Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000688785
Ethics application status
Approved
Date submitted
27/04/2022
Date registered
12/05/2022
Date last updated
25/06/2024
Date data sharing statement initially provided
12/05/2022
Date results information initially provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Guolin Qigong (mind-body exercise) intervention improve fatigue in cancer survivors? A randomized controlled feasibility trial
Scientific title
Can Guolin Qigong (mind-body exercise) intervention improve fatigue in cancer survivors? A randomized controlled feasibility trial
Secondary ID [1] 306995 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 326113 0
Fatigue 326136 0
Sleep 326137 0
Depression 326138 0
Breast cancer 326215 0
Colon cancer 326216 0
Condition category
Condition code
Cancer 323431 323431 0 0
Breast
Cancer 323432 323432 0 0
Lung - Mesothelioma
Cancer 323433 323433 0 0
Lung - Non small cell
Cancer 323434 323434 0 0
Lung - Small cell
Cancer 323435 323435 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Mental Health 323436 323436 0 0
Depression
Mental Health 323437 323437 0 0
Other mental health disorders
Alternative and Complementary Medicine 323455 323455 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 323456 323456 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomized controlled trial to evaluate the feasibility and effects of a 12-week Guolin Qigong (GQ) intervention (compared to usual care) on fatigue, depression, sleep quality and diurnal cortisol slope of 60 breast, lung and colorectal cancer survivors who meet the inclusion and exclusion criteria and provide written consent.
All outcomes will be assessed at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention) and Week-16 (4 weeks post- intervention).
At baseline (Week-1), participants will undergo a baseline assessment of questionnaires, and provide urinary samples (for 24-hour urinary cortisol test) a day prior to enrolment date to assess urinary cortisol and complete Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI) and Centre for Epidemiologic Studies Depression (CES-D). At mid-intervention (week-6) and 4 weeks after completion of intervention (Week-16) BFI, PSQI and CES-D will be collected. Post-intervention (week-12) data collection will include both the three patient reported outcomes and urinary cortisol outcome.
Adherence, attendance, and any adverse event will be recorded throughout the intervention period from Week-1 to Week-12 in the practice diary by the participants randomised to GQ group.
The GQ intervention will include 12 weeks of face-to-face (F2F) training class in the hospital with home practice on non-class days. There will be two F2F training classes/ week of two hours each for the first two weeks to intensify the opportunity to learn the practice well and once a week for the remaining period. The frequency of home practice will be three to four times a week over the 12-week intervention period with one and a half hours to 2 hours a day of training recommended to have efficacy. As GQ is an adaptive exercise and the main goal is for patients not to feel exhausted after practice, the home practice can be broken down into shorter sessions of 5 to 40 minutes to achieve cumulative effect.
The F2F GQ class will be taught by qualified GQ instructors with more than 5 years of experience in GQ training to ensure the full potential of the GQ intervention. The co-investigator who is a registered Chinese Medicine practitioner in Malaysia and Australia with more than 15 years in Qigong will be in attendance during the F2F GQ classes. The GQ protocol includes one-on-one first F2F session and group class for subsequent F2F sessions. The GQ training is a “walking qigong,” consisted of several breathing and moving exercises.
Intervention code [1] 323440 0
Rehabilitation
Intervention code [2] 323462 0
Behaviour
Intervention code [3] 323463 0
Lifestyle
Comparator / control treatment
For patients randomised to the usual care control group, at baseline (Week-1), patients will undergo a baseline assessment of questionnaires, and provide urinary samples (for urinary cortisol test) at three time points per day a day prior to enrolment date and complete BFI, PSQI, CES-D. At mid-intervention (week-6) and 4 weeks after completion of the intervention (Week-16), the three patient-reported outcome data will be collected. Post-intervention (week-12) data collection will include both the three patient-reported outcomes and urinary cortisol test outcomes.
The usual care control group is patients who have either the standard conventional medical treatment or no treatment and have not taken part in GQ before. Patients in the usual care control group can join the next cohort of the GQ intervention group when enough participants (at least 3 participants for the GQ intervention group) are recruited to start a new cohort if they so wish but no data will be collected.
Control group
Active

Outcomes
Primary outcome [1] 331167 0
Feasibility of GQ intervention as a composite primary outcome assessed by recruitment, retention, adherence rate and adverse events (for safety) if any, using a practice diary.
However, we do not anticipate any serious adverse events based on past studies of Qigong intervention conducted to improve cancer symptoms or side effects of cancer survivors.
Timepoint [1] 331167 0
End of Week-12 intervention.
Secondary outcome [1] 409081 0
Change in Fatigue to be assessed by Brief Fatigue Inventory (BFI)
Timepoint [1] 409081 0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks after post intervention (Week-16).
Secondary outcome [2] 409082 0
Change in Sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 409082 0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks after post intervention (Week-16).
Secondary outcome [3] 409083 0
Change in Depression to be assessed by Centre for Epidemiologic Studies Depression (CES-D)
Timepoint [3] 409083 0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks post intervention (Week-16).
Secondary outcome [4] 409084 0
Change in 24-hour urine cortisol
Timepoint [4] 409084 0
A day prior to enrolment date/baseline (Week1) and post-intervention (Week-12)
Secondary outcome [5] 409150 0
Participants' perceptions and experience of GQ.
A one-on-one semi-structured interview will be conducted using interview outlines designed specifically for this study.
Timepoint [5] 409150 0
Within 3 months after Week-16 (4 weeks post-intervention).

Eligibility
Key inclusion criteria
(1) Age equal to or greater than 18 years old); (2) Diagnosed with breast, lung, and colorectal cancer; (3) Able to read and answer questionnaires in English and Bahasa Malaysia language by oneself; (4) Suffering from moderate to severe fatigue as assessed by the simple fatigue scale with a severity score of 3 and above; (5) Able to use smartphones and the WeChat or WhatsApp app; and (6) Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Cardiopulmonary disease, nerve, muscle, or joint disease, or other malignant tumors affecting physical movement; (2) Mental illness or serious cognitive impairment and defects in language that significantly impairs communication; (3) Post-operative heart, cerebral vessel, or other physical impairment affecting the physical ability to participate in the study; (4) Patients who are not able to legally provide consent.

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)
After informed consent participants will be randomly assigned to either the Guolin Qigong or the usual care group at a 1:1 ratio in the order of date of visit with the random sequence generated by an online computerized randomisation system using the minimisation method. Randomisation will be conducted by an independent researcher, with sealed to conceal allocation till the occurrence of the assignment to avoid the influence of the investigator in the assignment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using minimisation method by computer software (i.e. computerised sequence generation)
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
While the CONSORT 2010 EXTENTION TO RANDOMISED PILOT AND FEASIBILTY TRIALS does not require a formal sample size calculation, when considering the provision of high precision parameter for formal trials, it is recommended that the sample size of each group is not less than 30 cases if the level of indicator variation in the expected population is large. Moreover, in the case of limited experimental resources, researchers need to consider seeking conditions that minimize the total sample size of pre-tests and formal trials which is closely related to the standard effect size of the intervention. It is recommended that the investigator estimate the effect size based on clinical experience. Smaller clinical effect sizes often require larger pre-test samples; conversely, the sample size is relatively small. In the case of medium standard effect size, usually continuous variables require 35 cases in each group while Whitehead et al suggests that the size of a pilot trial should be related to the size of the future definitive RCT. For such a trial designed with 90% power and two sided 5% significance, they recommend pilot trial sample sizes for each treatment arm of 75, 25, 15, and 10 for standardised effect sizes that are extra small (0.1), small (0.2), medium (0.5), or large (0.8), respectively. In relation to treatment fidelity of pilot trials, the sample size required for analysis given 90% power and one-sided 5% alpha of around n = 26-34 in intervention group alone will be significant indicating acceptable fidelity.
Taking into account the above recommendations and previous research on the effect of Qigong on fatigue in cancer patients reporting effect sizes ranging from 0.18 to 3.3 (Cohen`s d), a conservative sample size of 60 (30 in each group) will be used for this study based on small effect size with 90% power and two-sided 5% significance trial design.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2022
Actual
22/10/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
9/09/2023
Date of last data collection
Anticipated
30/06/2024
Actual
24/01/2024
Sample size
Target
60
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24735 0
Malaysia
State/province [1] 24735 0
Kuala Lumpur and Selangor

Funding & Sponsors
Funding source category [1] 311306 0
University
Name [1] 311306 0
Western Sydney University
Country [1] 311306 0
Australia
Primary sponsor type
University
Name
University Malaya Medical Centre
Address
Lembah Pantai,59100
Kuala Lumpur,
Malaysia
Country
Malaysia
Secondary sponsor category [1] 312671 0
University
Name [1] 312671 0
Western Sydney University
Address [1] 312671 0
School of Health Science,
Western Sydney University,
Locked Bag 1797 Penrith NSW 2751
Australia
Country [1] 312671 0
Australia
Secondary sponsor category [2] 312691 0
Individual
Name [2] 312691 0
Professor Gwo Fuang Ho
Address [2] 312691 0
Clinical Oncology Department
University Malaya Medical Centre
Lembah Pantai 59100
Kuala Lumpur
Malaysia
Country [2] 312691 0
Malaysia
Secondary sponsor category [3] 312692 0
Individual
Name [3] 312692 0
Professor Xiaoshu Zhu
Address [3] 312692 0
School of Health Science
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Australia
Country [3] 312692 0
Australia
Secondary sponsor category [4] 312693 0
Individual
Name [4] 312693 0
Associate Professor Eng Siew Koh
Address [4] 312693 0
South Western Sydney Clinical School,
Faculty of Medicine
University of New South Wales
Sydney NSW 2052
Australia
Country [4] 312693 0
Australia
Secondary sponsor category [5] 312694 0
Individual
Name [5] 312694 0
Dr Liu Bing Kai
Address [5] 312694 0
Centre Intégré de Médecine Chinoise,
Hôpital Universitaire la Pitié-Salpêtrière, 47-83,boulevard de l'hôpital, 75013 Paris, France
Country [5] 312694 0
France
Secondary sponsor category [6] 312695 0
Individual
Name [6] 312695 0
Professor Yutong Fei
Address [6] 312695 0
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine
School of Traditional Chinese Medicine, Beijing University of Chinese Medicine
11 Bei San Juan Dong Lu, Chao Yang District, Beijing, China 100029
Country [6] 312695 0
China
Secondary sponsor category [7] 312696 0
Individual
Name [7] 312696 0
Leng Keng (Sara) Low
Address [7] 312696 0
School of Health Science
Western Sydney University
Lock Bag 1797
Penrith NSW 2751
Country [7] 312696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310809 0
UMMC Medical Research Ethics Committee
Ethics committee address [1] 310809 0
UMMC-MREC Secretariat Office (Jawatankuasa Etika Penyelidikan Perubatan),
Level 2, Kompleks Pendidikan Sains Kejururawatan,
University of Malaya Medical Centre,
Lembah Pantai, 59100
Kuala Lumpur, Malaysia.
Ethics committee country [1] 310809 0
Malaysia
Date submitted for ethics approval [1] 310809 0
06/04/2022
Approval date [1] 310809 0
15/06/2022
Ethics approval number [1] 310809 0
MREC ID NO: 2022323-11092

Summary
Brief summary
This study aims to explore GQ for cancer care to inform future fully powered randomized controlled trial
Research objectives:
I. To conduct a 12-week randomized controlled trial of GQ with 60 breast, lung and colorectal cancer survivors to determine
a) if it is feasible to conduct home-based GQ and
b) whether GQ training is associated with changes in fatigue, depression, sleep, and cortisol level in cancer survivors?
II: To understand participants’ perceptions and experience of GQ through interview to identify: a) the benefits gained from participation in GQ intervention.
b) the barriers to GQ participation/adherence and recommendations for
improvement.
Other than the above, it is hoped that this study will improve the fatigue, sleep and depression of participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118942 0
Prof Gwo Fuang Ho
Address 118942 0
Clinical Oncology Department
University of Malaya Medical Centre,
Lembah Pantai, 59100
Kuala Lumpur, Malaysia.
Country 118942 0
Malaysia
Phone 118942 0
+60379492120
Fax 118942 0
Email 118942 0
gwoho@um.edu.my
Contact person for public queries
Name 118943 0
Mrs Leng Keng (Sara) Low
Address 118943 0
School of Health Science
Western Sydney University
Lock Bag 1797 Penrith NSW 2751
Country 118943 0
Australia
Phone 118943 0
+60124206069
Fax 118943 0
Email 118943 0
sara.low@westernsydney.edu.au
Contact person for scientific queries
Name 118944 0
Mrs Leng Keng (Sara) Low
Address 118944 0
School of Health Science
Western Sydney University
Lock Bag 1797 Penrith NSW 2751
Country 118944 0
Australia
Phone 118944 0
+60124206069
Fax 118944 0
Email 118944 0
sara.low@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
To retain the confidentiality of the participant's identity.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.