CancerNCT04694066
Qigong for Pre-frail and Frail Older Cancer Survivors
A study testing Qigong and Light flexibility exercise in people with Cancer and Frailty, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- What is being tested?
- Qigong and Light flexibility exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Aug 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged ≥65
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong, 000
Pamela Youde Nethersole Eastern Hospital
Hong Kong
About this study
Official title: Qigong for Pre-frail and Frail Older Cancer Survivors: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Qigong, Light flexibility exercise
- Keywords
- Frailty, Cancer survivors, Qigong, Feasibility
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongBehavioural
Qigong Baduanjin, comprising eight standardized movements, will be adopted in the study. It is practiced as a combination of body movements, breath control, and mindful meditation.
Light flexibility exerciseBehavioural
The supervised sessions will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | The entire intervention will last 16 weeks, including 1-hour supervised training sessions twice a week during weeks 1 to 8 (training; 16 hours), and 1-hour supervised weekly follow-up sessions during weeks 9 to 16 (followup; 8 hours). The sessions will be supervised by an experienced qigong master. Receives: Behavioral: Qigong |
| Light flexibility exercise | Active comparator | The control group will practice light flexibility exercise only, with the same duration and frequency of supervised sessions identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer. Receives: Behavioral: Light flexibility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Study completion rate
The proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Measured: 16 weeks
Feasibility: Attendance rate
Participants' attendance to the supervised sessions will be recorded at each time point.
Measured: 16 weeks
Secondary outcomes (5)
Change 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.
Measured: study entry, 8 weeks, 16 weeks
Change in Short Physical Performance Battery scores
Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.
Measured: study entry, 8 weeks, 16 weeks
Change in Short-Form Geriatric Depression Scale scores
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.
Measured: study entry, 8 weeks, 16 weeks
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores
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.
Measured: study entry, 8 weeks, 16 weeks
Change in Modified Barthel Index scores
The Modified Barthel Index will be used to measure participants' performance in activities of daily living such as eating, personal hygiene, and bathing, rated on an arbitrary 2- to 4-point scale depending on the amount of assistance needed. Scores range from 0 (an inability to perform) to 15 (total independence).
Measured: study entry, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Aug 2019
- Primary completion28 Feb 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Shuk-Ting, The University of Hong Kong
- Investigators
- Denise Cheung, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694066
- Sponsor's protocol ID
- HKUCTR-2708
- Status last verified
- Nov 2022
- First submitted
- 30 Dec 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available upon reasonable request.
Publications
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.
PubMed 35272982
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qigong for Pre-frail and Frail Older Cancer Survivors: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04694066
- Acronym / sponsor ID
- HKUCTR-2708
- Keywords
- Frailty, Cancer survivors, Qigong, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: QigongThe entire intervention will last 16 weeks, including 1-hour supervised training sessions twice a week during weeks 1 to 8 (training; 16 hours), and 1-hour supervised weekly follow-up sessions during weeks 9 to 16 (followup; 8 hours). The sessions will be supervised by an experienced qigong master. |
| Light flexibility exercise | Active comparator | Behavioral: Light flexibility exerciseThe control group will practice light flexibility exercise only, with the same duration and frequency of supervised sessions identical to the qigong sessions. The supervised sessions will be conducted by a certified exercise trainer. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- aged ≥65
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QigongQigong Baduanjin, comprising eight standardized movements, will be adopted in the study. It is practiced as a combination of body movements, breath control, and mindful meditation. | Behavioural | Qigong |
| Light flexibility exerciseThe supervised sessions will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations. | Behavioural | Light flexibility exercise |
Primary outcome
Feasibility: Study completion rate
Time frame: 16 weeks
The proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Feasibility: Attendance rate
Time frame: 16 weeks
Participants' attendance to the supervised sessions will be recorded at each time point.
5 secondary outcomes
Change in frailty status
Time frame: study entry, 8 weeks, 16 weeks
Change in Short Physical Performance Battery scores
Time frame: study entry, 8 weeks, 16 weeks
Change in Short-Form Geriatric Depression Scale scores
Time frame: study entry, 8 weeks, 16 weeks
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores
Time frame: study entry, 8 weeks, 16 weeks
Change in Modified Barthel Index scores
Time frame: study entry, 8 weeks, 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 35272982Cheung 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.
- Individual participant dataSharing planned: Undecided. Data may be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Cheung principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and Light flexibility exercise in people with Cancer and Frailty, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Study completion rate (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.