Body-Mind-Spirit Therapy/Qigong

Explore whether meditative movement improves cognitive function, quality of life, physical activity, and body mass index (BMI) in postmenopausal women with breast cancer who report clinically significant fatigue.

The intervention included two groups: meditative movement (consisting of Qigong and Tai Chi Easy movements) versus sham Qigong (consisting of similar movements without meditative components), both of which were referred to as rejuvenating movement to blind participants. Participants completed 14 one-hour sessions over 12 weeks with interventionists and were asked to complete 30-minute DVD-guided sessions at home five days per week. Study assessments were done before groups began, at the end of the groups (i.e., 12 weeks post-baseline), and three months after the groups ended.

• N = 87   
• AGE: mean = 58.8 years (SD = 8.94)
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Initial diagnosis of nonmetastatic, invasive breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 91% White, 59% completed some college, stage 0-III, no recurrence or other cancers, 69% on endocrine therapy, completed adjuvant chemotherapy and/or radiation therapy six months to five years before enrollment, currently reporting clinically significant fatigue; excluded for moderately severe or greater depressive symptoms, BMI > 32, comorbidities and medications affecting fatigue and sleep, smoking/excessive alcohol consumption, and routine mind-body practices.

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

PHASE OF CARE: Late effects and survivorship

Double-blind randomized controlled trial of meditative movement versus sham control with repeated measures

• Cognitive impairment: Functional Assessment of Cancer Therapy-Cognitive Function (subjective); Digit Span and Letter-Number Sequencing (attention and working memory)
• Other measures: SF-36 for quality of life, Brief Physical Activity Questionnaire

Feasibility: 86% completed the study, adherence to intervention sessions and home practice not reported; no adverse events

Cognitive impairment: No group differences at baseline. Both groups improved in self-reported cognitive function and attention/working memory tests (time effects, p < 0.05), but no differences were found between the groups (no group by time effect).

Other outcomes: No group differences at baseline. BMI decreased in the meditative movement group but increased in the sham control group (p = 0.0048).  All other outcomes showed similar pattern to cognitive impairment (i.e., significant time effects for both groups, but no group by time effects).

This exploratory pilot study suggests that meditative movement does not improve cognitive function more than gentle movement without mindfulness. Although both types of movement may improve cognitive impairment, it is unclear if improvement was due simply to participating in groups.

• Small sample (< 100)
• Measurement validity/reliability questionable 
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: This secondary analysis used data from a larger study not designed to evaluate cognitive function comprehensively. The neuropsychological tests used did not capture all domains of cognitive function. The participants reported very few cognitive problems at baseline (potential floor effect). In addition, the sample size was determined based on primary outcome of fatigue, so whether there was sufficient statistical power to detect differences in cognitive outcomes is unclear. Therefore, definitive conclusions cannot be drawn about cognitive impairment. This single-site pilot study is not generalizable to all postmenopausal women with breast cancer.

Study findings do not support suggesting meditative movement exercises such as Qigong or Tai Chi over other types of gentle physical activity to improve cognitive impairment reported by postmenopausal women with breast cancer. The findings do support future well-powered studies using these types of interventions.

This purpose of the study is to evaluate the feasibility of conducting a three-arm single-blind RCT of an eight-week intervention to improve objectively and subjectively measured cognitive function in breast cancer survivors reporting cognitive complaints.

The study comprised three groups: (a) Qi-gong (Six Healing Sounds form: combination of diaphragmatic breathing, chanting of six healing sounds, and specific gentle arm movements), (b) gentle exercise (gentle arm movements and postures only), (c) attention control (survivorship-focused support group sessions facilitated by a clinical psychologist). Each group met for eight weekly 60-minute sessions. For both the Qi-gong and gentle exercise groups, participants were given instructions to complete 15-minute practice sessions, twice a day, and keep a log. Feasibility was defined by (a) achieving 45 evaluable patients (15 in each group); (b) 75% or greater adherence to weekly attendance for all groups and twice daily home practice for Qi-gong and gentle exercise; (c) 25% or less attrition. Patient-reported outcomes collected at baseline (T1), 8 weeks (T2), and 12 weeks (T3). Neuropsychological testing at T1 and T3 only.

• N = 36   
• MEAN AGE: 54 years (SD = 11.19) 
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Stage I-III breast cancer, 2 months to 8 years after chemotherapy, 52% were treated with radiation therapy, 34% treated with anti-HER-2 therapy, 78% treated with anti-estrogen therapy 
• OTHER KEY SAMPLE CHARACTERISTICS: 90% Caucasian, 90% non-Hispanic/Latino, 88% post-menopausal, mean = 2.3 (SD = 1.65) years post-chemotherapy

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Kansas, USA

PHASE OF CARE: Transition phase after active treatment

Single-blinded three arm randomized controlled trial (Qi-gong/Gentle Exercise/Attention Control)

• Objective cognitive function: Rey Auditory Verbal Learning Test (RAVLT), F-A-S test, TMT-A/B
• Subjective cognitive function: FACT-Cog (perceived cognitive impairment, perceived cognitive abilities, QOL), PROMIS applied cognition (general concerns, abilities)
• Other: MD Anderson Cancer Symptom Inventory (fatigue, sleep disturbance, distress)

Feasibility (primary aim): 36 evaluable patients at T3 (Qi-gong = 15, gentle exercise = 10, Attention control = 11). Adherence was 44%-67% for weekly sessions and 21%-31% for twice-daily home practice. 28% overall attrition rate. 
Cognitive function (exploratory aim): Improvements in self-reported cognitive function, as measured by the FACT-Cog, were significantly greater in the Qi-gong group versus gentle exercise between T1 and T2 (perceived cognitive impairments subscale: p = 0.01, d = 1.14; perceived cognitive abilities subscale: p = 0.04, d = 0.75). No significant differences in self-reported cognitive function were noted between the groups from T2 and T3. Improvements on objectively measured processing speed (TMT-A) were significantly greater in the Qi-gong group versus gentle exercise between T1 and T3 (p = 0.07, d = 1.21). The attention control group improved more than the gentle exercise on the F-A-S test of verbal fluency between T1 and T3 (p = 0.02, d = 1.14). 

Other: QOL improved for all three groups between T1 and T2. Distress significantly improved in the Qi-gong group compared to the support group (p = 0.05, d = 0.81) between T1 and T2. There was no significant improvement in fatigue or sleep disturbance scores.

This study provides support for the design of large studies to confirm the effectiveness of Qi-gong, which combines mindfulness-based elements with gentle exercise, for the improvement of perceived cognitive function and processing speed.

• Small sample (< 100)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Weekly intervention sessions delivered by group leaders trained in six healing sounds form of Qi-gong require specialized training. 28% overall attrition rate (21% for Qi-gong group, 50% for the gentle exercise group and 0% for the attention control group) suggest that some aspects of the intervention may not be feasible.

Interventions that combine mindfulness and gentle exercise, such as Qi-gong, may be feasible for some patients after chemotherapy for breast cancer and may have benefits in reducing cognitive complaints and improving speed in performing mental tasks. However, larger studies are needed to confirm these findings.

To examine the effects of medical qigong on self-reported cognitive function in patients with cancer

Participants were randomized to 10 weeks of medical qigong or usual care. Self-reports of cognitive functioning were evaluated at baseline and at the conclusion of the 10-week intervention. The medical qigong program was a weekly 90-minute group class that included a 15-minute discussion of health, 30 minutes of gentle stretching and body movement in a standing position, 15 minutes of movement in a sitting position, and 30 minutes of meditation and breathing. Two sessions were offered each week; participants could attend one or both of the sessions but had to attend for a minimum of 7 of the 10 weeks. Participants also kept a diary.

• The total number of participants randomized was 81. Fifty-four completed the study, resulting in a 33% drop out rate.
• Participants' mean age was 62 years (SD = 12 years), with a range of 34–86 years.
• The sample was 50% male and 50% female.
• N = 25, colorectal 12%, lung, prostate, gastric, other   
• Forty-two participants received adjuvant treatment, and 36 were receiving metastatic treatment.
• Forty-eight participants completed chemotherapy, and 28 were receiving chemotherapy at the time of the study.
• On average, participants had completed 16.4 years of education (SD = 2.1).
   

• Mutli-site
• Outpatient setting
• University hospitals in Sydney, Australia
   

• Patients were currently undergoing treatment or had completed treatment.
• The clinical applications are for late effects and survivorship.
   

The study was a stratified, randomized controlled trial of a subset of patients from a larger study.

• European Organization for Research and Treatment of Cancer–Quality of Life (EORTC QLQ)–c30, CF version 3 (two items on the cognitive subscale)
• Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog)
   

Participants in the intervention group showed significant improvement in perceived cognitive functioning on both the EORTC QLQ-C30  (p = 0.014) and FACT-Cog  (p = 0.029) compared to the control group (usual care) over time at 10 weeks' follow-up.

Results suggest that medical qigong may improve patients' perception of their cognitive functioning. However, further studies are needed with a larger sample size, objective measures, and longer follow-up to determine whether results are sustainable.

• The sample size was less than 100.
• The 33% drop-out rate was significant.
• Cognitive functioning was self-reported and was not the primary endpoint.
• Attentional control was not used.
• The study was not blinded and therefore had an associated risk of bias.
   

The study suggests that qigong may be beneficial in improving cognitive function in patients with cancer. However, the drop-out rate was significant at 33%. Drop outs occurred for multiple reasons, but it shows that qigong may not be a realistic intervention for some patients with cnacer. Further studies on the specific impacts qigong has on cognitive ability need to be conducted.