Qigong to Improve Frailty Among Older Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 3
- 主要终点
- Improvement in frailty status
研究概览
简要总结
The objective of the study is to examine the effects of a 16-week Baduanjin qigong intervention on frailty, physical performance, psychological well-being, and health-related quality of life (HRQoL) among post-treatment older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 226 cancer survivors aged over 65 who have completed curative treatment and screened as pre-frail or frail will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will demonstrate greater reversed frailty status, more improvements in physical performance, better psychological well-being, and enhanced HRQoL compared to the control group. Study instruments will be Fried Phenotype Criteria, Edmonton Frail Scale, Short Physical Performance Battery, Geriatric Depression Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, and a background questionnaire. The intervention comprises of 1-hour qigong group training twice a week for 8 weeks, then 1-hour weekly follow-up group practice for 8 weeks and self-practice. The control group participants will attend light flexibility exercise group sessions at the same duration and frequency as the intervention group. Intention-to-treat analysis will be performed.
详细描述
The number of cancer survivors is rising worldwide. For example, in the United States, the number of cancer survivors is projected to increase by 31%, from 16.9 million in 2019 to 22.2 million by 2030, of which two-thirds are aged 65 or above. Hong Kong is also facing a growing number of cancer survivors, especially in older adults, due to advances in early detection and treatments and an aging population. The Hong Kong Cancer Strategy 2019 launched by the Hong Kong Government and Hospital Authority seeks to enhance cancer survivorship and surveillance management.
Older cancer survivors, making up the majority of survivors, tend to suffer from the combined effect of aging and long-term impacts of cancer, resulting in higher morbidity rates and poorer health-related quality of life than older adults without a cancer history. Tailored care for survivorship in older adults with cancer is highly important to reduce healthcare and economic burdens. In geriatric oncology, frailty status is an emerging health indicator with prognostic value. Nearly 80% of older cancer survivors have pre-frailty and frailty status that is linked to adverse health outcomes such as disability, impaired quality of life, falls, and death. There is a tremendous need to develop effective lifestyle interventions to reverse frailty status in the older cancer survivors. However, many clinical trials exclude participants older than 65 years old, and in real-world practice, many clinicians and policymakers advocate lifestyle modifications for older survivors less frequently than for younger survivors. The proposed project responds to an urgent research agenda in cancer survivorship that calls for interventions for addressing frailty.
The primary aim of this study is to evaluate the effect of a 16-week Baduanjin intervention on reversing frailty status among pre-frail and frail older cancer survivors. Reversal of frailty status is expected to be accompanied by improvements in patients' functioning, psychological well-being, and quality of life, and can reduce health service utilization and healthcare costs. Baduanjin is a simple form of qigong and can be performed by participants as and when needed after appropriate training. If the intervention proves effective, the widespread incorporation of qigong into treatment recommendations for cancer survivors can be easily translated into practice with little healthcare professional or patient burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization codes assignments. The group assignment will be sealed in separate opaque envelopes and centrally controlled. The BQ master and exercise trainer will not have knowledge about the aims of the study. The RAs responsible for assessing the outcomes and entering the data will be blinded to the group allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with stage I-III non-metastatic cancer
- •completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
- •classified as pre-frail or frail based on Fried frailty criteria
- •can communicate in Cantonese or Putonghua
- •written informed consent
排除标准
- •regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
- •medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)
结局指标
主要结局
Improvement in frailty status
时间窗: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Participants' frailty status will be assessed using the Fried frailty criteria, which consists of 5 criteria: slowness , weakness , unintentional weight loss , exhaustion and low activity. Patients with no criteria are considered robust, patients with 1 or 2 criteria are considered pre-frail, and patients with ≥3 criteria are considered frail.
次要结局
- Physical performance(at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention)
- Psychological well-being(at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention)
- Health-related quality of life(at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention)
- Improvement in frailty scores(at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention)
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong