Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial
Abstract Background Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including car...
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doaj-766208371705461c9ae763ff2c4df43e2021-03-21T12:17:23ZengBMCPilot and Feasibility Studies2055-57842021-03-017111210.1186/s40814-021-00793-4Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trialPinky Shani0Kristin Raeesi1Eli Walter2Kai Lewis3Wanyi Wang4Lorenzo Cohen5Gloria Y. Yeh6Cecile A. Lengacher7Peter M. Wayne8University of Houston, College of NursingTexas Woman’s University, College of NursingUniversity of Houston, College of NursingHouston Martial Arts AcademyTexas Woman’s University, College of NursingThe University of Texas MD Anderson Cancer CenterBeth Israel Deaconess Medical Center, Harvard Medical SchoolUniversity of South Florida, College of NursingOsher Center for Integrative Medicine, Harvard Medical School and Brigham and Women’s HospitalAbstract Background Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers’ economic, geographic, and time constraints. Translation of in-person, community-based interventions to Internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence. Methods Caring for Caregivers with Mind-Body implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong, (2) Internet-based Qigong, or (3) a self-care control group. Study-specific aims include (1) modify intervention content for online delivery, (2) evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial, and (3) evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial well-being. Discussion Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs Internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers. Trial registration NCT04019301 ; registered on July 15, 2019; clinicaltrials.govhttps://doi.org/10.1186/s40814-021-00793-4Cancer caregiversQigongfeasibilityRandomized control trialStudy protocolInternet |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Pinky Shani Kristin Raeesi Eli Walter Kai Lewis Wanyi Wang Lorenzo Cohen Gloria Y. Yeh Cecile A. Lengacher Peter M. Wayne |
spellingShingle |
Pinky Shani Kristin Raeesi Eli Walter Kai Lewis Wanyi Wang Lorenzo Cohen Gloria Y. Yeh Cecile A. Lengacher Peter M. Wayne Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial Pilot and Feasibility Studies Cancer caregivers Qigong feasibility Randomized control trial Study protocol Internet |
author_facet |
Pinky Shani Kristin Raeesi Eli Walter Kai Lewis Wanyi Wang Lorenzo Cohen Gloria Y. Yeh Cecile A. Lengacher Peter M. Wayne |
author_sort |
Pinky Shani |
title |
Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
title_short |
Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
title_full |
Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
title_fullStr |
Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
title_full_unstemmed |
Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
title_sort |
qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial |
publisher |
BMC |
series |
Pilot and Feasibility Studies |
issn |
2055-5784 |
publishDate |
2021-03-01 |
description |
Abstract Background Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers’ economic, geographic, and time constraints. Translation of in-person, community-based interventions to Internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence. Methods Caring for Caregivers with Mind-Body implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong, (2) Internet-based Qigong, or (3) a self-care control group. Study-specific aims include (1) modify intervention content for online delivery, (2) evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial, and (3) evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial well-being. Discussion Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs Internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers. Trial registration NCT04019301 ; registered on July 15, 2019; clinicaltrials.gov |
topic |
Cancer caregivers Qigong feasibility Randomized control trial Study protocol Internet |
url |
https://doi.org/10.1186/s40814-021-00793-4 |
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