Clinical trial NCT04694066: Qigong for Pre-frail and Frail Older Cancer Survivors
Official title: Qigong for Pre-frail and Frail Older Cancer Survivors: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Frailty
Keywords: Frailty
Cancer survivors
Qigong
Feasibility
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To-date, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

Detailed description: Frailty is an emerging concept in geriatric research and practice. It is defined as a state of increased vulnerability to adverse outcomes including death. A cohort study has found that respondents with cancer were significantly more frail compared to those without cancer. A plausible explanation is both cancer itself and the therapies used to treat it add additional stressors that challenge a patient's physiologic reserve. A systematic review has revealed a high prevalence of frailty and pre-frailty in older cancer patients, with the median estimates of 42% and 43%, respectively. Cancer treatment can hasten survivors' aging process and increase their risk of developing frailty, thus placing cancer survivors at heightened risk of such poor health outcomes as falls, fractures, and disability. This calls for effective interventions that would improve frailty in older cancer survivors.

Qigong, a type of mind-body intervention, is particularly suitable for older adults, as it is implemented without aerobic and musculoskeletal strain. This equipment-free form of exercise is ideal for settings with limited resources, as well as for the frail elderly, because it can be performed at home at any time, reducing such barriers as weather, transportation, and cost. Meta-analysis suggests that Baduanjin is beneficial in the general population in terms of improved quality of life, balance, handgrip strength, and trunk flexibility. To our knowledge, there is no evidence on qigong's effects for improving well-being of pre-frail and frail older cancer survivors. Our aim is therefore to conduct a pilot study for testing out the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.

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: Feasibility: Study completion rate
timeFrame: 16 weeks
measure: Feasibility: Attendance rate
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in frailty status
timeFrame: study entry, 8 weeks, 16 weeks
measure: Change in Short Physical Performance Battery scores
timeFrame: study entry, 8 weeks, 16 weeks
measure: Change in Short-Form Geriatric Depression Scale scores
timeFrame: study entry, 8 weeks, 16 weeks
measure: Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores
timeFrame: study entry, 8 weeks, 16 weeks
measure: Change in Modified Barthel Index scores
timeFrame: study entry, 8 weeks, 16 weeks
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 Cheung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung DST, Chau PH, Lam TC, Ng AYM, Kwok TWH, Takemura N, Woo J, Yu DS, Lin CC. A pilot randomized controlled trial using Baduanjin qigong to reverse frailty status among post-treatment older cancer survivors. J Geriatr Oncol. 2022 Jun;13(5):682-690. doi: 10.1016/j.jgo.2022.02.014. Epub 2022 Mar 7.