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Qigong for Pre-frail and Frail Older Cancer Survivors

Primary Purpose

Cancer, Frailty

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Qigong
Light flexibility exercise
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Frailty, Cancer survivors, Qigong, Feasibility

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Queen Mary Hospital
  • Pamela Youde Nethersole Eastern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qigong

Light flexibility exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility: Study completion rate
The proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Feasibility: Attendance rate
Participants' attendance to the supervised sessions will be recorded at each time point.

Secondary Outcome Measures

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.
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.
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.
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.
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).

Full Information

First Posted
December 30, 2020
Last Updated
November 19, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04694066
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Frailty
Keywords
Frailty, Cancer survivors, Qigong, Feasibility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The care providers, though cannot be blinded, will not have knowledge about the aims of the study. The research assistants responsible for assessing the outcomes and entering the data will be blinded to the group. allocation.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qigong
Arm Type
Experimental
Arm Description
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.
Arm Title
Light flexibility exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Qigong
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Light flexibility exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: Study completion rate
Description
The proportion of participants who completed the data collection among those randomized will be recorded at each time point.
Time Frame
16 weeks
Title
Feasibility: Attendance rate
Description
Participants' attendance to the supervised sessions will be recorded at each time point.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in frailty status
Description
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.
Time Frame
study entry, 8 weeks, 16 weeks
Title
Change in Short Physical Performance Battery scores
Description
Short Physical Performance Battery is an objective assessment tool used to measure the physical performance of participants in three functional tasks.
Time Frame
study entry, 8 weeks, 16 weeks
Title
Change in Short-Form Geriatric Depression Scale scores
Description
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.
Time Frame
study entry, 8 weeks, 16 weeks
Title
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30 scores
Description
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.
Time Frame
study entry, 8 weeks, 16 weeks
Title
Change in Modified Barthel Index scores
Description
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).
Time Frame
study entry, 8 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Cheung
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
000
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be available upon reasonable request.
Citations:
PubMed Identifier
35272982
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.
Results Reference
derived

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Qigong for Pre-frail and Frail Older Cancer Survivors

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