Meditation

To evaluate the psychological effects of presurgical stress management training

Subjects were randomized to the intervention or control group by week in the hospital. The intervention consisted of four sessions of meditative exercises, relaxation, guided imagery, and counseling to promote active coping and positive attitude. Sessions were completed on days 5 and 1 before surgery and days 2 and 30 postsurgery. Patients were given a CD with the same instructions to use at home. Assessments were done on days 6 and 1 before surgery and days 2, 5, 30, and 90 postsurgery. The control group received usual care.

• N = 70
• MEAN AGE = 52 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; all stages undergoing surgery; most had lumpectomy

• SITE: Single-site
• SETTING TYPE: Multiple settings
• LOCATION: Netherlands

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)
• Profile of Mood States (POMS) scale for fatigue and depression
• Subjective sleep quality scale
• Numeric Pain Rating Scale (NRS)

Anxiety decreased after surgery in both groups. Depression decreased in the intervention group after surgery and in the control group at three months postsurgery. Depression was significantly lower in the intervention group on day 5 after surgery (d = 0.47). Fatigue increased in the control group and was significantly higher than baseline at three months postoperatively. In the intervention group, fatigue decreased and was significantly below baseline at days 2 and 5 postoperatively. Sleep problems and pain did not change in either group. Across all study timepoints, differences between groups were inconsistent. Sometimes, symptoms were higher in the intervention group, and other times, they were lower in the intervention group. An analysis was done for changes from baseline for each group rather than between groups. There were only differences in the degree of change from baseline to postoperative days 2 and 5.

The effects of the intervention were inconsistent over time and appeared to be modest and short-lasting.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: Though small, the power analysis showed that the sample was sufficient to detect moderate effects. Baseline depression and fatigue levels were much higher in the intervention group, suggesting floor effects in the control patients. Six repeated measures could produce testing effects. There was no information about how often patients used the CDs at home. No information regarding other known intervention variables, including any adjuvant treatment during the study period, was provided.

The findings here were somewhat confusing and inconsistent over time; however, there were some potential short-term benefits for fatigue and depression. The combination of relaxation therapies and counseling is a low-risk intervention that may be helpful for some patients.

Investigate the effects of meditation on the symptoms of anxiety, depression, and fatigue in women who were receiving radiation therapy for breast cancer

The intervention group received a total of 12 meditation therapy sessions during its six-week radiation therapy period. The control group received only conventional radiation therapy. The meditation intervention was Brain Wave Vibration meditation, which is based on a Korean traditional exercise, simple movements, music, and positive messages (changing weekly). This focuses on the senses of the body, relaxing the body and mind and relieving negative thoughts through natural rhythmic movements.

• N = 83    
• MEAN AGE = 47 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Female patients with breast cancer undergoing breast conservation and radiation therapy with curative intent
• OTHER KEY SAMPLE CHARACTERISTICS: Primarily married, primarily financially stable, primarily HER-2/neu negative

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Asan Cancer Center, Seoul, Korea

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Revised Piper Fatigue Scale
• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Patients who received meditation therapy saw mild improvements, with a reduction in anxiety and fatigue. Patients in the control group also showed significant reduction in fatigue and anxiety, and post-intervention scores actually were lower for both of these in the control group. No effect was seen for depression.

The study states that an “affirmation” can be made that meditation can be used as a non-invasive intervention for improving fatigue and anxiety. However, results showed significant reductions in these symptoms for patients in the control group as well. This provides minimal support for effectiveness of the approach used here.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Korean study, using a Korean meditation technique; likely not generalizable to the United States
• Big impact on time
• Not a billable service; great staff time and training involved
• Unclear whether the meditation was in a group setting or individual; what relation did group dynamics play in a group of patients who may have met together 12 times and formed an effective peer-to-peer support group?
• The study was underpowered by the author's calculations.
• An intent to treat analysis was used, but how this was applied was not stated.

Nurses likely would not have any options of referral to meditation resources. Something more generalizable, like relaxation or mindfulness, would have been a better option for a study. The study is Korean; typically educated Korean women may have had previous exposure to meditation, and the intervention would be more acceptable to them than to American women.

To evaluate the effects of mediation group classes on patient and caregiver self-reported symptoms

This was an observational pilot that studied participants (patients and their caregivers) attending any of the three mediation group classes offered at a comprehensive cancer center. Classes were based on Tibetan mind-body mediation tradition, and spanned either 60 or 90 minutes in length, depending on type of class—power breath, sacred sounds, or movement and breath. Instructors of each mediation class consisted of mind-body therapists with at least five years of oncology experience. Participants completed a pre- and post-class Edmonton Symptom Assessment Scale (ESAS). Because participants could attend more than one meditation class, only data from the first visit of the 142 participants was examined. Data obtained from the ESAS was used to analyze symptoms individually and as subscales.

• N =142 (76 patients and 66 caregivers)   
• MEAN AGE: For patients: 57.5 years; for caregivers: 57.6 years
• MALES: Patients: 19.7%; caregivers: 22.7%  
• FEMALES: Patients: 80.3%; caregivers: 77.3%
• CURRENT TREATMENT: Participants spanned cancer continuum from prevention, active treatment, survivorship, or living with advanced cancer
• KEY DISEASE CHARACTERISTICS: Patient diagnoses included: breast (38.2%), hematologic (10.5%), skin (10.5%), thoracic/head and neck (9.2%), gastrointestinal (6.6%), gynecological (6.6%), and other (18.4%). Cancer staging included: local (56.6%), advanced (15.8%), and unstaged (27.6%)

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: MD Anderson Cancer Center (Houston, Texas)

PHASE OF CARE: Multiple phases of care

Observational pilot that analyzed self-reported symptom information from patients and caregivers attending medication classes offered at a comprehensive cancer center between May and December 2015

ESAS was completed by participants before and after classes. Symptoms of the ESAS were analyzed both globally (subscales) and individually. ESAS subscales were scored as follows:

1. Global Distress Score (GDS) as sum of pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath (0-90)
2. Physical Distress Score (PHS) as sum of pain, fatigue, nausea, drowsiness, appetite, and shortness of breath (0-60)
3. Psychological Distress Score (PSS) as sum of depression and anxiety (0-20)

Clinically significant reduction of an individual symptom was defined as > 1; for ESAS global distress score (GDS) > 3; for physical distress score (PHS) > 2; for psychological distress score (PSS) > 2. Higher scores represented worse outcomes for the stated symptom or subscale.

For all participants there was a clinically and statistically significant decrease (improvement) in symptom of shortness of breath (mean = -1.2; p = 0.001), global distress (-5.17, p < 0.0001), fatigue (-1.34, p < 0.0001), anxiety (-1.26, p < 0.001). For patients, there was clinically significant improvement in dyspnea (mean = -1.12; p = 0.013). No clinically significant symptom change was observed when comparing class duration (60- versus 90-minute class). There was no clinically significant difference in participant symptom burden at baseline or in score reduction by group, or by attendance of one versus two or more classes.

Group mediation class, when used in conjunction to standard of therapy, shows a possible subjective improvement in shortness of breath, global distress, well-being, fatigue, and anxiety in the oncology population, but more research is warranted.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: A limitation to the use of mediation classes for symptom reduction in the oncology population is the need/cost for training such techniques as described in the study. The instructors of the meditation classes described in this study were mind-body practitioners with at least five years of oncology experience, and the institution already had a long-established integrative medicine program that was offered to patients on a rolling basis as part of standard of care by clinicians. Generalizability of the population is limited because of the fact that participants were self-selected and not randomized to meditation class. Also limiting generalizability was the fact that participants were of variable staging, cancer diagnoses, care spectrum, and caregivers. There was also no account for participants who may have attended a meditation class prior to the study period or engage in self-practice. For self-reported symptoms, the longitudinal effects of attending regular meditation class has not been examined. Assessments were immediately pre- and post-intervention, so it is unknown if there are any long-term benefits of meditation in this population.

Further research on the long-term effects and continued use of group meditation on shortness of breath is warranted.

Test the effect of Tibetan sound meditation on cognitive function

Patients randomly were assigned to the treatment group or a wait list control group. The intervention consisted of 12 meditation sessions that were 60 minutes long and incorporated instructions on developing breathing, awareness, and concentration skills, as well as visualization maneuvers. The intervention was offered twice a week over six weeks. A CD recording and printed materials were provided to the participants with the expectation that they practice the intervention independently at home. Objective and subjective outcome measures were evaluated at baseline and one month after completion of the intervention. Subjective measures also were completed during the last week of the intervention. Class attendance and participant satisfaction were tracked to measure the feasibility of the intervention program.

• N = 42 (18/24)  
• MEAN AGE = 53.6 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All subjects had breast cancer, had received chemotherapy 6–60 months prior to study participation, and were on hormonal therapy at the time of enrollment.
• EDUCATION: Some college or higher: 95.6%, TSM: 74.9%

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: MD Anderson Cancer Center

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Late effects and survivorship  

Randomized clinical trial

• Digit span test
• Digit symbol test
• Controlled Oral Word Association Test
• Rey Auditory Verbal Learning Test
• Functional Assessment of Cancer Therapy (FACT)-Cog
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Pittsburgh Sleep Quality Index (PSQI)
• Brief Fatigue Inventory (BFI)
• Medical Outcomes Study 36-item (SF-36)
• Functional Assessment of Chronic Illness Therapy—Spiritual Well-being Scale (FACIT-Sp)

No significant differences were seen between the intervention or control groups in either objective or subjective measures of cognitive function over time. Although significantly less depressive symptoms were found in the treatment group (p = 0.05) during the last week of the intervention, this effect was no longer significant one month later, indicating that the result was not sustainable. No significant differences between groups over time were found for fatigue or sleep-wake disturbances. Although all treatment group participants attended at least 50% of the class sessions, compliance was a variable for both class and individual participation.

Findings from this study do not provide clear support for a significant effect of Tibetan sound meditation on cognitive function, fatigue, or sleep-wake disturbances. However, this intervention may have a limited, short-term effect on decreasing depression.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Feasibility may be an issue, as evidenced by subject withdrawal prior to the initiation of the intervention (may indicate that the “treatment” is too burdensome) and the variability in overall treatment participation. Generalization of the result to all patients with cancer is not possible due to the population used for the study.

Although this treatment was not associated with improvements in objective or subjective measures of cognitive function, it was underpowered and lacking consistent patient compliance with the intervention. Further research with larger sample sizes may be warranted to determine effectiveness.

The purpose was to examine effects of mind subtraction meditation on depression and other aspects of well-being.

Patients were randomized to groups receiving meditation or an active control of self-management education. The meditation group participated in sessions twice weekly for two hours over eight weeks. The first four sessions included self-management education, and full meditation began during the fifth session. Group members were sent texts and emails to encourage home meditation twice per week. The education group had two-hour sessions weekly for four weeks, including information on relationships, communication, managing stress, and comfort. Study assessments were done at baseline and weeks 4 and 8.

• N = 52; 48 assessed at week 8   
• AGE: Mean 48.44 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Mean time since surgery was 9 months; most had chemotherapy and endocrine therapy.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: South Korea

RCT with active control

• CES-D for depression
• Beck Anxiety Inventory
• FACT-Breast – quality of life
• Satisfaction With Life Scale
• Pittsburgh Sleep Quality Index – Korean version
• Posttraumatic Growth Index

There were no differences between groups at week 4. At week 8, there were significant group differences in depression (p = 0.034), perceived stress (p = 0.009), anxiety (p = 0.036), as well as other measures. Before meditation, 90% of those in the meditation group reported sleep problems, and after the intervention, 9.1% reported problems. Evaluation of change in sleep quality showed more in the meditation group reported improvement and none reported worsening sleep quality over the eight-week study period (p = 0.010). Attendance in both groups ranged from 75% to 100% of the sessions.

Participation in meditation resulted in improved symptoms of depression and anxiety and improvement in sleep quality.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: It is not stated whether sessions were done in a group setting, in which case, group interaction and support could have affected results. The education group received much less attention.

Meditation may be beneficial for patients to improve sleep and reduce symptoms of anxiety and depression. Additional evidence beyond this study is needed to evaluate these effects.