Electronic Supplementary Material A

Eligibility Measures and Development and Delivery of the Protocol

  1. Measures. Additional detail is provided in this section on the eligibility screening procedures and measures, and the assessments used for stratification.

A.1. Eligibility screening measures

Fatigue. Potential participants were first screened for fatigue. To be eligible for the study required a score of 50 on the 4-item Vitality scale of the Medical Outcomes Scale short form (SF-36), [1] with this score shown to be validated as a clear marker of fatigue in relationship inflammatory to biomarkers. [2]

Depression. ThePatient Health Questionnaire-9 (PHQ-9) was used to rule out major depression. This brief self-reported depression scale contains 9 items querying the past 2 weeks of experience on a Likert-style frequency. Scores can range from 0 (absence of any depression-related symptoms) to 27 (major clinical depression). PHQ-9's internal reliability is excellent with a Cronbach's alpha score= 0.89. A score of 15 (considered moderately severe depression) [3] or higher was set; only one participant rated above 15 and was referred for psychiatric evaluation.

BMI was assessed using clinical weight scales and height measurements, calculated using the standard Body Mass Index formula. BMI 32 excluded potential participants from the study.

Prior experience with meditative movement. Practice of Meditative Movement (i.e., Qigong, Tai Chi, or Yoga), including a focus on the breath and meditative states was assessed. Regular practice of any of these (defined as 2-3 times per month over 2 or more months) was exclusionary for study participation because having had prior experience could have influenced the way women practiced the exercises in the control group, thus contaminating that arm of the study with habits of slow deep breathing or meditative states while performing.

A.2. Assessment of factors used for stratified randomization

Level of Physical Activity. The Women’s Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ) is a self-report instrument used in the Women’s Health Initiative study of breast cancer survivors and was shown to have high correlation with accelerometry (0.73) and comparable validity, sensitivity and measurement bias compared to the widely accepted Physical Activity Recall (PAR) [4].

This instrument was used to assess initial level of physical activity (PA) to determine high and low categories for stratification (based on prior data establishing a mean of 8.4 MET/hours/week for fatigued breast cancer survivors) [5].

Estrogen suppressive therapies (EST). EST was queried as part of the assessments of medications used. Participants were classified as using or not using EST as a stratification factor in randomization.

  1. Intervention development and delivery

B.1. Development and pre-testing

The intervention protocols were developed by the research team, including an exercise physiologist and a lymphedema expert in the sponsoring cancer center. A set of 10 QG/TCE movements drawn from the Tai Chi Easy [6] practices and the “Vitality Method” series of Qigong exercises [7] were chosen based on the purported properties to improve overall Qi balance, vitality, and mental alertness, to be taught using the principles of Meditative Movement [8].

A similar set of movements was selected by the team from exercises designed for rehabilitation of breast cancer patients. Movements for both the QG/TCE intervention and SQG control included reaching with the arms upward, outwards, sideways, and in arcs; swaying and circling shoulders and hips; and slow, relaxed dance-like flowing movements alternating with a few muscle-tightening, isometric movements.

The two exercise protocols, QG/TCE and SQG, were examined for comparability of movement. The two sets of 10 core exercises were performed by the instructors and rated by three volunteers on the extent of the movements as being (a) flowing or fluid, (b) relaxed, (c) low exertion, and (d) use of slow deep breathing. The ratings were very similar across the two protocols for a-c, but dissimilar for deep breathing, suggesting that the movements and level of exertion would be similar for both, while the sham protocol was missing the focus on breathing, as intended.

B.2. Interventionmaterials and resources

A DVD featuring a set of introductory principles of practice and the 10 core exercises was professionally produced for each intervention protocol, and provided to participants to help guide their practice at home. Participants were also given a written instruction manual for those who preferred to read rather than “watch and listen”. Instructions in the manual, in the live teaching and in the DVD, were scripted to fit the respective interventions, with the QG/TCE teaching emphasizing slow, fluid movements, breathing in rhythm with the motion, and clearing the mind to create a relaxed, meditative experience. The SQG instructions emphasized correct and comfortable positioning of the body, with no reference to breathing, mind-clearing, or relaxation.

B.3. Instructors

The QG/TCE instructor was a registered nurse with certification in Holistic Nursing, and numerous certificates for teaching yoga and meditation. She had a decade of experience in teaching mind-body practices to cancer patients and was trained by co-authors, Drs. Jahnke and Larkey to teach the QG/TCE intervention. The sham QG (SQG) instructor was a professional exercise physiologist, experienced in addressing the concerns of cancer patients in the context of rehabilitation exercises that promote range of motion, flexibility, aerobic fitness, and strength training.

B.4. Class Logistics

Both interventions were scheduled to be completed over a 12-week period, meeting twice a week for the first two weeks to intensify the opportunity to learn the practices well, then once a week for the remainder of the period. Sixty-minute sessions included a brief time at the beginning of class to socialize with other participants and 45-50 minutes of practice. Participants were asked to practice at home at least 30 minutes a day, 5 days per week (preferably more as time and level of energy permitted), or in pairs/groups with other classmates. Instructors provided guidance for adaptations or reductions in the protocol for individuals as necessary (e.g., doing exercises in a sitting position or doing fewer repetitions in the beginning) for class practice as well as home practice.

B.5. Adherence Strategies

Elements of Social Cognitive Theory were integrated into adherence strategies implemented to encourage home practice and class attendance [9]. Instructors provided encouragement and positive feedback during sessions; a one-page newsletter provided updates on individual and group progress such as examples of patient milestones reached, reports of perceived benefit, and human interest success stories (behavioral capability and self-efficacy; role modeling/rewards); and a “buddy” system designed to promote class attendance and social interaction, encourage home-based programs, and share transportation (social support). A weekly phone call (5-15 minutes) from a blinded non-interventionist study staff member was made to all participants to remind about class attendance, inquire about home practice adherence, and encourage reflection on self-expectations and goal-setting.

  1. Process control and intervention fidelity

C.1. Dose and frequency

Data for the dose and frequency of the exercise protocol were gathered via participant logbooks to assure equivalence across arms of study. Participants were given logbooks after the first class and asked to record minutes of practice each day and weekly assessments of level of exertion during practice. Attendance sheets recorded participant class attendance. Total minutes of practice were calculated by combining minutes noted in the logbooks for home practice and minutes in class, using attendance records and counting 50 minutes of practice per class. The Borg Rating of Perceived Exertion (RPE) is the preferred method to assess exercise or activity intensity among those individuals who take medications that affect heart rate or pulse [10]. Intervention fidelity was assessed using the Meditative Movement Inventory [11], measuring key components of meditative movement, that is, the degree of perceived Meditative Connection, and Breath Focus, assuring that the QG/TCE was practiced as taught, and that the SQG de-emphasized these components. Participants were asked about any additional symptoms or adverse events during class time and in the weekly phone calls. No adverse events were reported.

C.2. Study blinding

Both interventions were called “Rejuvenating Movement” with the intention of blinding participants to the preferred arm of the study. Unblinded staff included the project coordinator (who took random assignment ID lists generated by the statistician from consented participants and contacted individuals to schedule them into classes), and the instructors who knew the goals of the study. Other staff remained blinded to study assignment.

  1. 3. Study control variablesand Complementary and Alternative Medicine (CAM) attitude checks

Patients were asked at the end of the study if they thought they were in a class that was “Like Qigong” and “Like Tai Chi” and they were asked to rate their attitude about the benefit and worthwhileness of the Rejuvenating Movement intervention. Patient’s attitude toward CAM in general was also queried to examine predisposition toward CAM, positive or negative attitude, as a mediating response to the intervention.Statistical analysis of the post-intervention equivalence and fidelity checks was performed using two-sample independent t tests and Fisher’s Exact tests. Results of these tests are presented in Table A. Participant perceptions and expectations of the interventions, and the dose (minutes practiced and intensity of exercise) were equivalent for both study arms.Meditative Movement Inventory ratings of the interventions indicated that Meditative Connection was significantly stronger for QG/TCE than SQG; Breath Focus did not reach significance. There is a concern that the contrast between the two interventions may have not been enough. Although the “meditative connection” component of the QG/TCE was significantly stronger than for SQG, the “breath focus” did not quite reach significance. Even though these components were not taught as part of the SQG, there were women in some of the SQG classes who commented on the absence of this instruction, (e.g., “So, aren’t we supposed to be taking deep breaths as we practice?”), perhaps due to prior experience with traditional exercise, and triggering a focus on the breath among participants.

Table A: Tests of Equivalence and Fidelity

SQG
Mean (SD) / QG/TCE
Mean (SD) / t a(df) / b (2-tailed p)
Equivalence Tests
RM Attitude / 3.49 (1.14) / 3.95 (1.34) / - 1.66 (76) / 0.101
Like QG/TC / 5.18 (2.45) / 5.19 (2.91) / - .18 (17) / 0.996
CAM Attitude / 3.76 (.83) / 3.89 (1.04) / - .48 (63) / 0.632
Borg RPE Score / 9.85 (2.20) / 9.79 (2.98) / .06 (42) / 0.774
Total Min Practiced / 1194 (617) / 1290 (1106) / .51 (85) / 0.613
MMI (Fidelity Test)
Breath Focus / 2.45 (.831) / 2.16 (.714) / 0.090
Meditative Connection / 3.90 (1.20) / 2.73 (1.11) / 0.001

adf shows varying participation/missing data for these measures

bp-values from two sample independent t test

Expected to be equivalent for blinding:

RM Attitude = Rejuvenating Movement Attitude Scale, 1-9 (1 = high; 9 = low benefit)

Like QG/TC = Like Qigong/Tai Chi, 1-9 (1 = less, 9 more like QG/TC)

CAM Attitude = Complementary/Alternative Medicine Attitude (1-5 low to high value)

Expected to be different to establish fidelity of Meditative Movement aspects of QG/TCE intervention vs. sham control using Meditative Movement Inventory (MMI):

Breath Focus, 1-6 (1 = high breath focus, 6= low breath focus)

Meditative Connection, 1-6 (1 = high meditative connection; 6 = low meditative connection)

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