Caring for Caregivers With Mind-body Exercise

Sponsor

University of Houston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04019301

Collaborator

Brigham and Women's Hospital (Other), Texas Woman's University (Other)

Enrollment

Location

Arms

39.3

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study will lay the foundation for the first large-scale trial evaluating the psychosocial and physical health benefits of a widely available and promising Qigong intervention (Eight Brocades) for distressed cancer caregivers (CCGs). CCGs 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 well-being. This pilot study, and the 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 trial will be the first to explore the delivery of Qigong to caregivers using an internet-based program, potentially leading to wider accessibility to mind-body therapies, and providing an alternative to community-based group-class learning.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Distress Physical Function Quality of Life	Other: Baduanjin Qigong, Community-based Other: Baduanjin Qigong, Internet-based	N/A

Detailed Description

Caregivers (CGs) often experience significant psychological and physical distress leading to marked reductions in caregivers' health and quality of life (QOL). Reducing CG distress has the potential to improve CG mental and physical health, improve overall QOL, and lead to improvements in the care they provide.

However, few effective interventions that can be widely delivered and easily adhered to have been rigorously evaluated. 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 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. A robust evidence base supports that Qigong and Tai Chi training in groups can improve multiple domains of physical and emotional health, QOL, and selfefficacy in diverse populations. Of note, recent national surveys indicate that a significant proportion of the US population that report using Qigong and Tai Chi for health preferred self-directed learning from DVDs and internet resources. While a handful of studies support the potential for web-based or DVD-based learning of mind-body practices, evaluations of such programs have not been well-tested, especially in CGs.

Using cancer caregivers (CCGs) as a representative population of the larger CG population, the longterm goal is to conduct a definitive trial evaluating a widely accessible and previously studied Qigong regimen (Eight Brocades, Baduanjin Qigong). Interventions will be delivered either in community-based groups led by instructors or via internet to individuals learning through recorded guided instruction supplemented with intermittent virtual live feedback from instructors. Outcomes will include QOL, fatigue, sleep disturbances, psychological distress, caregiver 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. The investigators will address these goals by randomizing (1:1:1) 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.

Specific Aim 1 is to finalize Qigong intervention content and delivery protocols. Specific Aim 2 will assess the 'learnability' of Qigong delivered in community-based group classes and via a web-based protocol using a novel proficiency instrument. Specific Aim 3 will evaluate the feasibility of recruiting and retaining CCGs into a 12-week clinical trial, and completing all outcomes testing protocols. Study feasibility and merit will be further informed by formal qualitative analysis of exit interviews of study completers, participants that withdraw, and Qigong instructors.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cancer caregivers will be randomized to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.Cancer caregivers will be randomized to one of three conditions: (1) a community-based qigong program; (2) an internet-based qigong program; or (3) a self-care control group.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Caring for Caregivers With Mind-body Exercise

Actual Study Start Date :

Apr 22, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community-based Qigong Group Participants randomized into this group follow one, 75 minutes class per week supplemented by home practice for 20 minutes on 3 additional days.	Other: Baduanjin Qigong, Community-based The Community-based Qigong group, will attend one 75 minute long Qigong class per week for 12 weeks. Additionally, participants practice Qigong at home for 20 minutes a day, 3 days a week. Printed materials will be provided to guide home practice. Other Names: Eight Brocades Regimen
Experimental: Internet-based Qigong Group Participants randomized into this group follow two online sessions for 40 minutes each, also supplemented by home practice for 20 minutes on 3 additional days.	Other: Baduanjin Qigong, Internet-based The Internet-guided Qigong group will be given a computer tablet to access online Qigong classes. All participants assigned to this group will be provided with a tutorial to use the Qigong program by the research coordinator. Participants will be asked to follow a 40 minute long Qigong class twice a week for 12 weeks, and to practice an additional 20 minutes a day, 3 days a week. All sessions will be completed at home. Other Names: Eight Brocades Regimen
No Intervention: Self-Care Control Group The Self-care control group, will be requested not to practice any Qigong during the study. Participants will be provided with an educational book on caregiving that includes self-guided activities related to caregiving and caregiver health (The Caregiver Helpbook: Powerful Tools for Caregiving). The book's evidence-based program is designed to provide caregivers the tools to increase their self-care and their confidence to handle difficult situations, emotions, and decisions. In addition, study staff will call participants in the self-care control group once a month.

Arm

Intervention/Treatment

Experimental: Community-based Qigong Group

Participants randomized into this group follow one, 75 minutes class per week supplemented by home practice for 20 minutes on 3 additional days.

Other: Baduanjin Qigong, Community-based

The Community-based Qigong group, will attend one 75 minute long Qigong class per week for 12 weeks. Additionally, participants practice Qigong at home for 20 minutes a day, 3 days a week. Printed materials will be provided to guide home practice.

Other Names:

Eight Brocades Regimen

Experimental: Internet-based Qigong Group

Participants randomized into this group follow two online sessions for 40 minutes each, also supplemented by home practice for 20 minutes on 3 additional days.

Other: Baduanjin Qigong, Internet-based

The Internet-guided Qigong group will be given a computer tablet to access online Qigong classes. All participants assigned to this group will be provided with a tutorial to use the Qigong program by the research coordinator. Participants will be asked to follow a 40 minute long Qigong class twice a week for 12 weeks, and to practice an additional 20 minutes a day, 3 days a week. All sessions will be completed at home.

Other Names:

Eight Brocades Regimen

No Intervention: Self-Care Control Group

The Self-care control group, will be requested not to practice any Qigong during the study. Participants will be provided with an educational book on caregiving that includes self-guided activities related to caregiving and caregiver health (The Caregiver Helpbook: Powerful Tools for Caregiving). The book's evidence-based program is designed to provide caregivers the tools to increase their self-care and their confidence to handle difficult situations, emotions, and decisions. In addition, study staff will call participants in the self-care control group once a month.

Outcome Measures

Primary Outcome Measures

Eligibility of recruited participants [6 months]
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
Adherence to Intervention [6 months]
Intervention adherence assessed by the rate of compliance with classes and home practice.

Secondary Outcome Measures

Center for Epidemiological Studies Depression Scale Revised (CESD-R-10) [6 months]
Self-report measure of depression consisting of 10-items. Total score is calculated based on the sum of 10 items. Each item is scored 0 to 3 yielding a total between 0 and 30. Any score equal to or greater than 10 is considered depressed.
Brief Fatigue Inventory (BFI) [6 months]
Self-report measure of fatigue consisting of 9 items measuring the severity of fatigue and the impact of fatigue on daily functioning in the past 24 hours. Each item is scored 0-10 where 0 is no fatigue and 10 is bad fatigue, yielding a total between 0 and 90.
Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances [6 months]
Self-report measure of sleep disturbance consisting of 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. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed up to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Caregiver Burden Scale (CBS) [6 months]
Self-report measure of caregiver burden consisting of 22 items measuring the impact of caregiving on three dimensions of burden: objective, subjective demand, and subjective stress. Each item is scored 0-4 (0=never; 4=nearly always), yielding a total between 0 and 88. Higher scores represent a worse outcome.
Godin Leisure-Time Exercise Questionnaire, Physical Activity [6 months]
Self-report measure of exercise consisting of 4 items measuring the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. Each item is scored using units for strenuous exercise, moderate exercise, and mild exercise. Higher units represent a better outcome.
Self-Efficacy Scale, Exercise Self-Efficacy [6 months]
Self-report measure of self-efficacy consisting of 9 items measuring self-efficacy expectations related to the ability to continue exercising in the face of barriers to exercise. Each item is scored 0-10 (0 = not confident; 10 = very confident), yielding a total between 0 and 90. Higher values represent a better outcome.
Cognitive Function, Test 1 [6 months]
Digit Span. Participants will be asked to repeat numbers in a specific order. Performance is indicated by the average number of digits correctly remembered.
Cognitive Function, Test 2 [6 months]
Trail Making Test Parts A & B. Participants are timed as they connect 25 circles without lifting the pen or pencil from the paper.
Physical Function, Test 1 [6 months]
Grip strength: Strength of the dominant hand will be measured using a Jamar hydraulic hand dynamometer (Patterson Medical - Canada, Mississauga, ON, CAN).
Physical Function, Test 2 [6 months]
Sit-to-stand. Participants will be asked to sit in a chair, cross their arms over their chest, and stand without the assistance of their arms. Number of times this is completed in 30 seconds will be recorded.
Physical Function, Test 3 [6 months]
Balance. Participants will perform a static single-leg postural control balance test twice, once with eyes open and once with eyes closed. The maximum time for both will be limited to 30 seconds.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant is a spouse, partner, family member, or friend providing physical, emotional, and/or financial support for a cancer patient.
Participant is able to understand, speak, and read English.
Participant has a minimum level of 3 on the National Comprehensive Cancer Network's (NCCN) Distress Thermometer adapted for caregivers.
Participant is able to provide informed consent.

Exclusion Criteria:

Participant does not have an unstable illness (e.g., recent hospitalization, unstable cardiovascular disease, active cancer).
Participant does not have a psychiatric disorders (e.g., unmanaged depression or psychosis, substance abuse, severe personality disorder)
Participant does not have a degenerative neuromuscular condition (e.g., Parkinson's disease, multiple sclerosis).
Participant does not have an inability to walk continuously for 15 minutes.
Participant does not have a 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.
Participation is not currently engaged in more than 240 minutes of moderate-intensity exercise per week.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston	Houston	Texas	United States	77004

Sponsors and Collaborators

University of Houston
Brigham and Women's Hospital
Texas Woman's University

Investigators

Principal Investigator: Pinky Budhrani-Shani, PhD, MSN, RN, University of Houston
Principal Investigator: Peter Wayne, PhD, Brigham and Women's Hospital and Harvard Medical School