Mindfulness-Based Stress Reduction

To provide a quantitative, meta-analytic review of the efficacy of mindfulness-based therapy (MBT) for improving anxiety and mood symptoms in clinical populations

• Databases: PubMed, PsycINFO, the Cochrane Library.
• Keywords: mindfulness plus meditation, program, therapy or intervention, anxiety, mood, depression or stress.
• Inclusion criteria: Studies that included a mindfulness-based intervention, a clinical sample, and adults 18–65 years. The mindfulness program was not coupled with treatment using acceptance and commitment therapy or dialectical behavior therapy. Researchers included a measure of anxiety and/or mood symptoms pre- and postintervention, and they provide sufficient data to perform effect-size analyses.
• Exclusion criteria: Studies in which the interventions differed substantially from mindfulness-based stress reduction (MBSR) or mindfulness-based cognitive therapy (MBCT) in length; studies in which the MBT was not delivered in person.

• Method of included-study evaluation: Two authors extracted data and analyzed changes pre- to posttreatment, pretreatment to follow-up, and intent to treat. Evaluation included a modified Jadad assessment of methodological quality. Two independent raters performed the assessment. Inter-rater reliability was r = 0.96.
• The total number of studies reviewed initially was 727.
• The study detailed publication bias and effect size.

• The report evaluated 39 studies. Sixteen of the studies included a control or comparison group.
• Total sample size: 1,140; individual study samples: 8–103. The most common clinical disorder was cancer (n = 9), followed by generalized anxiety disorder (n = 5), depression (n = 4), and 16 other clinical disorders. Many studies targeted more than one disorder.
• The report did not cite sample characteristics.

MBT was moderately effective for improving anxiety (Hedges’s g = 0.63) and mood symptoms (Hedges’s g = 0.59) from pre- to post-treatment in the overall sample. Eight studies met criteria for elevated levels of depression symptoms at pretreatment; none of these involved patients with cancer.

The effects of MBT on depression and anxiety related to chronic conditions, such as cancer, might be smaller than expected, because patients may experience physical symptoms listed on depression or anxiety scales as a result of their physical condition or as a side effect of medical treatment.

• The study does not present information about type, stage, and treatment of cancer. The study does not describe sample characteristics other than adult age.
• Researchers do not describe the specifics of the mindfulness interventions. 
• Researchers used many tools to measure anxiety and depression. Understanding if these tools measured the same things is difficult.
• Clinical populations varied. Many populations had only one study to represent them. Therefore, generalizability is limited.

MBT is a promising intervention in the treatment of anxiety and mood problems in patients with medical diagnoses, including cancer.

To evaluate current evidence regarding the effect of mindfulness-based therapy (MBT) on symptoms of anxiety and depression in patients with cancer

• Databases used in the search were EMBASE, PubMed, PsycINFO, Web of Science, Scopus, and Cochrane Collaboration.
• Search keywords were mindfulness, MBT, MBSR, and cancer.
• Inclusion criteria were English-language studies reporting on adult patients with a current or former diagnosis of cancer who were receiving MBT or mindfulness-based stress reduction (MBSR) as an intervention. Studies included pre- and postintervention valid continuous measures of anxiety or depression symptoms.
• Exclusion criteria were unspecified.

• The study included 670 references.
• Authors used the Jadad scale to evaluate and comment on the literature.

• A final number of 22 studies were included in the review.   
• Sample range across studies was 1,409 participants, with a range of 12–287.
• Mean participant age was 55 years.
• Women with breast cancer represented 86% of the sample.

Multiple phases of care

Among nonrandomized studies, overall effect size for anxiety was 0.60 (Hedges’s g, p < 0.001) and 0.42 (p < 0.001) for depression. Among randomized controlled trials, effect size for anxiety was 0.37 and 0.44 (p < 0.001) for depression. Most studies used the Profile of Mood States scale or the State-Trait Anxiety Inventory. The range of Jadad quality scores was 0–4, with only six studies having scores greater than 2. This score indicates low quality. Heterogeneity among studies was moderate.

Findings demonstrate a low to moderately significant effect of MBT in reducing anxiety and symptoms of depression among patients with cancer. Heterogeneity among studies suggests that findings be viewed with caution.

• Most participants were women with breast cancer. Findings may not be generalizable to males and to other diseases.
• The quality of many of the assessed studies was low. 
• Most studies did not include patients with clinically significant levels of anxiety or depression at baseline.
• Studies were done at various phases in the cancer trajectory, so how the phase of care may have influenced findings is unclear. 
• In general, anxiety and depression symptoms improve over time with no intervention. The research did not consider this fact.

MBT may benefit patients with cancer by reducing anxiety and symptoms of depression. The use of MBT appears to be feasible in cancer care. The low quality of studies in this analysis points to the need for well-designed research on the effects of MBT.

PHASE OF CARE: Active antitumor treatment

The meta-analysis supported the efficacy of mindfulness-based therapies in the improvement of anxiety and depression levels for people with cancer. The authors note that previous meta-analysis of MBSR studies included only 2 of 9 studies that were RCTs. All seven studies included in this analysis were RCTs. MBSR and mindfulness-based art therapy were the most frequently used mindfulness therapies (5 of 7), and all studies reported anxiety and depression scores. Subgroup analysis of the data further supported the effectiveness of mindfulness-based intervention in relieving anxiety and depression across cancer type and stage.

• Lack of consistency in type of mindfulness-based intervention between studies.
• The subgroup analysis indicated that some interventions may be more effective in specific cancer types.
• None of the studies in the this meta-analysis indicated where participants were receiving concurrent medical or somatic treatment for anxiety or depression at the same time as the mindfulness-based interventions.  
• Small number of studies and different forms of cancer in the studies

This meta-analysis supports the effectiveness of mindfulness-based interventions for management of cancer-related anxiety and depression.

To assess the efficacy of mindfulness-based meditation therapy on the anxiety, depression, and spiritual well-being of Japanese patients undergoing anticancer treatment

Researchers used a modified version of the Mindfulness-Based Stress Reduction (MBSR) Program. The modification focused on cyclic mediation (breathing and meditation). Each session lasted 30–60 minutes and was conducted by nurses or a clinical psychologist. The first session consisted of the cyclic mediation program and recommendations to perform the mediation at home once daily, using a CD or DVD. After two weeks the patients met with interviewers and discussed impressions.

• N = 28.
• Females: 24; males: 4.
• Mean patient age was 60 years (SD = 9.2 years).
• Patients' performance status was 0–2, and all patients were able to visit the hospital.
• Primary tumor sites: breast (21), colon (2), stomach (2), bladder (2).

• Single site
• Outpatient
• Japan

Pre- and postintervention questionnaire

• Hospital Anxiety and Depression Scale (HADS), Japanese version
• Functional Assessment of Chronic Illness Therapy—Spiritual (FACIT-Sp), to measure sense of meaning
• Caregiving Consequences Inventory modified to eight items, to measure psychological appreciation
• Benefit-finding scale, to measure pain, constipation, nausea, fatigue, and sleep disturbance by using three items per symptom and ratings on a 0–10 numeric scale

• HADS anxiety score decreased from 6.9 ±3.6 to 5.1 ±3.9 (p = 0.01).
• HADS depression score decreased from 5.1 ±2.9 to 3.5 ±3.1 (p = 0.009).
• Total HADS score decreased from 12 ±5.3 to 8.6 ±6.3 (p = 0.004) after the intervention.
• FACIT-Sp scores increased from 32 ±6.5 to 33 ±6.9 (p = 0.69), a change that was not significant.
• Researchers noted relationships between FACIT-Sp and HADS (r = –0.78, p = 000), FACIT-Sp and growth (r = –0.35, p = 0.04), FACIT-Sp and pain (r = –0.41, p = 0.02), and growth and appreciation (r = 0.45, p = 0.009).

The mindfulness-based intervention as provided in this study was associated with decreased anxiety and depression.

• The study had a small sample size, with fewer than 30 participants.
• The study had no control group and used convenient sampling.
• Study results were not generalizable.
• Methods were not well described.
• Researchers modified the measurement tools, using only some tool items. The researchers presented no information about the validity or reliability that resulted from these modifications.

Nursing interventions that can help reduce the anxiety and depression of cancer treatments need exploration. More studies that result in reproducible measures are needed.

To determine the feasibility and acceptability of mindfulness-based stress reduction to manage the symptoms of fatigue, anxiety, and depression in women with metastatic breast cancer

An eight-week mindfulness-based (Kabat Zinn) stress reduction course was taught by a trained, experienced instructor. The sessions in weeks 1 and 8 were two and a half hours, and week 2–7 sessions were two hours. Week 6 included a day of mindfulness of four and a half hours. Home practice with CDs 30 minutes a day was recommended. Sessions were done in a group setting.

• N = 19  
• AGE RANGE = 37–65 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Metastatic breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Mean years since metastatic breast cancer diagnosis was 2.76; Eastern Cooperative Oncology Group (ECOG) Performance scores 0–2; stable disease; life expectancy at least six months

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: Community oncology center, United Kingdom

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

Mixed method design using qualitative and quantitative data with repeated measures

Qualitative data consisted of interviews one to two weeks prior to the course and four months after the course. Quantitative data consisted of four questionnaires delivered at five time points: the Brief Fatigue Inventory (BFI), the Hospital Anxiety and Depression Scale (HADS), the EuroQol Quality of Life-5 Dimensions, and the Toronto Mindfulness Scale (TMS) at baseline and at weeks 4, 8, 15, and 24. Quantitative data consisted of one questionnaire at two time points: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) at baseline and at week 24.

A group mindfulness-based stress reduction intervention appeared feasible for patients with stable advanced cancer. However, the intervention as used here was time intensive. This type of intervention may be helpful in dealing with some symptoms in patients with advanced disease.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Cost to train mindfulness instructors; time commitment for patients; repeated measures design raises the question of potential testing effect as the same instruments were used repeatedly; no control comparison or attention control study design, so it is impossible to tell how much of the changes seen in anxiety and depression were due to the group interaction rather than the intervention

There is an opportunity to study mindfulness-based stress reduction in patients with metastatic breast cancer and other patients with advanced disease. This study showed that this may be feasible; however, recruitment was difficult, and patients identified barriers related to severity of illness, time commitment, and travel to attend sessions.

To examine the effects of a mindfulness-based stress-reduction therapy (MBSRT) on stress and mood disturbances and to examine the relationship of improved mindfulness and mood changes.

Hospital staff referred patients to the study or patients self-referred to the study. MBSRT consisted of eight weekly sessions and a six-hour silent retreat held after the sixth session. Classes taught participants about the mind-body connection, principles of mindfulness, and yoga practice. Patients were encouraged to share experiences to generate support from group members. All were given CDs with guided meditation exercises, and all received a program manual. Patients were encouraged to practice meditation and mindful movement at least 45 minutes per day. Patients who did not attend at least five sessions were excluded from the analysis.

• The sample was comprised of 268 patients.
• Mean age was 53.8 years.
• The sample was 15.7% male and 84% female; 71% were married or partnered.
• Patients were diagnosed with breast, hematologic, and colon cancer.
• Average time from diagnosis was zero years, indicating participation close in time to diagnosis.

• Single site
• Outpatient
• Canada

Patients were undergoing the transition phase after active treatment.

The study used a pre-/posttest design.

• Mindfulness Attention Awareness Scale (MAAS)
• Five Facet Mindfulness Questionnaire (FFMQ)
• Calgary Symptoms of Stress Inventory (C-SOSI)
• Profile of Mood States (POMS) Questionnaire

• The level of mindfulness increased significantly over the course of the program (p < 0.001). 
• Improvements in stress and mood outcomes were noted, with effects of at least small to moderate size.
• Change was observed in tension-anxiety (d = 0.52), depression (d = 0.44), and fatigue (d = 0.37) (p < 0.001). 
• The study revealed no significant or strong correlation between mindfulness change and mood change.

The findings supported the use of MBSRT approaches for managing the symptoms of anxiety, depression, and fatigue.

• The study had risks of bias:  the sample consisted mostly of self-referred participants, suggesting that participants may have been predisposed to find therapy effective; and the study lacked a control group, blinding, random assignment, and appropriate attentional control condition. The lack of a control condition is particularly important because anxiety, depression, and fatigue can improve over time with no intervention.
• The findings were not generalizable.
• Baseline anxiety and depression scores were not reported, so it is not known if patients had any initial significant mood problems.
• The authors stated that patients who did not attend at least five sessions were excluded from the analysis, but the authors did not report how many patients, if any, were excluded; therefore, the drop-out rate and final sample size were unclear.
• The fact that the study revealed no significant correlations between change in mindfulness scores and mood changes may suggest that the mindfulness aspect of the intervention may not be the main effective component—the component may have been yoga or the support group sessions.

The findings suggested that a stress-reduction intervention involving group support, yoga, and mindfulness may help patients manage the symptoms of anxiety, depression, and fatigue. The various study limitations prevented firm conclusions from being drawn.

To compare effects of a mindfulness-based intervention to those of a psychoeducational telephone consultation on quality of life, depression, fatigue, and anxiety.

The study was begun as a randomized, controlled trial and patients were allocated at random to either the mindfulness-based or psychoeducational groups. Because of patient complaints about group assignment, in the second half of the study, patients were allocated to the group of their choice. The mindfulness intervention was based on mindfulness-based stress reduction concepts and activities and was provided in 2.5-hour group sessions weekly for eight weeks. They also had homework assignments, two 2.5-hour booster sessions at the end of 1 and 2 months during a three-month follow-up phase, and an all-day retreat. At baseline, individuals were interviewed to establish individual goals and, at the end of the program, were interviewed regarding goal attainment, maintenance of acquired skills, and evaluation of personal experience. The comparison group received 15-30 minutes of psychoeducational consultations by telephone twice a month for eight weeks. During the follow-up period, they had additional phone calls at the end of months 1 and 2. Study measures were obtained two weeks before and after the initial intervention and three months postintervention. Consultation with intervention teachers was used to evaluate treatment fidelity.

• N = 62, with 53 completers
• MEAN AGE = 52.1 (SD = 14.1)
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: Patients were at least six months after completion of HCT and in complete remission at the time of enrollment. The mean time since transplantation was 7.5 years. All had hemotologic disease

• SITE: Not stated/unknown  
• SETTING TYPE: Not specified  
• LOCATION: Switzerland

• PHASE OF CARE: Late effects and survivorship

• Quasi-experimental phase and RCT phase

• Profile of Health Related Quality of Life in Chronic Disorders
• FACT scale
• CESD scale
• Fatigue questionnaire
• FACIT fatigue scale
• Spielberger State Trait Anxiety scale
• Goal Attainment assess on 11-point scale from -5 (completely unmet) to 5 (beyond expectation)

Quality of life and depression improved immediately after the intervention (p < 0.02)  At the three-month follow-up, significant differences were noted between groups, with improved quality of life in the mindfulness group (p = 0.04)  and lower depressive symptoms  and anxiety in the psychoed group (p = 0.04). There was no significant effect of either intervention on fatigue. There were no differences in outcomes based on whether the patient was randomly assigned or chose the preferred intervention.

Findings suggest that a mindfulness-based intervention may have positive benefits for overall quality of life and depressive symptoms in the short term, but this study did not show a long-term impact on depression or anxiety. No effect was seen for fatigue.

• Small sample (less than 100)
• Subject withdrawals of 10% or greater 
• Other limitations/explanation: 14.5% attrition in the mindfulness group and 7% in the comparison group. Booster sessions were only attended 50% of the time.

Findings suggest that a group mindfulness-based program for HCT survivors is feasible, although the overall attrition and poor attendance at follow-up sessions suggests it is difficult to maintain involvement in the longer term. Additional study incorporating Web-based and telephonic follow-up boosters might be more practical for patients to attend. Although there were some immediate effects for depressive symptoms, these were not long lasting. Additional research is needed to explore long-term benefits and most effective methods for delivery of this type of intervention.

• To assess the effectiveness of a mindfulness-based stress reduction (MBSR) intervention for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer.
• To compare MBSR to usual care and its effect on mood and disease-related quality of life.
• To measure if a dose-related effect was evident with formal, eight-week MBSR practice.

The intervention consisted of an eight-week MBSR program closely following the Kabat-Zinn method. The intervention involved 2- to 2.25-hour classes and a 6-hour retreat. Home practice was recommended for 45 minutes, six to seven days per week. Outcomes were measured at baseline, weeks 8 to 12, and weeks 12 to 14. A wait-list control group received usual care.

• A total of 229 patients (100% female) participated.
• Mean age was 49 years (SD = 9.26 years) in the treatment group and 50.1 years (SD = 9.14 years) in the control group.
• Patients had been diagnosed with stage 0 to III breast cancer; 47% had stage II cancer.
• Participants were recruited from The Haven, a charitable day center that provides free psychosocial services for patients with breast cancer. All patients had received an average of 30 hours of support prior to entering the study.

• Single site
• Outpatient
• The Haven, London, England

• Patients were undergoing long-term follow-up.
• The study has clinical applicability for late effects and survivorship.

The study used a randomized, controlled trial design.

• Profile of Mood States (POMS) questionnaire
• Functional Assessment of Cancer Therapy (FACT)–Breast and Endocrine Symptoms 
• World Health Organization (WHO) (Five) Well-being Index

• The study revealed significant differences between the groups in regard to POMS subscale scores (p < 0.001): depression (p = 0.017), anxiety (p < 0.001), anger (p = 0.005), vigor (p < 0.001), fatigue (p = 0.002), and confusion (p = 0.002).
• Participants completed a mean of 19.58 hours (standard deviation = 11.49 hours) of home MBSR practice over eight weeks, or 21 minutes per day. Increased hours of MBSR practice improved POMS scores at T3 for overall mood (p = 0.004), vigor (p = 0.02), fatigue (p = 0.03), and anxiety (p = 0.01). POMS scores improved at T2 and T3 for anger (p = 0.005 and 0.02, respectively), confusion (p = 0.04 and 0.001, respectively), and well-being.

MBSR significantly improved mood and reduced confusion.

• The study lacked an appropriate control group.
• The control group was not attention controlled, which limited the interpretation of between-group differences.
• The setting was unique, and the intervention used many resources, which made implementing and generalizing findings difficult.
• The study had a risk of bias due to lack of blinding.

Although further study is needed to measure MBSR and its impact on depression and anxiety, in this sample, home-based practice was feasible and improved mood. In practice and education, nurses can promote components of MBSR, such as breathing, yoga, relaxation, meditation, seeking support resources, and gentle stretching.

To assess the efficacy of mindfulness-based therapy on pain and distress in women treated for breast cancer

After completing baseline questionnaires, patients were randomized to the intervention or waitlist control group. The intervention was adapted from a standard intervention manual to the use of a shorter two-hour session, shorter meditation exercises, more gentle yoga exercises, and the elimination of all day sessions. The intervention was delivered in groups during eight consecutive weeks. All sessions were facilitated by a trained mindfulness instructor. Study measurements were conducted after the intervention and at three and six months after completion.

• N = 107  
• MEAN AGE = 56.4 years
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: All had breast cancer and the majority had surgery and radiotherapy; 72% were on endocrine therapy. The average time since surgery was 40.6 months.
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-four percent were married or cohabitating, and 45.2% were retired.

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

PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial with waitlist control

• Carlson Comorbidity Index
• Short-Form McGill Pain Questionnaire (SP-MPQ)
• Hospital Anxiety and Depression Scale (HADS)
• Report of pain medication use
• Adherence assessed by sessions attended and time spent on homework via self-report

Pain intensity and neuropathic pain declined over time in the intervention group compared to the control group (p = 0.036). No differences in anxiety or depression over time were reported between groups. The average number of sessions attended was five, and the average amount of time spent on homework was 24 minutes per day. A direct correlation between number of sessions attended (p = 0.01) and time spent on practice (p = 0.01) was reported. The dropout rate was 22% across both study groups; only four dropouts were in the control group.

Participation in the mindfulness-based intervention was associated with a reported reduction in pain intensity; however, a large percentage of those allocated to the intervention dropped out of the study or were lost to follow-up, suggesting that the intervention as provided may not be practical to many patients.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Intention to treat analysis may have overestimated effects—the intervention group had lower pain scores at baseline and had a large percentage of dropouts.

Mindfulness-based group therapy may be helpful in the management of long-term pain with breast cancer but was not shown to have an affect on anxiety or depression over time. The strength of findings in this study is limited because of study limitations.

To compare mindfulness-based stress reduction (MBSR) with psychoeducation/support groups (PES) as interventions to treat cancer-related fatigue (CFR) and associated symptoms of anxiety, depression, vitality, sleep disturbances, and pain. An active treatment control group (PES) was used to determine the effect size of MBSR in reducing CRF.

Breast cancer survivors (BCSs) and colorectal cancer survivors (CRCSs) were blinded and randomized into the MBSR group or the PES intervention. The primary outcome was CRF interference, and secondary outcomes of CRF were severity, vitality, anxiety, depression, sleep disturbances, and pain at baseline (T1), postintervention (T2) and at six months postintervention (T3). Both arms of the study included a structured curriculum that lasted two hours weekly for eight weeks. As the MBSR cohort had required exercises and practice assigned between classes, the PES arm was also given between-session practice and supplemental readings related to class topics. Treatment fidelity to each of the interventions was maintained by use of standardized manuals for each (MBSR and PES), audio recordings of the sessions with review by investigators using checklists created to evaluate the interventions. The MBSR intervention was adapted from standard approaches to eliminate the use of a retreat, the addition of psychoeducation, a brief body scan at bedtime, and shorter home practices. The PES program incorporated group discussions.

• N = 69   
• MEAN AGE = BCS: 56.9 years (SD = 9.9 years), CRCS: 56.4 years (12.7 years)
• MALES: 9.9%, FEMALES: 90.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Adults aged 18 years or older with nonmetastatic (stage 0–III) BCSs or CRCSs who reported CRF as 4 or greater on the Fatigue Symptom Inventory (FSI)
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had completed active treatment an average of 2.4 years prior to the study and were predominantly Caucasian (70.4%). Forty-six percent of the BCSs were on endocrine therapy at the time of the study, and the only statistically significant difference between groups at baseline was income (p = 0.07).

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: National Cancer Institute–designated comprehensive cancer center clinics

PHASE OF CARE: Late effects and survivorship

Single-blind, two-armed, randomized clinical pilot trail

• FSI
• SF-36 Vitality Scale
• Patient Health Questionnaire-8 (PHQ-8)
• Generalized Anxiety Disorder-7 scale
• Patient Health Questionnaire-9 (PHQ-9) for depression 
• Insomnia Severity Index
• PEG three-item abbreviated version of the Brief Pain Inventory (BPI)
• Global Improvement in Fatigue measure was a single item asking participants to rate their CRF compared to the beginning of the study.

The primary outcome of CRF interference did not significantly differ between MBSR and PES, although a trend (insignificant) toward MBSR was observed at T2 (d = –0.46, p = 0.073). Secondary outcome of vitality demonstrated moderate and significant effect size in the MBSR arm compared to the PES arm (d = 0.53, p = 0.003) at T2; however, the between group difference did not last through the T3 measurement. The MBSR maintained improvement in vitality, whereas vitality improved in the PES group. In addition, at T2, the MBSR participants were significantly more likely to report CRF global improvement (58.8 versus 34.3%, respectively, X² (1) = 4.176, p = 0.041). Both groups continued to report similar global improvements in CRF at T3 (MBSR = 45.5 versus PES = 54.3%, X² (1) = 0.53, p = 0.467). Pain was the only between group secondary outcome in which MBSR demonstrated moderate and significant improvement at T3 compared to PES (d = –0.50, p = 0.014).

Within group effects: Both MBSR and PES participants demonstrated moderate to large effects and significant improvements on all fatigue outcomes at T2 and T3 compared to T1. Participants in both groups also reported moderate to large effects and significant improvements at T2 and T3 from baseline in depression (p < 0.001), anxiety (p < 0.001), and sleep disturbance (p < 0.001).

Although the aim of this study was to rigorously test MBSR as an intervention for CRF in preparation for a phase-III randomized, controlled trial, the study supported the strength of PES as an intervention as well.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Findings not generalizable

Although MBSR has been shown an effective intervention for numerous cancer-related symptoms, including CRF, a structured PES intervention was also clearly effective in helping survivors manage fatigue and other symptoms. However, given the more immediate effect of MBSR for participants, MBSR may provide results sooner. Both interventions are efficacious and therefore provide cancer survivors a choice in interventions effective in reducing CRF and its interference in daily life through anxiety, depression, and sleep disturbance.

To determine whether, compared to usual care, a mindfulness-based stress-reduction (MBSR) intervention involving breast cancer (BC) survivors is efficacious in improving psychological and physical status

Patients were randomized into one of two arms: the group receiving MBSR for BC patients (MBSR (BC)) and the group receiving usual care. Assignment to group was random and stratified by stage of cancer and treatment received; if desired, members of the usual-care group were wait-listed to receive the MBSR (BC) intervention. Assessments were completed at an initial baseline orientation and within two weeks of the end of the six-week intervention or control period. Data collectors were blinded to treatment assignment. The MBSR (BC) group received six weekly two-hour sessions led by a single trained psychologist. Class size was 4–8. Subjects received a training manual and four audiotapes to support home meditation practices. Members of the MBSR (BC) group kept a daily diary. Participants completed various activities during the six-week period. The intervention comprised three specific components:

• Educational material related to relaxation, meditation, and the mind-body connection
• Practice of meditation in group meetings and homework assignments
• Discussion, among group members, related to barriers to practicing meditation, application of mindfulness in daily situations, and use of a support group.

• Sample size was 82. Participants were enrolled during the 18-month post-treatment survivorship period.
• Mean patient age was 57.5 years (SD = 9.4 years).
• Of the participants:
  • 100% were female.
  • 70% had been diagnosed with cancer at stage 0 or I; 30%, at stage II or III; and 39% had received chemotherapy in combination with radiation therapy.
  • 30% had hypertension; 10%, diabetes mellitus.
  • 25% were taking antidepressants.

• Single site
• Outpatient
• H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

Transition phase

Randomized controlled trial

• Concerns About Recurrence Scale
• State-Trait Anxiety Inventory
• Center for Epidemiological Studies Depression Scale
• Life Orientation Test, six items assessing positive or negative life-outcome expectations
• Perceived Stress Scale-10 item
• Medical Outcomes Study (MOS) SF-36, measuring quality of life
• MOS Social Support Survey, a 19-item measure of social support
• Two Likert-scaled items widely used in epidemiologic research to measure spirituality
• MD Anderson Symptoms Inventory, which measured self-reported symptoms

• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had significantly lower adjusted mean levels of
  • depression (6.3 versus 9.6, p = 0.03).
  • anxiety (28.3 versus 33.0, p = 0.03).
  • trait anxiety (30.4 versus 34.5, p = 0.004).
  • fear of recurrence (9.3 versus 11.6, p = 0.007).
  • recurrence concerns (26.7 versus 36.5, p = 0.01).
• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had higher
  • energy (53.5 versus 49.2, p = 0.02).
  • physical functioning (50.1 versus 47, p = 0.01).
  • physical role function (49.1 versus 42.8, p = 0.03).
• In stratified analyses, subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning.
• Adjusted mean scores at six weeks—for social support, perceived stress, optimism, and spirituality—did not differ by treatment assignment.

Compared to usual care, the six-week MBSR (BC) program for BC survivors, within 18 months of treatment, resulted in significant improvements in psychological status and quality of life.

• The study had a small sample size, with fewer than 100 participants; therefore, the study was underpowered. Are outcomes sustainable?
• The study did not include long-term follow-up—especially important in this case because fear and anxiety can increase as patients get further from the treatment period.
• The study did not include an attention-only or support group as a control group.
• Only 70% of MBSR subjects were considered intervention-compliant.
• Many outcomes were self-reported using validated measures. Replicating this type of program may not be feasible. The ability to generalize study results is limited.

The symptoms this study addressed continue to be of great concern to patients with cancer. Nurses must know how to help patients with these symptoms during and after treatment. Nurses should explore alternative ways to educate patients about interventions that can improve outcomes.

To compare the prevalence and severity of symptoms and symptom clusters in patients with breast cancer who participated in a mindfulness-based stress reduction (MBSR) program to the symptoms and symptom clusters in patients who received usual care.

Women who expressed interest in participating in the study were randomly assigned to MBSR or usual care. The MBSR program lasted six weeks and included educational material, meditation practice in weekly group settings and homework, group discussion on barriers to meditation, application of mindfulness in daily life, and group support interactions. Meditation training consisted of sitting and walking meditation, body scan, and gentle Hatha yoga. Researchers obtained study measures at baseline and within two weeks of program conclusion. Hierarchical-cluster analysis was used to identify symptom clusters. Researchers compared each group's symptom clusters and individual symptoms to those of the other group.

• In total, 84 participants (100% female) were included.
• Mean patient age was 58 years (standard deviation = 9.4 years).
• Median time since diagnosis of breast cancer was 11 to 15 weeks.
   

• Single site
• Outpatient
• Florida

This was a randomized, controlled trial.

MD Anderson Symptom Inventory

Severity of symptoms declined in both groups from baseline to the end of the study. Fatigue and drowsiness declined more in the MBSR group (p = 0.05). Interference scores for mood and relationships also declined more in the MBSR group (p ≤ 0.05). Analysis of changes in symptom clusters showed no differences between groups. Clusters identified were gastrointestinal (nausea, vomiting, anorexia, shortness of breath, dry mouth, numbness), cognitive or psychological (distress, sadness, pain, remembering), and fatigue (fatigue, disturbed sleep, drowsiness). Cluster scores declined in both groups.

Findings suggested that MBSR interventions may benefit women with breast cancer who are managing fatigue or mood.

• The study had a small sample size, with less than 100 participants.    
• Baseline sample/group differences were of import.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The control group included significantly more black patients than did the MBSR group. Ethnic and cultural differences could impact the findings.
• The study did not state whether any patients were receiving antitumor treatment or if any patients had undergone surgery.
• The gastrointestinal cluster did not make clinical sense as a cluster. 
• Enrollment occurred by means of patient self-selection.
• Symptom severity scores at baseline were low in all patients (less than 4 on a 10-point scale).

Findings suggested that MBSR may be helpful, to some patients with breast cancer, as a means of combating fatigue and mood changes. Study limitations limited the strength of these findings.

To assess the impact of an eight-week mindfulness-based cognitive therapy program on individuals experiencing distress as a consequence of cancer 

Participants included people with a history of cancer and those the study defined as carers. Participants were people who called the Cancer Council South Australia Helpline. They were assessed for anxiety and depression before and after a course of mindfulness-based cognitive therapy (MBCT). The MBCT program consisted of eight weekly two-hour sessions facilitated by an experienced counselor. The program sessions included these topics: stepping out of automatic pilot; dealing with barriers; mindfulness of one’s breath; staying present; acceptance; holding, allowing, letting be; thoughts are not facts; how to best take care of oneself; and using learned skills to control future mood. An optional three-hour follow-up session occurred six weeks after program completion, to reinforce mindfulness principles.

• The sample (N = 21) included 16 cancer survivors and five carers.
• Mean participant age was 52 years, with a range of 34–69 years.
• The sample was 14% male and 86% female.
• The largest number of participants had breast cancer; glioblastoma multiforme, adenoid cystic carcinoma, acute myeloid leukemia, lymphoma, liver cancer, bladder cancer, ovarian cancer, and prostate cancer were represented.
• Time since diagnosis was 3–120 months.

• Single site  
• Adelaide, South Australia, Australia

• Patients were in the transition phase after initial treatment.
• The study has clinical applicability for late effects and survivorship.

Prospective, one-group, pre/post-test design

• Beck Depression Inventory (BDI)    
• State-Trait Anxiety Inventory (STAI)
• Freiburg Mindfulness Inventory (FMI)

• Mean depression scores decreased from mild (mean: 15.0; SD = 9.07) to minimal (mean: 10.37; SD = 5.92) and for anxiety levels from clinical (mean: 43.17; SD = 13.25) to nonclinical (mean, 31.39; SD = 9.61). 
• At the three-month follow-up, depression levels remained roughly the same as they had been at baseline. Compared to pretreatment levels of mean anxiety, at three months researchers noted a slight but nonsignificant increase.
• Mindfulness level at each time point had significant negative correlations with depression and anxiety.

Poor study design and small sample prevent drawing a valid conclustion about the effect of the intervention.

• The study had a small sample size (particularly in regard to carers), with fewer than 30 participants. This fact limits generalizability.
• The study did not include an appropriate control group.
• The authors' recruitment method, using those who had called a helpline as the recruitment pool, was unusual. 
• Defining and measuring the concept of mindfulness is difficult.
• Measurement and intervention time points, in relation to cancer treatments, were unjustified; thus, the findings may have been the result of natural changes over time.
   

MBCT may be an effective intervention for cancer survivors and carers who are willing to make a time commitment for sessions and homework. Further research is warranted.

To test, in a randomized controlled study, the effect of a structured eight-week group mindfulness-based stress-reduction program on anxiety and depression among women with breast cancer

The mindfulness-based stress-reduction program consisted of eight weekly two-hour group sessions. The program included guided meditation, yoga and psychoeducational advice on stress and stress reactions, and group dialog about the integration of mindfulness practice into daily life. Three experienced clinical psychologists provided the program. The control group received usual care. Data were collected before randomization and at 6 and 12 months after the intervention.

• The study reported on 336 female patients (168 in the experimental group, 168 in the control group).
• Mean patient age was 54.14 years (SD = 10.30 years).
• Patients had stage I–III breast cancer (97% had stage I or II).
• Recruitment was of patients who had received surgery within 3–18 months. Patients underwent various treatments during the study.

• Multisite
• Outpatient setting
• Hospitals associated with University of Copenhagen, Denmark

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A randomized controlled trial design was used.

• Symptom Checklist-90 Revised (SCL-90-R), Danish version: 13 items relating to the depression subscale and 10 items relating to the anxiety subscale
• Center for Epidemiologic Studies Depression Scale (CESD): 21 items focusing primarily on cognitive and affective, rather than physical, manifestations of depression

• At baseline, researchers noted no difference between groups in regard to clinical or demographic characteristics, depression, or anxiety.
• After intervention, analysis revealed a statistically significant between-group difference regarding CESD scores (p = 0.001). At six months, analysis revealed a significant between-group difference regarding anxiety scores (p = 0.05) and for both depression measures (SCL-90-R, p = 0.01; CESD, p = 0.03). After 12 months, researchers noted a significant difference between groups in regard to SCL-90-R depression and CESD scores. After 12 months, intention-to-treat analyses showed differences between groups in levels of anxiety (p = 0.0002) and depression (SCL-90-R, p < 0.0001; CESD, p = 0.0367).
• The intervention was more effective for those with higher levels of anxiety and depression at baseline.

The mindfulness-based stress-reduction program was effective in reducing anxiety and depression over time in the patients studied. The intervention was most effective for those who had higher levels of anxiety and depression at baseline.

• The study had risk of bias due to lack of appropriate attentional control.
• Key differences between the sample groups could have influenced results.
• The intervention is expensive, impractical to implement, and presents training needs.
• Researchers paid insufficient attention to the control group and provided no blind.
• Patients may have been at different time points in relation to treatment (e.g., chemotherapy, radiation treatment). This may decrease the reliability of study findings.

The intervention appears to be effective. It does, however, require that the facilitator receive special training, which is an extra cost, and the intervention may be difficult to implement in the practice setting. The study does not address whether the effectiveness of the intervention varies with phase of care. As with other types of intervention, the mindfulness-based stress-reduction program appeared to be most effective for patients who had higher levels of anxiety and depression at the beginning of treatment, suggesting that appropriate patient selection for such an intervention can be beneficial. This study was limited by the lack of attentional control; providing attention alone may positively affect the anxiety and depression of patients with cancer.

4,900 references were identified that were published between January 1, 1990 and December 31, 2013. 203 articles were included in the final review although only 174 were referenced. Grades used and reported here were A: recommended, high certainty of benefit, B: recommended, high certainty of moderate to substantial benefit, D: recommends against use, moderate to high certainty of no net benefit, and H: recommends against use, moderate to high certainty that harms outweigh benefits.

Interventions for specific symptoms that had strong recommendations for or against use were:

• Anxiety: Music therapy during RT and chemotherapy sessions, meditation, and yoga for patients undergoing therapy (B-level recommendation)
• Depression: Mindfulness-based stress reduction for patients undergoing radiotherapy, relaxation, and yoga (level A recommendation); massage and music therapy (level B)
• Fatigue: Energy conservation (level B)
• CINV: Acupressure and electroacupuncture in addition to antiemetics (B level)
• Neuropathy: Acetyl L carnitine was not recommended because of harm (H level).
• Radiodermatitis: Aloe vera and hyaluronic acid cream were not recommended as standard therapy because of lack of effect (D level).

It appears that only specific types of interventions were included, and there are numerous types of integrative or complementary interventions that were not considered in this review. The findings considered were limited to women with breast cancer. Quality rating of evidence was not discussed individually.

These guidelines provided an evidence-based evaluation of various integrative therapies in women with breast cancer. This set of interventions is not all-inclusive; however, it does provide some guidance to clinicians and others regarding evidence strength in these areas as assessed by this specific study group.