Clinical trial NCT04019301: Caring for Caregivers With Mind-body Exercise
Official title: Caring for Caregivers With Mind-body Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Distress
Physical Function
Quality of Life
Keywords: Cancer Caregiver
Qigong
Feasibility
Caregiver distress
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Texas Woman's University
First posted: 2019-07-15
Enrollment: 47
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eligibility of recruited participants
timeFrame: 6 months
measure: Adherence to Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)
timeFrame: 6 months
measure: Brief Fatigue Inventory (BFI)
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances
timeFrame: 6 months
measure: Caregiver Burden Scale (CBS)
timeFrame: 6 months
measure: Godin Leisure-Time Exercise Questionnaire, Physical Activity
timeFrame: 6 months
measure: Self-Efficacy Scale, Exercise Self-Efficacy
timeFrame: 6 months
measure: Cognitive Function, Test 1
timeFrame: 6 months
measure: Cognitive Function, Test 2
timeFrame: 6 months
measure: Physical Function, Test 1
timeFrame: 6 months
measure: Physical Function, Test 2
timeFrame: 6 months
measure: Physical Function, Test 3
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Pinky Budhrani-Shani, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital and Harvard Medical School
name: Peter Wayne, PhD
role: PRINCIPAL_INVESTIGATOR
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