Shani Pinky, Raeesi Kristin, Walter Eli, Lewis Kai, Wang Wanyi, Cohen Lorenzo, Yeh Gloria Y, Lengacher Cecile A, Wayne Peter M
University of Houston, College of Nursing, Houston, TX, USA.
Texas Woman's University, College of Nursing, Houston, TX, USA.
Pilot Feasibility Stud. 2021 Mar 19;7(1):73. doi: 10.1186/s40814-021-00793-4.
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.
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.
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.
NCT04019301 ; registered on July 15, 2019; clinicaltrials.gov.
非正式照料者，通常是家人和朋友，会经历显著的心理和身体痛苦，导致健康状况和生活质量（QOL）下降。针对照料者的身心干预往往有限，且未解决多种障碍，包括照料者的经济、地理和时间限制。将基于社区的面对面干预转化为基于互联网的干预可能会为照料者提供更大的可及性，从而提高依从性。
“照料者的身心关怀”实施一项三臂试点随机对照试验，以评估向癌症照料者提供气功干预（八段锦）的可行性。总共54名癌症照料者将被随机分为三个为期12周的项目之一：（1）基于社区的气功项目，（2）基于互联网的气功项目，或（3）自我护理对照组。具体研究目标包括：（1）修改在线干预内容，（2）评估招募和留住癌症照料者参加为期12周临床试验的可行性，（3）评估收集和管理数据的可行性以及问卷对该人群的适用性。将评估多个结果，包括照料者的生活质量、照料负担、照料者痛苦、感知到的社会支持、身体功能和认知功能。6个月的随访还将评估生活质量和心理社会幸福感的长期变化。
研究结果将用于为一项大规模比较效果试验的设计和实施提供信息，该试验评估通过基于社区和基于互联网的项目接受气功训练的照料者。发现其中一个或两个项目有效将为照料者的护理和选择提供信息。
NCT04019301；于2019年7月15日注册；clinicaltrials.gov。
