Caring for Caregivers With Mind-body Exercise
试验速览
- 阶段
- 不适用
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Eligibility of recruited participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Eligibility of recruited participants
时间窗: 6 months
Eligibility assessed by the % of eligible participants that are willing to consent to participate in the study.
Adherence to Intervention
时间窗: 6 months
Intervention adherence assessed by the rate of compliance with classes and home practice.
次要结局
- Godin Leisure-Time Exercise Questionnaire, Physical Activity(6 months)
- Self-Efficacy Scale, Exercise Self-Efficacy(6 months)
- Cognitive Function, Test 2(6 months)
- Pittsburgh Sleep Quality Index (PSQI), Sleep Disturbances(6 months)
- Caregiver Burden Scale (CBS)(6 months)
- Physical Function, Test 1(6 months)
- Physical Function, Test 3(6 months)
- Center for Epidemiological Studies Depression Scale Revised (CESD-R-10)(6 months)
- Physical Function, Test 2(6 months)
- Brief Fatigue Inventory (BFI)(6 months)
- Cognitive Function, Test 1(6 months)