomized, crossover, multi-site design

• Hospital Anxiety and Depression Scale (HADS)
• FACT-General for quality of life
• EQ 5D-5L
• Demoralization scale
• Unmet needs

There were no significant differences in outcome measures between those patients in the intervention or control conditions. In the intervention condition, 112 were allocated to written resources, 115 to the brief intervention, and 18 were allocated to specialist treatment. There were no differences in outcomes in any of these groups. Providers involved in delivering the intervention reported that it was difficult to provide this along with the other demands in daily practice.

The brief intervention delivered by various front-line healthcare professionals was insufficient to effectively manage depression or anxiety. The amount of skill development provided to the mix of providers involved may have been insufficient.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: The timing of follow-up measurement is unclear. The differences in effectiveness according to the provider used for the intervention may be a question. Some of these disciplines have no basic education in psychosocial intervention as part of professional education. Significant education and training for skill development and ongoing clinical supervision are required.

This study did not demonstrate effectiveness of this stepped program and brief intervention by varied healthcare professionals. Other research has shown that nurse-delivered programs can be effective. Many other disciplines do not have the depth of initial education in psychosocial care and may require much more education and training to develop sufficient skill to provide an effective intervention for anxiety and depression.

To study the effect of music on anxiety and depression

Patients listened to music for at least 20 minutes daily for three consecutive days. Music was provided through headphones and consisted of light music selected by experts. Study measurements were done daily after the intervention.

• N = 60   
• AGE: Range = 18-65
• MALES: 57.2%  
• FEMALES: 42.8%
• KEY DISEASE CHARACTERISTICS: 54% had soft tissue tumors; others were bone cancer and leukemia. The majority in both groups had stage IV disease.
• OTHER KEY SAMPLE CHARACTERISTICS: 63% had less than high school education. Baseline HADS score was slightly over 14 in both groups.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: India

Two-group, non-random, quasi-experimental

Hospital Anxiety and Depression Scale (HADS)

There was no significant change in HADS scores in the control group. HADS scores declined significantly over the three days of the music group (p < 0.001)

Listening to music was associated with short-term reduction in symptoms of anxiety and depression.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results

Listening to music is a low-risk intervention that may be of benefit in managing symptoms of anxiety and depression.

To evaluate acceptability and effects of MBSR on perceived stress and anxiety

Women with breast cancer were randomly assigned to MBSR or usual care groups. The usual care group could receive the MBSR intervention after the study was completed. MBSR was provided in two-hour weekly sessions for eight weeks. Study measures were obtained at baseline, after eight weeks, and three months later. The sessions were provided in groups of 4 to 6 patients. The MBSR intervention did not include a retreat.

• N = 58   
• AGE: Mean = 46.1 years (range = 30-62)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer, most were stage II
• OTHER KEY SAMPLE CHARACTERISTICS: Most had high school education and were of middle income range

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: China

PHASE OF CARE: Transition phase after active treatment

Single blind RCT

• Posttraumatic Growth Inventory
• State-Trait Anxiety Inventory
• Perceived Stress Scale

Those in the MBSR group showed lower perceived stress scores at eight weeks and three months (p = 0.00); scores also declined in everyone over time (p = 0.00). STAI cores declined more in the MBSR group (p = 0.00), with an effect size of 0.21. State anxiety also declined in everyone over time, with an effect size of 0.39 (p = 0.00).

MBSR had a positive effect to reduce anxiety in this study.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: Usual care was not described. No other interventions, such as medications for anxiety were discussed. Adherence to sessions was not reported.

This study showed that a mindfulness-based stress reduction intervention was associated with reducing anxiety levels in women with breast cancer. This is a low-risk intervention that can be helpful for individuals with cancer who have anxiety.

STUDY PURPOSE: Evaluate benefits of MBSR on psychological distress

TYPE OF STUDY: Meta analysis and systematic review

DATABASES USED: PubMed, EMBASE, and Cochrane Central Register from inception to June 2014

INCLUSION CRITERIA: RCT; comparison of MBSR to usual care; breast cancer; measures psychological outcomes such as anxiety, depression, or stress

EXCLUSION CRITERIA: Other types of cancer; did not use MBSR; unpublished

TOTAL REFERENCES RETRIEVED: 323

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Risk of bias assessment according to the Cochrane handbook. Five studies included were not RCTs, despite this as an inclusion criteria. Only one study showed appropriate randomization and was blinded. Non-RCTs were all high risk of bias.

FINAL NUMBER STUDIES INCLUDED: 8

TOTAL PATIENTS INCLUDED IN REVIEW: 964

SAMPLE RANGE ACROSS STUDIES: 13-336

KEY SAMPLE CHARACTERISTICS: All were women with breast cancer

PHASE OF CARE: Not specified or not applicable

Six studies (536 patients) recorded a significant effect on depression (MD = 5.09, p < 0.00001). Four of these studies were pre-/post-test design studies.  Four studies showed a significant effect on anxiety with MBSR (MD 2.79, p < 0.0001). Four studies investigated long-range results from 1 to 24 months. Two showed sustained effects of MBSR at 12 and 24 months.

MBSR is effective for reducing anxiety and depression among women with breast cancer.

• Limited search
• Limited number of studies included
• Mostly low quality/high risk of bias studies
• Low sample sizes
• It is not clear if all studies used traditional MBSR or the more recently seen shortened version of the intervention. Despite an inclusion criteria of RCT, the majority of studies included were not RCTs.

MBSR can be helpful for patients to reduce anxiety and depression. There is some debate about the best form of delivery and full content of MBSR interventions. Additional research is needed to determine if delivery of the intervention for self care via CD or DVD or via Internet applications is effective. Additional research is also needed to determine if shortened interventions that do not include a retreat are as effective, since the time commitment and cost of a retreat may be prohibitive in some cases.

STUDY PURPOSE: To synthesize the evidence regarding immediate and sustained effects of hypnosis on anxiety in patients with cancer

TYPE OF STUDY: Meta analysis and systematic review

DATABASES USED: Scopus, Medline, PsycINFO, Academic Search Premier, CINAHL, and SDOL

INCLUSION CRITERIA: Hypnosis used as intervention, children or adults with cancer, sufficient data for meta analysis, anxiety was an outcome variable

EXCLUSION CRITERIA: Hypnosis combined with another psychological intervention, comparison of different types of hypnosis

TOTAL REFERENCES RETRIEVED: 1,483

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Assessment of quality based on the Cochrane guidelines for RCTs. 13 studies were RCTs and 7 were quasi-experimental design

FINAL NUMBER STUDIES INCLUDED: 20 

TOTAL PATIENTS INCLUDED IN REVIEW: 878

SAMPLE RANGE ACROSS STUDIES: 25-87

KEY SAMPLE CHARACTERISTICS: The majority of studies were in breast cancer survivors; 6 studies were in children

Across all 20 studies, the immediate effect size was significant in favor of hypnosis (Hedges g = 1.05, p < 0.01). There was also significant heterogeneity. The sustained effect size was also significant in favor of hypnosis (Hedges g = 1.69, p < 0.01) across five studies. Heterogeneity for sustained effects was also significant. Hypnosis was more effective when it combined therapist delivery with self-hypnosis than self-hypnosis only. Higher effect sizes were seen in studies of children, with procedure-related anxiety and studies with RCT design. Analysis suggested publication bias, and showed that smaller studies tended to report more positive results. With adjustment for bias, the effect size was reduced from 1.05 to 0.46.

Hypnosis can be beneficial to manage anxiety among patients with cancer. Therapist delivered alone or in combination with self-hypnosis was more effective than self-hypnosis alone.

• Limited number of studies included
• High heterogeneity
• Low sample sizes
• Varied timing, method of delivery and measurement of outcomes. Sample was too small to do relevant subgroup analyses

Hypnosis may be a helpful intervention to manage anxiety in adults and children with cancer for short- and long-term effects. Therapist involvement was more effective than self-hypnosis alone. For patients with significant anxiety, this may be an intervention to be considered.