Caring for Caregivers With Mind-body Exercise

December 9, 2021 updated by: University of Houston
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77004
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligibility of recruited participants
Time Frame: 6 months
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
6 months
Adherence to Intervention
Time Frame: 6 months
Intervention adherence assessed by the rate of compliance with classes and home practice.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)
Time Frame: 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.
6 months
Brief Fatigue Inventory (BFI)
Time Frame: 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.
6 months
Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances
Time Frame: 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.
6 months
Caregiver Burden Scale (CBS)
Time Frame: 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.
6 months
Godin Leisure-Time Exercise Questionnaire, Physical Activity
Time Frame: 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.
6 months
Self-Efficacy Scale, Exercise Self-Efficacy
Time Frame: 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.
6 months
Cognitive Function, Test 1
Time Frame: 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.
6 months
Cognitive Function, Test 2
Time Frame: 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.
6 months
Physical Function, Test 1
Time Frame: 6 months
Grip strength: Strength of the dominant hand will be measured using a Jamar hydraulic hand dynamometer (Patterson Medical - Canada, Mississauga, ON, CAN).
6 months
Physical Function, Test 2
Time Frame: 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.
6 months
Physical Function, Test 3
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 22, 2019

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (ACTUAL)

July 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R34AT010081 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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