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Trial registered on ANZCTR


Registration number
ACTRN12623000177651
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
21/02/2023
Date last updated
1/12/2024
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Baduanjin mind-body exercise for cancer-related fatigue
Scientific title
Baduanjin mind-body exercise for cancer-related fatigue in cancer participants receiving adjuvant chemotherapy: a randomised control feasibility trial
Secondary ID [1] 308879 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-related fatigue 328871 0
Condition category
Condition code
Cancer 325865 325865 0 0
Any cancer
Physical Medicine / Rehabilitation 325996 325996 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 330788 330788 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baduanjin mind-body exercise involves a set of gentle aerobic exercises involving mental focus with controlled breathing while performing a sequenced set of coordinated physical movements. According to the American Sports Medicine Association and the American Centres for Disease Control and Prevention, Baduanjin MBE is a low-intensity exercise.

Baduanjin mind-body exercise program is in addition to a participant’s standard care. There are no changes to a participant’s usual care practices. Participants commencing the exercise program will have a meeting with a research team member (in week 0), who will organise delivery of the information pack and resources in advance of the participant commencing their Baduanjin mind-body exercise in Week 1. An introductive session (30-minute) is held for participants individually, which is comprised of an introduction to the Baduanjin mind-body exercise program, guidelines for performing the exercise movements, instructions related to the Exercise Logbook to record the completion of the daily exercise routine. The picture-based Instruction Handbook (brochure) displaying the movements and Baduanjin mind-body exercise online demonstration video link will be provided to the patient in Week 1. The picture-based Instruction Handbook (brochure) and Exercise Logbook are sent to the participant by email (only mailing hard copies as required). The picture-based Instruction Handbook is produced by the research team, the demonstration video is accessible via a YouTube link (https://youtu.be/F5OtK935Y8w). This is an information session (in week 0), no instructions on how to perform the exercise is given until one week after (in week 1), that is, the participants are required not to commence their Baduanjin mind-body exercise.

After receiving the study information pack and resources, a Baduanjin mind-body exercise instructor (who is a member of the research team) will organise a Zoom meeting to meet with each participant to explain and demonstrate the eight movements and natural breathing methods that comprise the Baduanjin mind-body exercise program. Using the Zoom App, participants will be invited to watch the Baduanjin mind-body exercise demonstration videos which explains how to perform the exercise movements where the instructor will explain and demonstrate the eight movements and natural breathing methods with the participants. This is done before commencing the first exercise session in the program.

In addition to self-guided practice, the participants will be asked to join in a coached Zoom exercise program with an instructor, either in the morning or afternoon or both sessions at their own choice throughout the intervention period (8 weeks). Participants will be requested to practice Baduanjin mind-body exercise at least 2 sessions per day, 6 days per week with each session lasting about 17-20 mins for 8 weeks. Missed sessions will not be considered as a protocol deviation.

The Baduanjin mind-body exercise sessions via Zoom are instructed by members of the research team who have at least two years' experience in the practice of Baduanjin mind- body exercise. If participants miss out on any Zoom sessions, they can watch the demonstration video as a reference. Participants will be asked to record their daily Baduanjin mind-body exercise schedule in the Exercise Logbook. Recording this in Exercise Logbook will take approximately 2 minutes each session. This will happen twice daily, 6 times per week for 8 weeks. Weekly telephone calls will be performed by a research assistant to see how the participants are progressing and engaging with the Baduanjin mind-body exercise program. The weekly phone calls will also discuss any unexpected side effects or adverse events that might be related to the exercise.

Finally, participants are asked to complete two (2) questionnaires at baseline (week 0) as part of the study intake process, and again at the end of week 4 and week 8 of the exercise program. These questionnaires are the brief fatigue inventory (BFI) and the PROMIS-29v2.0. The BFI measures fatigue. The PROMIS-29v2.0 is a patient reported outcome measure used by health services in NSW. Together, these will take 5-10 minutes to complete online and can be accessed using secure links that will be emailed to participants. There is also the Credibility and Expectancy Questionnaire (CEQ) which has four questions and takes one minute to complete. Two questions are completed before entry into the study (week 0), and two at the completion of the Baduanjin mind-body exercise program (week 9). One week after completing the Baduanjin mind-body exercise program (in week 9), a study team member will contact participants by phone for a final time. This is to check on the participant and see if there have any reports or adverse experiences. Participants will also be asked to complete for the final time the BFI and the PROMIS-29v2.0, along with the final two questions from the CEQ. This also includes two open questions for participants to provide feedback.
Intervention code [1] 325324 0
Treatment: Other
Intervention code [2] 325430 0
Lifestyle
Comparator / control treatment
From week 0 to week 9 (10 weeks in total), participants will receive their usual care/medications and undergo no Baduanjin mind-body exercise intervention. Participants in the waitlist control group also maintain their lifestyle without modifications to usual daily care routines. Participants will be asked to complete the BFI and the PROMIS-29v2.0 questionnaires to monitor changes in their cancer-related fatigue to compare changes with the intervention group. This will happen upon enrolment into the study (week 0 - baseline), and at week 4, week 8 and again at week 9. Participants in the waitlist control will be offered entry into the Baduanjin mind-body exercise program at completion of their waitlist control period. Entry will be as a non-study participant which means access to the exercise program but without any further need to complete questionnaires. This is voluntary and no longer as part of the study.
Control group
Active

Outcomes
Primary outcome [1] 333693 0
Feasibility - recruitment rate information collected from study records including number of enquires and number of enrolments. Calculate percentage conversion to enrolment measured as participants (n) enrolled / the total number of enquiries; and participants (n) enrolled / people (n) potentially eligible.
Timepoint [1] 333693 0
Assessed at monthly timepoints for up to 12 months post-first enrolment.
Primary outcome [2] 333851 0
Feasibility - retention rate collected from study records. Calculate participants (n) completing 8-week intervention (96 sessions) and outcome measures/ participants (n) enrolled.
Timepoint [2] 333851 0
Assessed at monthly timepoints for up to 12 months post-first enrolment.
Primary outcome [3] 333852 0
Feasibility - adherence rate collected from study records. Calculate participants (n) completing at least 80% or 10 out of 12 Baduanjin mind-body exercise days per week / total participants (n) allocated to the intervention group.
Timepoint [3] 333852 0
Assessed at monthly timepoints for up to 12 months post-first enrolment.
Secondary outcome [1] 417966 0
Change in the severity of cancer-related fatigue symptoms measured by the Brief Fatigue Inventory (BFI).
Timepoint [1] 417966 0
Week 0 (baseline), week 4 (mid-point), week 8 (final week) and week 9 (1 week follow-up)
Secondary outcome [2] 417968 0
Change in any of health domains in physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance measured by PROMIS–29 Profile v2.0.
Timepoint [2] 417968 0
Week 0 (baseline), week 4 (mid-point), week 8 (final week) and week 9 (1 week follow-up)
Secondary outcome [3] 417969 0
The number and severity of reported side effects and / or adverse events.
Timepoint [3] 417969 0
Outcome is continuously collected as participants can self report. Weekly phone calls (up to week 9) will also be made to discuss any unexpected side effects or adverse events that might be related to the exercise.
Secondary outcome [4] 417971 0
Participant’s perceptions of the Baduanjin mind-body exercise program before randomisation and after completion of the program as measured by the (modified) Credibility and Expectancy Questionnaire.
Timepoint [4] 417971 0
Week 0 (baseline), and week 9 (1 week follow-up).

Eligibility
Key inclusion criteria
The inclusion criteria are: (1) 18 years of age or older; (2) receiving adjuvant chemotherapy or completed adjuvant chemotherapy; (3) medical history of cancer diagnosis; (4) suffering from moderate CRF (rating of 4 to 6) as assessed by the BFI simple fatigue scale; (5) have a computer / device that is Wi-Fi or hotspot connected and be able to use smart phones, email, phone camera, (such as Facetime on iPhone), and Zoom conferencing app; (6) be aware of one’s cancer diagnosis; and (7) understand the intervention process and able to communicate and provide informed consent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: (1) uncontrolled cardiopulmonary disease, angina, uncontrolled hypertension or uncontrolled postural hypotension; (2) uncontrolled nerve, muscle, or joint disease or injury affecting coordinated movement; (3) psychiatric illness or serious cognitive impairment and communication or language barriers that effect informed consent; (4) postoperative heart, cerebral vessel, or other serious complications; (5) those not fully recovered from breast surgery, axillary surgery, transabdominal rectus abdominus muscle reconstructive surgery or any other surgery that would preclude full participation in the program, (6) if an individual is otherwise not approved by their oncologist as being potentially eligible; (7) enrolled in other investigational studies which would impact cancer-related fatigue; and (8) a recent history (within previous 3 months) of regularly participating in Baduanjin mind-body exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list will be created using an online randomization tool. The list is generated by a research team member independent from the trial manager. The list will allocate 40 participants to one of two (2) equal sized groups (treatment and waitlist) in blocks of four (4) to assist with equitable participant allocation between groups throughout the recruitment process and avoid unequal groups if the study fails to meet enrollment targets. Forty (40) envelopes will be numbered 1 to 40 on the outside and the corresponding random allocation will be written on a card sealed inside the envelope. As soon as possible after the participant signs the consent form, the trial manager will select and open the next envelope in order. The participant’s group allocation will be recorded next to their study number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Key feasibility endpoints are recruitment rates and the participation and completion of the study interventions (from Exercise Logbook data) within the stated study periods. Primary outcomes are binary and will be reported as percentages with associated 95% confidence intervals.

Both an interim and end-of-study analysis of safety data will be undertaken. Analysis of safety data will include categorization by event type (pre-specified, emerging/unexpected), frequency counts, time to event including exercise sessions completed before event onset.

Secondary outcome measure endpoints will include changes in reported fatigue and QOL as measured respectively by the BFI and PROMIS-29v2.0 scores at baseline (week 0), compared with at 4?weeks (mid-point), 8?weeks (final week) and 9?weeks (1?week follow-up). Participant’s CEQ ratings are compared prior to study group randomization with their credibility scores on completing the Baduanjin MBE program.

Analyses of the endpoints will follow the Intent-to-Treat (all participants as per randomization), and per-protocol (participants adhering to the protocol). These analyses will include, as appropriate, participant demographic (co-variates) and Baduanjin MBE participatory frequency data. The secondary outcome data includes testing the analysis methods and assumptions of normality in the data with the full expectation these will be non-significant. Histograms and descriptive statistics will be used to investigate the distributions of these numeric measures. Departures from normality will be addressed using transformations (for skewness) or trimming or Winsorizing (for unresolvable outliers). Comparison between treatment and waitlist groups will be pilot tested using independent samples t-tests, repeated measures ANOVA and/or linear mixed models.

Missed weekly training sessions will not construe a protocol deviation and may be imputed from previous data entries. Pilot tests of possible regression based and/or multiple imputation techniques will be undertaken. This includes using these data to formulate future trial hypotheses.

All data will be entered and managed using the Research Electronic Data Capture (REDCap) management system and all analyses performed using SPSS (V 24.0; IBM Corp; Armonk, NY, USA) or descriptive analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
25/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
29
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23901 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 39385 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 313095 0
University
Name [1] 313095 0
Western Sydney University
Country [1] 313095 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country
Australia
Secondary sponsor category [1] 314801 0
None
Name [1] 314801 0
Address [1] 314801 0
Country [1] 314801 0
Other collaborator category [1] 282535 0
Government body
Name [1] 282535 0
South Western Sydney Local Health District
Address [1] 282535 0
South Western Sydney Local Health District Executive Office, Locked Bag 7279, Liverpool BC 1871
Country [1] 282535 0
Australia
Other collaborator category [2] 282536 0
University
Name [2] 282536 0
Beijing University of Chinese Medicine
Address [2] 282536 0
11 N 3rd Ring E Rd, Chaoyang, China, 100013
Country [2] 282536 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312340 0
South Western Sydney Local Health District (SWSLHD) Human Research Ethics Committee
Ethics committee address [1] 312340 0
Ethics committee country [1] 312340 0
Australia
Date submitted for ethics approval [1] 312340 0
05/12/2022
Approval date [1] 312340 0
22/12/2022
Ethics approval number [1] 312340 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124314 0
Prof Xiaoshu Zhu
Address 124314 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 124314 0
Australia
Phone 124314 0
+610246203338
Fax 124314 0
Email 124314 0
x.zhu@westernsydney.edu.au
Contact person for public queries
Name 124315 0
Julia Xiao
Address 124315 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 124315 0
Australia
Phone 124315 0
+61 0458 135 714
Fax 124315 0
Email 124315 0
Julia.Xiao@westernsydney.edu.au
Contact person for scientific queries
Name 124316 0
Sean Walsh
Address 124316 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 124316 0
Australia
Phone 124316 0
+61 476879662
Fax 124316 0
Email 124316 0
sean.walsh@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBaduanjin Mind-Body Exercise for Cancer-Related Fatigue: Protocol for a Remotely Delivered Randomized Wait-List Controlled Feasibility Study.2024https://dx.doi.org/10.1177/15347354231226127
N.B. These documents automatically identified may not have been verified by the study sponsor.