Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
47 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-04-22
Study Completion Date
2022-08-31
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Caregiver Distress
Physical Function
Quality of Life
Keywords
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Cancer Caregiver
Qigong
Feasibility
Caregiver distress
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Baduanjin Qigong, Community-based
Intervention Type
OTHER
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.
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.
Group Type
EXPERIMENTAL
Baduanjin Qigong, Internet-based
Intervention Type
OTHER
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.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Other Intervention Names
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Eight Brocades Regimen
Eight Brocades Regimen
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
35 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Sponsor Role
collaborator
Texas Woman's University
OTHER
Sponsor Role
collaborator
University of Houston
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pinky Budhrani-Shani, PhD, MSN, RN
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Peter Wayne, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital and Harvard Medical School
Locations
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University of Houston
Houston, Texas, United States
Site Status
Countries
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United States
References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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