Qigong to Improve Frailty Among Older Cancer Survivors

Cancer Clinical Trial

Official title:

Qigong to Improve Frailty Among Older Cancer Survivors: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692233
• Other study ID #: UW19550
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: Denise Shuk Ting Cheung, PhD
• Phone: 39176676
• Email: denisest[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Elderly
• Frailty
• Survivorship

Intervention

Behavioral:
• Qigong Baduanjin
Qigong Baduanjin will comprise eight standardized movements. It is practiced as a combination of body movements, breath control, and mindful meditation, which is designed to improve qi function.
• Light flexibility exercise
Each session will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, back, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in frailty status	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.	at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary	Improvement in frailty scores	The Edmonton Frail Scale will be used to capture changes in frailty as a continuous score. As a multidimensional view, it will complement the physical-based Fried criteria regarding the intervention effect. The scale consists of 11 items, which cover nine domains (cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance). The higher total scores represent more severe frailty states.	at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary	Physical performance	Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.	at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary	Psychological well-being	The Short-Form Geriatric Depression Scale (15 items) will be used to measure psychological well-being. Scores range from 0 to 15, with higher scores representing more severe depressive symptoms.	at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention
Secondary	Health-related quality of life	European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 (30 items) will be used to assess health-related quality of life specifically in cancer patients. The questionnaire is composed of five functional scales, three symptom scales, a global health status / QoL scale, and six single items. scale. Scores of all subscales and single-item measures range from 0 to 100. Higher scores for functional scales represent higher level of functioning, global health status/quality of life, but higher scores for a symptom scale / item represent a higher level of symptom severity.	at study entry, post-training, post-intervention, 6 months post intervention, 12 months post intervention