Caring for Caregivers With Mind-body Exercise
Phase: NA
Conditions: Caregiver Distress, Physical Function, Quality of Life
Sponsor: University of Houston

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PRINCIPAL INVESTIGATOR:
Pinky Shani, PhD, RN 
University of Houston 
College of Nursing 
(713) 743-7181
pshani@central.uh.edu
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Table of Contents
1.0
OBJECTIVES
4
2.0
BACKGROUND
4
3.0
INCLUSION AND EXCLUSION CRITERIA
6
4.0
VULNERABLE POPULATIONS
6
5.0
NUMBER OF SUBJECTS
6
6.0
RECRUITMENT METHODS
7
7.0
STUDY TIMELINES
8
8.0
STUDY ENDPOINTS
8
9.0
PROCEDURES INVOLVED
8
10.0
SETTING
12
11.0
RISKS TO SUBJECTS
12
12.0
POTENTIAL BENEFITS TO SUBJECTS
13
13.0
WITHDRAWAL OF SUBJECTS
13
14.0
COSTS/PAYMENTS TO SUBJECTS
13
15.0
CONFIDENTIALITY
13
16.0
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS
14
17.0
INFORMED CONSENT PROCESS
14
18.0
PROCESS TO DOCUMENT CONSENT IN WRITING
15
19.0
DATA MANAGEMENT
15
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20.0
SHARING OF RESULTS WITH SUBJECTS
17
21.0
RESOURCES
17
22.0 ADDITIONAL APPROVALS
18
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1.0
Objectives
1.1 Using cancer caregivers (CCGs) as a representative population of the larger CG 
population, our long-term goal is to conduct a large-scale fully powered trial 
evaluating a widely accessible and previously studied Qigong regimen (Eight 
Brocades, Baduanjin Qigong). The goal of this R34 is to conduct a mixed-methods 
pilot randomized controlled trial (RCT) to inform the feasibility and design of a 
future larger definitive trial.
Primary Objectives:
1.
To finalize intervention content and delivery of both in-person 
community-based group and individual internet-based Qigong protocols.
2.
To assess the 'learnability' of Qigong delivered in community-based group 
classes and via an internet-based protocol using a novel proficiency 
instrument.
3.
To evaluate the feasibility of recruiting and retaining cancer caregivers 
into a 12-week clinical trial, and completing all outcomes testing 
protocols.
1.2 We hypothesize that participant recruitment, retention, and adherence to intervention 
and assessment protocols will comply with target goals. Feasibility will be assessed 
with respect to participant recruitment, retention, intervention adherence, and 
intervention acceptability. We will assess recruitment feasibility by the number of 
screened and eligible participants and the number refusing to participate. We will 
document reasons for refusal. This domain of feasibility will require: a) ≥ 50% 
screened individuals are study eligible and b) ≥ 5-10% of eligible participants are 
willing to consent. With a goal of n = 54 enrolled over a one-year period, we will 
need to screen 14 participants per month. Participant retention will be deemed 
feasible if loss to follow-up is ≤ 20%. Intervention adherence will require: a) ≥ 70% 
participation in community or internet-guided classes and > 50% compliance with 
home practice guidelines. Qualitative interviews with CCGs, including those who 
drop out and have low adherence, will be used to further inform overall study 
feasibility, and facilitators and barriers to participation.
2.0
Background
2.1 Longer life expectancies and an aging population mean that an increasing number of 
adults are likely to develop multiple comorbidities and rely on informal CGs for 
support.1 Informal CGs, typically family members or friends, are responsible for 
caring for individuals with a variety of burdensome conditions including advanced 
age, dementia, and cancer. The average number of hours spent caregiving is often 
greater than 21 per week.2 In addition to providing psychological support, CGs are 
also commonly responsible for relatively complex medical procedures, despite 
limited or no formal training, as well as taxing physical support (e.g., weight 
transfers, increased household chores). Collectively, these responsibilities result in 
substantial and chronic stress, with negative psychological and physiological effects 
on CGs’ health.3-5 Informal CCGs provide 70 to 80% of care for those with cancer
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and are involved during the cancer care trajectory from diagnosis to death.6, 7 The 
burden of caring for someone with cancer can be extremely high; 50% of CCGs 
report increased levels of stress and depression with 40% indicating that they need 
help managing their own emotional and physical stress.2 CG burden has even been 
identified as an independent predictor of caregiver mortality with a 63% increased 
risk of death.8 Additionally, research indicates that decreased CG QOL directly 
impacts the QOL of care recipients.9 10 Moreover, the burden among CCGs often 
persists for years after patients’ initial cancer diagnosis, with evidence of long-term 
detriments to health and QOL.11-14  Therefore, there is a pressing need to develop 
effective and practical interventions to prevent and manage the psychological and 
physical stressors that reduce QOL in CGs.
2.2 Not applicable.
2.3 Mind-body practices that target both psychological and physical dimensions of 
distress offer a promising and pragmatic therapeutic strategy for addressing the needs 
of CGs. 15-17 However, the evidence required to guide such an approach is still limited 
in multiple ways. First, while a growing body of research supports mind-body 
practices such as Tai Chi, Qigong, yoga and meditation for a range of symptoms in 
patients with chronic disease,18-22 few large scale studies have evaluated impact of 
these practices in CGs. Of the studies which have evaluated CGs (mostly yoga or 
MBSR), many have utilized interventions tailored to patient-CG dyads.21, 23-26 
Although this approach has merit, it may limit targeting CGs psychological and 
physical needs. Additionally, while many MBSR and yoga studies show positive 
effects on mental health, most do not include physical function and disability 
measures. Lastly, more widespread access to mind-body interventions targeting CGs 
has been challenged by economic, geographic, and time barriers.27 Common barriers 
to in-person group classes (e.g., issues with CG travel to community-based programs) 
might be overcome with internet-based delivery of intervention, offering an alternative 
for some CGs that may significantly increase access and adherence. While internet 
delivery of individual-based mind-body practices is increasingly studied and        
shows promise,1 this approach has not been explored in CG populations.
Qigong is an increasingly popular multi-modal mind-body exercise that shows 
promise in addressing a broad range of psychosocial and physical factors highly 
relevant to CGs. Sharing many characteristics with Tai Chi, Qigong incorporates 
elements of slow gentle movement, breath training, and a number of cognitive skills 
including heightened body awareness, focused mental attention, and imagery—which 
collectively may afford greater benefits to health compared to unimodal therapies.28-30 
In contrast with typical Tai Chi choreography, some Qigong regimens focus on 
simpler repetitive movement phrases, which make them easier to learn both through 
in-person instruction and especially via video-guided instruction. A robust evidence 
base supports that across adult populations, Qigong and Tai Chi training in groups  
can improve multiple domains of physical and emotional health, including those 
highly relevant to CGs such as depression,31-33 anxiety,31, 33 poor sleep,33-36 
musculoskeletal strength,34, 36 balance during functional activities,34, 36  pain,31, 37-40
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and core underlying physiological processes such as inflammation.41, 42 Reduction of 
overall distress and improved long-term prognosis is also supported by improvements 
in broader constructs including overall QOL31, 33 and self-efficacy.15, 34, 43 While 
Qigong is increasingly being used to help manage health and distress in CGs, 
(including at leading academic medical centers like MD Anderson Cancer Center and 
Harvard's Dana-Farber Cancer Institute), we are not aware of any studies to date 
evaluating Qigong for CGs.
3.0
Inclusion and Exclusion Criteria
3.1 Inclusion criteria include (1) age ≥35 years; (2) a spouse, partner, family member, or 
friend providing physical, emotional, and/or financial support for a cancer patient; (3) 
able to understand, speak, and read English; (4) minimum level of 3 on the National 
Comprehensive Cancer Network’s (NCCN) Distress Thermometer adapted for CGs; 
and (5) able to provide informed consent. Exclusion criteria include (1) unstable  
illness (e.g., recent hospitalization, unstable cardiovascular disease, active cancer); (2) 
psychiatric disorders (e.g., unmanaged depression or psychosis, substance abuse, 
severe personality disorder); (3) degenerative neuromuscular condition (e.g., 
Parkinson’s disease, multiple sclerosis); (4) inability to walk continuously for 15 
minutes; (5) recent history of attending regular Qigong or similar (e.g., yoga or Tai 
Chi) classes defined as 20 or more classes in the past 6 months; or 6) participation in 
more than 240 minutes of moderate-intensity exercise per week (as these individuals 
already exhibit high exercise self-efficacy and are less likely to be otherwise 
symptomatic).
3.2 Potential subjects will be screened for eligibility based on these criteria over the 
phone. This call will be based on a script that comprehensively addresses all inclusion 
and exclusion criteria to ensure that each potential participant is appropriately 
screened.
3.3 This study will not include adults unable to consent, individuals who are not yet 
adults (infants, children, teenagers), pregnant women, prisoners, students for whom 
the researchers have direct access to/influence over grades, or economically and/or 
educationally disadvantaged persons.
4.0
Vulnerable Populations
4.1 Not applicable.
5.0
Number of Subjects
LOCAL:
5.1 We expect to consent, enroll, and randomize a total of 54 CCGs.
5.2 The sample size was based on practical/budgetary constraints as well as a preliminary 
power analysis. A power analysis was conducted to determine the minimum sample
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size that is required to find significance with a power set of .80, an alpha level at
.05, correlation among the repeated measures of 0.3, and a moderate effect size of .25 
using G*Power version 3.1. Based on the primary analysis, to ensure sufficient power 
on the repeated measure ANOVA (3 time points x 3 groups), a total of 48 participants 
are required. In consideration of 10-15% of attrition rate, a total of 54 participants  
will be recruited.
6.0
Recruitment Methods
LOCAL:
6.4 Interested individuals identified through recruitment strategies will be provided 
contact information to call the study coordinator for an initial phone screen. The 
coordinator will use a phone screen script to review details of the study with potential 
participants. To conduct the initial screen, the coordinator asks participants a series of 
questions related to study inclusion criteria. If the participant meets the inclusion 
criteria the coordinator will continue the screen with questions about exclusion criteria. 
If the individual is eligible and interested, they will then be scheduled for an in-person 
visit to University of Houston, College of Nursing, to complete their                 
baseline visit and receive their group assignment. At this visit, eligibility will again  
be confirmed by asking the same series of questions about inclusion and exclusion 
criteria to confirm their eligibility status. After we confirm eligibility, consent is 
obtained, and baseline assessments made. We will document reasons for refusal.
6.5 Multiple recruitment sites and methods will be used for recruitment. Our primary 
recruitment site will be MD Anderson Cancer Center (MDACC) facilitated by Dr. 
Lorenzo Cohen (study consultant). The distribution of how subjects were contacted 
and participation rate will be systematically tracked using screening logs. Recruitment 
feasibility will be assessed by the number of screened and eligible                
participants and the number of CCGs refusing to participate. Participants may also be 
sourced from churches, other support groups, social media postings, or by word-of- 
mouth. Recruitment strategies include presenting the study at monthly staff meetings in 
various cancer subspecialties, providing study brochures to oncologists, nurses, and 
administrative staff to be passed on to patients and their families, presenting at CG 
support group events, and posting the study on relevant hospital web sites including 
those specific to recruiting volunteers into clinical trials. In addition, participants will 
be recruited through non-hospital online websites such as the Houston Chapter of the 
Oncology Nursing Society and the Family Caregiver Support Network. Other 
strategies include targeted advertising in local newspapers and posting of flyers in 
public places (e.g., library, senior centers).
6.6 Potential subjects may be identified by their attendance at support groups for cancer 
caregivers. They may also be identified at any of the functions listed above if they 
mention to a member of the research team that they are currently a caregiver for a 
cancer patient. Study consultants will also work to identify potential participants and 
provide them with information about the study if they are interested. Potential
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subjects may also be identified if they contact a member of the research team after 
encountering the study flyer or speaking with a past study participant.
6.7 The materials used for recruitment include a study flier and PowerPoint presentations 
(when information about the study is presented to a group).
7.0
Study Timelines
7.1 For Cohorts 1 and 2, we will randomize (1:1:1) 24 CCGs to one of three 
conditions: (1) A community- based Qigong program; (2) an internet-based 
Qigong program; or (3) a self-care control group. For Cohort 3, we will randomize 
(2:1) 15 CCGs to one of two conditions: (1) an internet-based Qigong Program, or (2) a 
self-care control group. For Cohort 4, we will randomize (2:1) 15 CCGs to one of two 
conditions: (1) a community-based Qigong program, or (2) a self-care control group. 
Our primary outcomes are feasibility and acceptability. 
7.2 Participants in the community-based programs will attend one, 75 minutes class per 
week supplemented by home practice (guided by printed materials) for 20 minutes on 
3 additional days. Participants in the internet-guided program will be asked to follow 
two online sessions for 40 minutes each, also supplemented by home practice for 20 
minutes on 3 additional days. Participants in both Qigong groups will commence 
training within 2 weeks of baseline visits. Caregivers randomized to either Qigong 
intervention can expect a total time commitment of 30 hours to complete all study 
related activities.
Individuals randomized to the self-care control group will be provided with an 
educational book on caregiving, they will also be provided with a “Self-Care Manual” 
that includes self-guided activities related to caregiving and caregiver health.
Caregivers randomized to this group can expect about a 5-hour total time 
commitment to study related activities.
7.3 Baseline and 12-week assessments including psychosocial measures and QOL, 
physical function and cognitive measures will occur in person for all participants at 
the University of Houston College of Nursing in Sugarland, Brazos Hall, Room 
103A. In addition, a short qualitative interview will be conducted with participants in 
the community-based and internet-based classes. A longer-term 6-month follow-up 
will assess psychosocial and QOL measures using a mail-in questionnaire packet. 
Primary analyses should be complete by 08/31/2021.
8.0
Study Endpoints
8.1 This is a minimal risk study. There are no safety endpoints given there are no safety 
risks associated with the study.
9.1
Procedures Involved
9.1 Using CCGs as a representative population of the larger CG population, our long- 
term goal is to conduct a large-scale fully powered trial evaluating a widely 
accessible and previously studied Qigong regimen (Eight Brocades, Baduanjin 
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Qigong). Interventions will be delivered either in community-based groups led by 
instructors or via internet to individuals learning thru recorded guided instruction
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supplemented with intermittent virtual live feedback from instructors. Outcomes will 
include QOL, fatigue, sleep disturbances, psychological distress, CG burden, and 
physical function. The short-term goals of this R34 are to conduct a mixed-methods 
pilot randomized controlled trial (RCT) to inform the feasibility and design of a 
definitive trial. We will address these goals by randomizing 54 CCGs to one of three 
conditions: (1) A community-based Qigong program; (2) an internet-based Qigong 
program; or (3) a self-care control group.
9.2 At the baseline visit, eligibility will be confirmed, consent will be obtained, and the 
consent process will be documented. Written informed consent will be obtained by   
the research assistant or study staff. The subject will be asked to review the study 
consent form. Investigator or research staff will meet with the subject to review the 
form, to confirm the subject’s understanding of the study, and to answer any   
questions that the subject might have. Once the subject demonstrates understanding of 
the study and agrees to participate in the study, the consent will be signed in the 
presence of the investigator or research staff. Informed consent will be obtained and 
reviewed by the University of Houston Institutional Review Board as appropriate. For 
the duration of the Covid-19 Pandemic, all participants and research staff will follow 
the University of Houston Department of Research’s Covid-19 precautions. These 
precautions will be followed during any in-person assessment or in-person Qigong 
class. All participants and research staff will have a contactless temperature screening 
prior to any in-person activity. Masks will be worn and social distancing maintained 
during all in-person assessments and in-person Qigong classes.
At the initial visit at University of Houston, College of Nursing, participants will 
complete informed consent. This date will be recorded on a case report form as the 
date of enrollment into the study.
In addition, at this visit initial assessment related to QOL, psychological well-being, 
caregiver burden, cognitive and physical function will be measured. All outcomes   
will be assessed at baseline and 12 weeks, following completion of the 12-week 
intervention. All in-person assessments will be conducted by trained research 
assistants. Baseline and follow-up assessments are estimated to require 2.0 hours.
At the baseline and 12-week appointments, consented participants will be videotaped 
performing the Eight Brocades. This video will help assess learnability of the 
intervention and help with the development of the scoring instrument.
Semi-structured, open-ended interviews lasting approximately 30 minutes will be 
conducted at the 12-week assessment for participants in all groups. Questions will 
focus on characterizing participants’ perceived effectiveness and enjoyability of the 
Qigong intervention, both community-based and internet-based, and identifying 
facilitators and barriers to participation. Questions specific to the mode of 
intervention delivery may include those related to use of technology, the role of face- 
to-face instructor feedback, perceived motivators to adherence, and self-efficacy.
In weeks 1, 2, 4 and 6 of the program, participants will participate in a one-to-one call 
with a Qigong instructor. This call will be audio recorded and will give participants  
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the opportunity to address any training- related questions or concerns, and to receive 
personalized feedback and encouragement from the instructor. At the 12-week 
assessment, participants will be asked to return the computer tablet. Participants will
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be asked to keep track of their home Qigong practice on provided logs throughout the 
study. We will ask participants to send their logs to the study researchers at the end of 
each week, and we will provide them with stamped envelopes for mailing.
9.3 The Qigong Instrument used is the Eight Brocade Protocol. Qigong is an increasingly 
popular multi-modal mind-body exercise that shows promise in addressing a broad 
range of psychosocial and physical factors highly relevant to CGs. Sharing many 
characteristics with Tai Chi, Qigong incorporates elements of slow gentle movement, 
breath training, and a number of cognitive skills including heightened body 
awareness, focused mental attention, and imagery—which collectively may afford 
greater benefits to health compared to unimodal therapies.28-30
Table 1. Template for Group-Taught Eight Brocade Protocol
Approx. Duration
Week
Activities
(in minutes)
1-2
Check-in
2
Qigong Warm-up Exercises
Qigong Swinging and Drumming the Body 
Swinging Up and Down
Spiraling the Waist 
Mindful stretching
Lower Extremities (feet, ankles, knees)
20
Upper Extremities (hands, arms, shoulders) 
Spinal Cord Breathing
Washing with Qi from the Heaven 
Tan Tien Breathing
Introduction to Eight Brocades Movements #1-4
35
#1 Holding the Hands High to Regulate Internal Organs
#2 Posing as an Archer Shooting Both Left- and Right-Handed
#3 Holding One Arm Aloft to Regulate Spleen and Stomach
#4 Looking Backwards to Prevent Sickness and Strain
Cool-Down Exercises
3
Self-massage and meridian tapping
3–8
Check-in
2
Qigong Warm-up Exercises
10
Review/ Practice Eight Brocades Movements #1-4
15
Learn and practice Eight Brocades Movements #5-8
30
#1 Swinging the Head and Lowering the Body to Relieve Stress
#2 Moving Hands Down Back and Legs, and Touching Feet 
to Strengthen Kidneys
#3 Thrusting Fists and Making Eyes Glare to Enhance Strength
#4 Raising and Lowering the Heels to Cure Diseases
Cool-Down Exercises
3
9–12
Check-in
2
Qigong Warm-up Exercises
10
Review/ Practice/ Refine Eight Brocades Movements #1-8
45
Cool-Down Exercises
3
9.4 In addition to caregiver distress, medical history and demographics, the following 
outcomes will be assessed at baseline, 12-weeks, and 6-months:
The following will be measured at baseline and 12-weeks:
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
Grip strength of the dominant hand will be measured using a Jamar hydraulic hand 
dynamometer (Patterson Medical – Canada, Mississauga, ON, CAN).44

Timed Up-and-Go Single and Dual Task will be completed among participants. For 
the single task, CGs will be asked to sit in a chair with their back against the back of 
the chair. When the researcher says, “Go,” the participant will walk briskly around a 
marker on the floor and back to the chair. The stopwatch is stopped when the 
participant’s backside and back are against the chair. For the dual task, the participant 
completes the steps above in addition to counting backwards by 3s from 100. Both 
tests will involve two trials.

Digit Span45 measures verbal short-term memory. Participants will be asked to repeat 
numbers in a specific order. Performance is indicated by the average number of digits 
correctly remembered.

Trail Making Test Parts A & B46 consist of 25 circles distributed over a sheet of paper. 
Participants are timed as they connect the circles without lifting the pen or pencil from 
the paper.
The following is a table of study measures:
Measure
QOL
Description

Promis-29. 29 items consisting of self-reported health
measures in the domains of physical health, mental 
health and social health.
Depression

Patient Health Questionnaire-9 (PHQ-9). 9 items
measuring depression and used to grade severity of 
symptoms.
Anxiety

Generalized Anxiety Disorder (GAD-7). 7 item tool used
for screening, diagnosis and severity assessment of 
anxiety disorder.
Fatigue

Brief Fatigue Inventory (BFI): 9 items measuring the
severity of fatigue and the impact of fatigue on daily 
functioning in the past 24 hours.
Perceived Social Support

Multidimensional Scale of Perceived Social Support
(MSPSS). 12 item scale designed to measure perceived 
social support from three sources; Family, Friends and a 
Significant Other.
Sleep Disturbances

Pittsburgh Sleep Quality Index (PSQI): 19 items
measuring patients’ sleep quality, sleep latency, sleep 
duration, habitual sleep efficiency, sleep disturbances, 
sleeping medication use, and daytime dysfunction over 
the past month.
Perceived Stress

Perceived Stress Scale (PSS). 10 item psychological
instrument measuring the perception of stress.
Caregiver Burden

Caregiver Burden Scale (CBS): 14 items measuring the
impact of caregiving on three dimensions of burden: 
objective, subjective demand, and subjective stress.
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Exercise self-efficacy

Self-Efficacy Scale: 13 items measuring self-efficacy
expectations related to the ability to continue exercising 
in the face of barriers to exercise.
Physical Activity

Godin Leisure-Time Exercise Questionnaire: 4 items
measuring the frequency of light-intensity, moderate- 
intensity, and vigorous-intensity leisure-time physical 
activity.
10.0
Setting
10.1 The baseline assessment and 12-week follow-up assessment components of the 
research will take place at the University of Houston College of Nursing Campus at 
14000 University Blvd., Sugar Land, TX, Brazos Hall Room 103A. The Community- 
based Intervention group Qigong classes will take place at 3500 Audubon Place, 
Houston, Texas 77006. Classes will be held every Wednesday at 2pm.
11.0
Risks to Subjects
11.1 There is a potential for minor musculoskeletal aches and pain that might result due 
to the Qigong exercises in both the community-based and internet-based programs. 
These are typical in any low intensity physical activity program. Participants will be 
instructed and regularly reminded to adjust the level of activity based on their 
individual abilities. Nonetheless, our instructors are BLS-trained, and Dr. Shani will 
be available by phone in the event of an adverse event. All participants who 
participate in the study will have the opportunity to withdraw at any time. There are 
no other known or anticipated risks of physical, mental or social injury to those who 
will participate in the study.
11.2 When starting an exercise program, individuals may experience temporary muscle 
soreness or stiffness. Increased physical activity may worsen an underlying pain 
condition. These unlikely but possible conditions will be monitored closely at each 
testing visit. If, at any point, an issue is detected, participants will be immediately 
referred back to their primary provider for routine care.
11.3 We will utilize a multi-pronged approach to monitor safety and track Adverse   
Events (AEs) throughout the study with formal oversight by a University of Houston, 
Institutional Review Board. For participants attending community classes, instructors 
will be trained to track and report any observed or participant-reported AE in an AE 
log provided by the study. Participants assigned to both community- and internet- 
based training will also be asked to complete an AE survey as part of the home 
practice log, which are sent to study staff weekly. Participants in the self-care control 
group will be called monthly to ask about any adverse events, and more generally, to 
maintain contact with study staff. Finally, all participants will be queried in person at 
12 weeks about AEs experienced over the course of the study. When an adverse event 
is reported through any of the above tracking mechanisms, the study PI will be
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notified. Any adverse events experienced are followed by the PI and reported to the 
University of Houston IRB according to established guidelines. If the participants have 
any questions about their rights as a subject or how this research study is being 
conducted, they are told in the written consent form to contact Dr. Shani.
12.0
Potential Benefits to Subjects
12.1 CGs represent a well-defined, large and growing subset of a larger population of 
CGs that overlap greatly in the constellations of morbidities that lead to high levels of 
distress. The multi-modal nature of the Eight Brocades Qigong regimen explicitly 
targets both psychosocial and physical functional symptoms, thus expanding the scope 
of mind-body studies for CGs to date, which have largely focused on stress 
management and psychological wellbeing.
12.2 Our pilot study, and our eventual large-scale comparative effectiveness trial, explores 
the effectiveness of Qigong training delivered in both community-based              
group classes and through self-guided internet-based modules supplemented with one-
on-one virtual learning support. This design is innovative for multiple reasons. A
finding that both methods are effective would lead to multiple options for CGs. Those 
with flexible schedules and seeking group support and the opportunity for a change of 
environments might choose community classes. Those with unpredictable and 
inflexible schedules and an inability to leave the home could develop a self-guided 
training plan, with one-on-one virtual support scheduled at a convenient time. More 
generally, the evidence-base for DVD- and internet-based learning of mind-body 
exercise is essentially non-existent. Studies are desperately needed to evaluate whether 
the promising evidence of Qigong's effectiveness based on group and instructor      
lead clinical trials is also observed when instructions are delivered virtually.
12.3 Since risks of the study are minimal, and the benefits are potentially large, the risk- 
benefit ratio is strongly on the side of benefit.
13.0
Withdrawal of Subjects
13.1 All participants who participate in the study will have the opportunity to withdraw at 
any time.
14.0
Costs/Payments to Subjects
14.1 The study intervention and all related items (parking costs, iPads, tablets, 
caregiver helpbook, etc.) will be provided at no cost to participants. 
Participants will be compensated for participating in the study with $125 in 
Amazon gift cards. A $50 gift card will be provided after the baseline 
assessment, another $50 gift card will be provided after the 12-week follow up 
assessment, and a final $25 gift card will be provided after the completion of 
the 6-month follow-up survey.
15.0
Confidentiality
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15.1 Participant confidentiality will be maintained at all times. Each participant will be 
given a unique study ID that does not contain personal identifying information and will 
be used for all research purposes. Names, code numbers and telephone numbers      
will be kept in locked secure files, separate from the study data. Likewise all physical 
study data will be kept in locked storage and all electronic study data will be   
password protected with access restricted to approved personnel. Any document 
linking the participant name to an identification number will be kept in a locked file 
separate from data collection files. Study reports will be aggregated so that individual 
participants are not identified. All data will be stored in databases, identified only by 
study ID number, behind appropriate firewalls and with institutional backup.
15.2 Only the Principal Investigators and grant coordinator will have access to the names 
associated with the identifiers, which will be kept locked in separate files.
15.3 Hard copies of identifiable data will be shredded within 5 years from the completion 
of the study date (08/31/2026) or by the time all data has been published in manuscript 
format, whichever comes first.
15.4 Electronic identifiable data will be physically destroyed by the services provided by 
the Iron Mountain Information Management which is AAA certified by the National 
Association for Information Destruction.
15.5 Recordings will be destroyed after transcription of audiotapes.
16.0
Provisions to Protect the Privacy Interests of Subjects
16.1 Participants will be assured that personal identifiers will be detached from all 
data and a random study ID number will be used. Only the PI and research 
assistant will have access to the study ID code. In-person assessments will be 
held in a private room. Phone calls concerning the study will be prefaced by 
the research team asking if the participant is comfortable discussing their study 
activities at that time, and if they are not, an alternate phone call time will      
be established. 
16.2 At any point that a participant feels uncomfortable with questions or study 
procedures, we will remind the participant that it is a voluntary study and they 
do not have to proceed.
17.0
Informed Consent Process
17.1 Informed consent will be obtained from all participants. The consent process 
will take place upon the participant’s arrival for the baseline assessment, prior 
to any study procedures. The consent form will describe the purpose of the
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study, the procedures to be followed, and the risks and benefits of participation. 
Each page of the consent form will be reviewed with the participant prior to 
their signing. Approximately 20-30 minutes will be devoted to discussing the 
consent form, and the participant will have unlimited time to ask any questions. 
After the consent form has been discussed, a signed copy of the consent form 
will be obtained from each participant. A copy will also be given to each 
participant and this fact will be documented in the participant’s record. This 
research will be following “SOP: Informed Consent Process for Research 
(HRP-090).” Participants who are unable to provide informed consent are 
ineligible from study participation.
Interested participants will be pre-screened for eligibility over the phone. A 
waiver of written documentation of consent for prescreening has been 
requested.
a. The written script of the information to be provided orally can be found 
within the Phone Screen Template (attached). The written script of the 
information to be provided and all written information to be provided include 
all required and appropriate additional elements of consent disclosure.
b. The research presents no more than Minimal Risk of harm to subjects.

Qigong is considered a low, impact mind-body exercise program. 
Stretching will be completed prior to the initiation of our program. 
Participants will be encouraged to practice at their own pace, and  
take rests according to their needs. In addition, subjects will be 
regularly monitored for adverse effects of exercise during visits. 
Subjects in the community-based and internet-based programs will be 
instructed to notify their healthcare provider first, and then study staff 
of any changes in health status. The PI will contact participants by 
telephone if any reported adverse event suggests clinical deterioration 
warranting immediate medical attention. During the study, if a subject 
experiences a medical problem as deemed by the study physician or 
subject’s regular care provider that prevents participation in the 
Qigong program, he/she will be temporarily suspended from the study 
and will resume when at baseline clinical status.
c. The research involves no procedures for which written consent is normally 
required outside of the research context.

The research does not involve any procedure for which additional consent is 
required. All components of the research have been addressed within the 
consent.
d. Written information describing the research is to be provided to the subject, 
or the subject’s legally authorized, representative.

This includes the detailed consent form, flyer, and a specific letter 
addressed to participants based on their randomization to either the 
community-based, internet-based, or self-care group.
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17.2 Non-English Speaking Subjects
Not applicable.
18.0
Process to Document Consent in Writing
18.1 This study will be following “SOP: Written Documentation of Consent 
(HRP-091).”
19.0
Data Management
19.1 Data will be managed using the REDCap data management system supported 
through UH. REDCap is a secure, web-based application for managing online 
databases. REDCap provides automated export procedures for seamless data 
downloads to Excel and common statistical packages such as SAS. Case report forms 
will be produced using built-in features of REDCap.
Feasibility. We will use descriptive statistics to evaluate recruitment and retention 
rates, attendance at classes, and adherence with online intervention. Retention rate  
will be reported by group at the end of the study. Attendance will be recorded as the 
proportion of classes attended for community-based classes; and online video tutorial 
use, logs of home practice, numbers of logins to the webpage, clicks on education 
links, downloads and views of videos for the internet-based classes. We will consider 
study retention successful if the retention rate is at least 80% at 12 weeks, and 
attendance at in-person classes and home compliance to internet-based lessons is at 
least 70%. Similar criteria will be set for internet-based compliance as well as home 
practice compliance in both groups. We will test for non-inferiority of the observed 
rates relative to the expected rates of retention and attendance assuming that the 
retention and attendance rates follow a beta-binomial distribution. Non-inferiority 
margins will be determined as 90% lower confidence bounds on the estimated rate for 
participants in each group. Maximum likelihood will be used to obtain significance 
and confidence intervals. Relative risk of non-completion between each Qigong 
training method and self-care control group will be used to represent study completion 
rates with inference based on separate Fisher’s exact tests.
Estimating variance for future power calculations. We will use linear mixed 
models with fixed effects of visit and treatment x post-baseline visit interaction and 
unstructured covariance among repeated measures to analyze efficacy outcomes. This 
will yield six variance components required for future power calculations. The Wald 
statistic from the treatment x visit interaction testing 12-week treatment-dependent 
response will be used to estimate the effect of Qigong and as a criterion for selecting 
outcomes that are potentially sensitive to Qigong. Selection of the outcomes to include 
in our future trial, and which to select as the primary outcome, will also be
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guided by consideration of clinical relevance, participant burden, and cost. The study 
will have 80% power to identify the outcome that is truly most responsive to Qigong 
from among the 14 measures calculated from the 12 assessments completed at 12 
weeks if the most responsive measure is associated with an effect size at least 0.43 
SD greater than the others.
Inter-rater reliability and validity testing of proficiency instrument. Inter-rater 
reliability will be evaluated using Cohen's Kappa statistic. Validity testing based on 
cross-sectional comparisons of proficiency scores and practitioner's years of training 
will utilize Pearson's correlations. Associations between longitudinal changes in 
proficiency and clinical outcomes will be evaluated using mixed model approaches 
described above.
Qualitative analysis. Semi-structured qualitative interviews will be audio recorded 
and transcribed verbatim. Thematic analysis will be informed by grounded theory 
methods to guide description of qualitative interviews. Questions will focus on 
facilitators/barriers to recruitment/participation, and acceptability of the intervention 
and its specific components. Two investigators will independently code transcripts to 
identify emergent themes in an iterative process until thematic saturation is reached as 
in prior studies.47, 48 49-51 Transcription, coding, and analysis will be conducted in 
NVivo v11.
19.2 Three documents will have identifiable data: Informed Consent (name), 
Screening Questionnaire (name, age, ethnicity, phone number, and email 
address), and Screening Log (name, phone number). At the baseline 
assessment, each participant will be given a unique study ID that does not 
contain personal identifying information and will be used for all research 
purposes. All physical study data will remain locked at all times in a file 
cabinet in the PI’s office, and all electronic study data will be password 
protected with access restricted to approved personnel. Study reports will be 
aggregated so that individual participants are not identified. All data will be 
stored in databases, identified only by study ID number, behind appropriate 
firewalls and with institutional backup.
19.3 All data sets will be verified for accuracy by the PI, Co-PI, and grant coordinator. 
Research data and subject files will be audited for accuracy during the initial months 
of testing/interviewing and subsequently every 6 months. All REDCap data and 
subject files will be double cross-checked after they have been entered and/or stored.
19.4 Identifiable data will be stored in a locked file cabinet in Dr. Shani’s office. 
Names, code numbers and telephone numbers will be kept in locked secure 
files, separate from the study data. Any document linking the participant 
name to an identification number will be kept in a locked file separate from 
data collection files.
19.5 Data will be stored for up to 5 years from the completion of the study date 
(08/31/2026) or by the time all data has been published in manuscript format, 
whichever comes first.
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19.6 Only the research team will have access to the data.
19.7 The research team will be responsible for the receipt of data.
19.8 Not applicable.
20.0
Sharing of Results with Subjects
20.1 Study results will be shared with participants via email or physical mailing 
address if the participant wishes to receive them. Participants who wish to 
receive study results at the conclusion of the study may provide the research 
team with their preferred method of receiving these results.
21.0
Resources
21.1 Per UH’s IRB policies, prior to being involved in the study, all key personnel will 
have: successfully completed the NIH or CITI Human Subjects Certificate of training 
modules; read the research protocols and plans for data and safety monitoring; and 
are familiar and have practiced with data collection. In addition, the PI and Co-PI       
have completed the CITI Responsible Conduct in Research training. The PI, Co-PI, 
grant coordinator will oversee data collection and review the progress of the study.
21.2 The Qigong instructor working for this study has worked with MD Anderson as part 
of the Integrative Medicine Center team, Baylor College of Medicine, Texas 
Woman’s Hospital and is currently at Rice University, sharing the health benefits of                 
Tai Chi, Qi Gong, Yoga and Meditation with patients, caregivers, students, faculty 
and staff.
22.0
Additional Approvals
22.1 This study has received agency approval from the MD Anderson Cancer 
Center. Please find attached the supporting letter from our study consultant, 
Dr. Lorenzo Cohen.
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