TY - JOUR
T1 - Qigong mind-body program for caregivers of cancer patients
T2 - design of a pilot three-arm randomized clinical trial
AU - Shani, Pinky
AU - Raeesi, Kristin
AU - Walter, Eli
AU - Lewis, Kai
AU - Wang, Wanyi
AU - Cohen, Lorenzo
AU - Yeh, Gloria Y.
AU - Lengacher, Cecile A.
AU - Wayne, Peter M.
N1 - Funding Information:
This study is supported by grants from the National Center for Complementary and Integrative Health/ National Institutes of Health (R34AT010081 and K24AT009282).
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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
AB - 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
KW - Cancer caregivers
KW - Distress
KW - Internet
KW - Qigong
KW - Quality of life
KW - Randomized control trial
KW - Study protocol
KW - feasibility
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UR - http://www.scopus.com/inward/citedby.url?scp=85102712295&partnerID=8YFLogxK
U2 - 10.1186/s40814-021-00793-4
DO - 10.1186/s40814-021-00793-4
M3 - Article
C2 - 33741070
AN - SCOPUS:85102712295
SN - 2055-5784
VL - 7
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 73
ER -