Clinical trial NCT04692233: Qigong to Improve Frailty Among Older Cancer Survivors
Official title: Qigong to Improve Frailty Among Older Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Frailty
Survivorship
Elderly
Keywords: Qigong
Baduanjin
Cancer survivors
Frailty
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 226
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. aged ≥65
2. diagnosed with stage I-III non-metastatic cancer
3. 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
4. classified as pre-frail or frail based on Fried frailty criteria
5. can communicate in Cantonese or Putonghua
6. written informed consent

Exclusion Criteria:

1. regular qigong training or other mind body intervention (once or more per week) within the previous 6 months
2. medical conditions affecting mobility, predisposing to falls, or precluding qigong practice (e.g., neurological disease, musculoskeletal disorder, recent myocardial infarction, breathing difficulties requiring oxygen)

Primary outcomes:
measure: Improvement in frailty status
timeFrame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary outcomes:
measure: Improvement in frailty scores
timeFrame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
measure: Physical performance
timeFrame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
measure: Psychological well-being
timeFrame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
measure: Health-related quality of life
timeFrame: at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
affiliation: The University of Hong Kong
name: Denise Shuk Ting Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: