Mindfulness-Based Stress Reduction

The mindfulness-based stress reduction (MBSR) intervention was provided over eight weekly 90-minute group sessions. Details of the intervention have been previously described in Carlson et al. (2003). Participants were asked to complete 45 minutes of meditation homework six days a week and recorded their progress in a homework log. Patient outcomes were assessed at baseline and at week 8.

• N = 63
• MEAN AGE =54 years
• AGE RANGE = 32–78 years
• FEMALES: 78%
• KEY DISEASE CHARACTERISTICS: Patients with cancer—cancer diagnoses were varied, with the most common being breast (59%), followed by prostate, ovarian, and non-Hodgkin lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants was married (71%) and well educated (mean = 16 years of formal education)

• LOCATION: Tom Baker Cancer Center

• Pre-post intervention study

• Profile of Mood States (POMS)

The MBSR intervention resulted in a statistically significant improvement in fatigue when comparing pre- and post-test outcomes (p < 0.001). Statistically significant relationships also were found between changes in symptoms of stress and fatigue (p < 0.001), as well as changes in mood disturbance and fatigue (p < 0.001). Therefore, with less fatigue, patients also were less stressed and less moody.

• Lack of a control group
• Cannot determine which aspects of the intervention led to observed improvements in fatigue because MBSR is delivered in a multimodal format
• Lack of a specific measure to assess fatigue
• No follow-up assessment; therefore, long-term effects of MBSR remain unknown

Didactic, inductive, and experiential modes of learning were used to implement the intervention and convey information to patients. The intervention was provided over the course of eight weekly 90-minute group sessions (maximum of 15 participants per group) as well as a three-hour silent retreat on Saturday between weeks 6 and 7.

Patients received a booklet containing information about each week’s instructions as well as an audiotape with sensate-focused body scan meditation on one side and a guided sitting meditation on the other.

The program was composed of three primary components.

1. Theoretical materials related to mindfulness, relaxation, meditation, and the mind-body connection
2. Experiential practice of meditation and yoga during group meetings and home-based practice
3. Group process focused on problem-solving concerning obstacles to effective practice, daily applications of mindfulness, and supportive interaction between group members

• N = 59
• MEAN AGE = 54.5 years
• KEY DISEASE CHARACTERISTICS: 49 women with breast cancer and 10 men with prostate cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Most patients (N = 42) were married or cohabiting, with a mean of 14.7 years of formal education. Patients had a median cancer diagnosis of 1.1 years prior to study enrollment (range = three months to 20 years). Two-thirds had stage II cancer (62.7%).
• EXCLUSION CRITERIA: Treatment with chemotherapy, radiation therapy, or hormone therapy currently or within the past three months; psychiatric illness; a concurrent autoimmune disorder; and past participation in a mindfulness-based stress reduction (MBSR) group
• RECRUITMENT: Patients primarily were recruited with pamphlets and posters around the center, in each of the breast and prostate clinic areas, and were able to self-refer.

• LOCATION: Tom Baker Cancer Center

• PHASE OF CARE: Active treatment

• Pre-post intervention study

• European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
• Profile of Mood States (POMS)

The MBSR intervention did not result in a significant difference for fatigue outcomes between pre- and post-intervention time points. Only 42 patients had complete data for both time points. When comparing the 17 patients with incomplete data to the rest of the sample, participants with complete data were more likely to be married or cohabitating. Non-completers had higher scores than completers on several of the baseline measures for POMS subscale, including depression, anger, and confusion.

• Lack of a neutral comparison group
• Lack of correction for multiple comparisons during statistical analysis

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 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.

The MBSR intervention emphasized the following.

• Learning to meditate
• Systematic monitoring of the body
• Exploring one’s limits and trying to shift these limits
• Recognizing and investigating thoughts and cognitions
• Recognizing daily stress inducing conditions and their emotional impact
• Learning more ways to handle daily stress

The intervention was offered in eight weekly sessions that were each 2.5 hours in length. Participants were encouraged to practice at home for 45 minutes using an exercise CD and other homework assignments. Each training group was guided by two therapists experienced in working with patients with cancer. Outcomes were assessed at baseline, at week 8, and a year after intervention.

The intervention was modeled after the MBSR program at the Stress Reduction and Relaxation Clinic, Massachusetts Medical Center as described by Kabat-Zinn (1990).

• N = 47
• MEAN AGE = 48.4 years
• AGE RANGE = 31–65 years
• MALES: 72%
• KEY DISEASE CHARACTERISTICS: Patients with cancer with multiple diagnoses, the most common being breast cancer (40%)
• OTHER KEY SAMPLE CHARACTERISTICS: Undergoing treatment (e.g., chemotherapy, hormonal therapy, radiation treatment, surveillance, alternative/complementary) throughout the intervention period.

Not described

• PHASE OF CARE: Active treatment

• Pre-post intervention study

• Profile of Mood States (POMS)

The MBSR intervention did not significantly improve fatigue outcomes for patients at the eight-week intervention end-point or at one-year follow-up.

• Lack of a neutral comparison group
• Observed changes in quality of life may be a consequence of the passage of time.
• Participants were self-referred to program.
• High dropout rate observed throughout the study (no significant differences in demographic characteristics, disease variables, and well-being scores observed between completers and non-completers)

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 effectiveness of a group mindfulness-based stress reduction program on fatigue severity and life quality measures in women with breast cancer

The intervention was a standard mindfulness-based stress reduction program consisting of mindfulness skills, meditation, relaxation, and yoga. The program was provided in a group setting once weekly over an eight-week period. Patients randomly were assigned to the intervention or control group, which received no intervention. Patients were excluded from the analysis if they did not want to continue to participate in the intervention or missed more than two sessions.

• N = 24  
• MEAN AGE = 43.6 years (range = 30–55 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer and were receiving chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: None provided

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

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, trial 

• Fatigue Severity Scale (FSS)
• Global Quality of Life in Cancer Patients (GLQ-C30)
• Life Quality in Breast Cancer (QLQ-BR23)

Role, emotional function, social function, and cognitive function improved over time in both groups. Pain and fatigue declined over time in both groups (p < 0.001). There was a significant effect of group assignment over time with greater improvements in the intervention group for fatigue and pain (p < 0.001) as well as multiple areas of functioning.

Mindfulness-based stress reduction may be helpful in the management of fatigue among women receiving treatment for breast cancer.

• Small sample (< 30)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: No information was provided regarding adherence to sessions or drop-outs during the study.

Mindfulness-based stress reduction may be helpful for patients with cancer in the management of fatigue and some aspects of quality of life. Additional research involving the use of therapy interventions provided in groups should include appropriate group and attention control conditions because these factors can be expected to have an effect on perceived symptom severity.

The mindfulness based stress reduction (MBSR) intervention was based on the main principle that purposeful management of awareness can be used repeatedly in the ongoing process of adapting to illness once experiential knowledge of key processes in the stress-response cycle is mastered. Objectives of program were to

1. Provide an opportunity to develop an understanding of one’s personal responses to stress and a means to modify them
2. Allow group member to take an active role in their healing process
3. Teach options for self-care that promote feelings of competence and mastery
4. Enhance feelings of well-being
5. Provide a safe and supportive group environment.

The intervention consisted of seven 90-minute weekly sessions. Patient outcomes were evaluated at baseline and at week 7 (end of intervention).

• N = 90 
• MEAN AGE = 51 years
• KEY DISEASE CHARACTERISTICS: Patients with cancer with multiple diagnoses and stages, with breast cancer being the most common (38%)
• OTHER KEY SAMPLE CHARACTERISTICS: Well educated with a mean of 15 years of formal education, convenience sample

• Randomized wait-list control design
  • MBSR (N = 53)
  • Wait-list control (N = 37)

• Profile of Mood States (POMS)

The MBSR intervention did not have a significant effect on improving fatigue outcomes for patients. When comparing pre- and post-test intervention scores, both the control and intervention groups experienced a decline in fatigue scores from baseline to week 7; however, this difference did not reach significance for either group.

In the initial sample of 109 patients enrolled in the study, 19 dropped out. A dropout analysis was performed, and initial POMS scores of dropouts were found to have significantly more mood disturbance on the subscales of anxiety, depression, fatigue, and total mood disturbance (p < 0.05).

• Because MBSR was a multi-component intervention, it is difficult to isolate the mechanisms of action or specific techniques they contributed to the improvements observed.
• It is possible that those assigned to the waitlist control group felt disappointment and may not have improved as much spontaneously over time as they would have otherwise.
• Because the dropout group demonstrated higher mood disturbance, the MBSR program may not be sufficient to treat patients with more serious disturbances.

To evaluate the efficacy of group mindfulness-based cognitive therapy (MBCT) in reducing fatigue in cancer survivors with mixed diagnoses.

Randomization and assignment to either the intervention condition or the wait-list condition was performed one week prior to the start of each group. Fatigue severity (Checklist Individual Strength [CIS]), functional impairment (Sickness Impact Profile [SIP]), and well-being (Health and Disease Inventory) were assessed before and after the nine-week intervention. The intervention group had a follow-up six months after the intervention.

Eighty-three patients (32% male, 68% female) were included. All cancer types were included; more than half of the patients had breast cancer. Three patients had a history of two types of cancer. 

Patients were included if 

• Completion of their last anticancer treatment (all cancer types accepted) was at least one year prior
• They were curatively treated
• They were 18 years or older
• They scored 35 or greater on the severity of fatigue subscale of the self-report CIS
• There was no other somatic disease or medicine use that could explain or influence fatigue. 

Patients were excluded if they were seen on intake by one of two therapists for assessment of psychiatric morbidity or if they were identified to be at risk for psychosis or severe depression.

• Single site   
• Helen Dowling Institute, Netherlands

• Patients were undergoing the long-term follow-up phase of care.
• The study has applicability for late effects and survivorship.

The study used a pre- and postrandomized, controlled trial design.

• CIS   
• SIP
• Health and Disease Inventory
• Sleep Quality Scale (SQS)
• Hospital Anxiety and Depression Scale (HADS)
   

Ninety-one percent of all participants attended at least seven sessions; the mean number of sessions attended was eight. One-third (30.6%) of all participants suffered from sleep disturbances at follow-up, and 39% in the intervention group showed clinically relevant improvement in fatigue severity. Fatigue severity postintervention was 35.7 in the intervention group compared to 43.4 in the control group (p = 0.00). The effect size for fatigue was 0.74 (d) (no confidence interval was provided for effect size). The mean well-being score at postmeasurement was significantly higher in the intervention group than in the wait-list group. Six months after the intervention, participants in both groups reported significantly less fatigue severity. There was no difference between groups in fatigue at six months.

MBCT was effective in the short term for chronic cancer-related fatigue (CCRF). Longer-term follow-up showed no differences with mindfulness-based stress reduction versus the controls.

• The study lacked an appropriate control group.
• The study had limited generalizability to other therapists, as the same two therapists led all groups.
• The protocol that the therapists used was not assessed for adherence.
• There were unequal numbers of participants in the two condition groups.
• Heterogenicity of the sample and the small sample size limited the control of confounding medical variables.
• Limited economic resources exist for program development in support of a standardized practice for therapist-led sessions at local cancer centers. 
• The study lacked an attentional control. 
• Timing of the first posttest measure was not stated, so it was not clear if any effects were lasting.

MBCT is an acceptable and potentially effective treatment for CCRF. Additional better randomized, controlled trials of the intervention should be conducted prior to routinely referring to MBCT therapists.

PHASE OF CARE: Late effects and survivorship

Adapted from three guidelines by multidisciplinary experts using supplementary evidence and clinical experience. Most recommendations listed verbatim but some modified to include updated evidence or current practice beliefs.

Recommendations focused on patients who have completed active treatment or are considered in clinical remission. Treat underlying causes, moderate physical activity after cancer treatment with PT and lymphedema referrals as needed (meta-analysis, systematic review, [randomized controlled trial [RCT]; 10 cited), cognitive behavioral therapy (meta-analysis, RCT, systematic reviews; 6 cited), psychoeducational therapies (systematic, RCT; 3 cited), psychosocial services, mindfulness-based interventions (RCT; 3 cited), yoga (RCT; 2 cited), acupuncture (RCT; 2 cited), psychostimulants/wakefulness agents (limited evidence in patients who are post-treatment disease-free). Additional areas in which research needed include biofield therapies, massage, music therapy, relaxation, Reiki, Qigong, ginseng, and vitamin D.

Guidelines were tailored to survivors with current evidence as not all evidence done is survivors.

Screening, assessment, and treatment guidelines summarized for use in cancer survivors.