Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Can Guolin Qigong (mind-body exercise) intervention improve fatigue in cancer survivors? A randomized controlled feasibility trial
Query!
Secondary ID [1]
306995
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lung cancer
326113
0
Query!
Fatigue
326136
0
Query!
Sleep
326137
0
Query!
Depression
326138
0
Query!
Breast cancer
326215
0
Query!
Colon cancer
326216
0
Query!
Condition category
Condition code
Cancer
323431
323431
0
0
Query!
Breast
Query!
Cancer
323432
323432
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
323433
323433
0
0
Query!
Lung - Non small cell
Query!
Cancer
323434
323434
0
0
Query!
Lung - Small cell
Query!
Cancer
323435
323435
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Mental Health
323436
323436
0
0
Query!
Depression
Query!
Mental Health
323437
323437
0
0
Query!
Other mental health disorders
Query!
Alternative and Complementary Medicine
323455
323455
0
0
Query!
Other alternative and complementary medicine
Query!
Physical Medicine / Rehabilitation
323456
323456
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
323440
0
Rehabilitation
Query!
Intervention code [2]
323462
0
Behaviour
Query!
Intervention code [3]
323463
0
Lifestyle
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
331167
0
Query!
Timepoint [1]
331167
0
End of Week-12 intervention.
Query!
Secondary outcome [1]
409081
0
Change in Fatigue to be assessed by Brief Fatigue Inventory (BFI)
Query!
Assessment method [1]
409081
0
Query!
Timepoint [1]
409081
0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks after post intervention (Week-16).
Query!
Secondary outcome [2]
409082
0
Change in Sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Query!
Assessment method [2]
409082
0
Query!
Timepoint [2]
409082
0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks after post intervention (Week-16).
Query!
Secondary outcome [3]
409083
0
Change in Depression to be assessed by Centre for Epidemiologic Studies Depression (CES-D)
Query!
Assessment method [3]
409083
0
Query!
Timepoint [3]
409083
0
Baseline(Week 1),mid-intervention (week-6), post-intervention (Week-12), and 4 weeks post intervention (Week-16).
Query!
Secondary outcome [4]
409084
0
Change in 24-hour urine cortisol
Query!
Assessment method [4]
409084
0
Query!
Timepoint [4]
409084
0
A day prior to enrolment date/baseline (Week1) and post-intervention (Week-12)
Query!
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.
Query!
Assessment method [5]
409150
0
Query!
Timepoint [5]
409150
0
Within 3 months after Week-16 (4 weeks post-intervention).
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/07/2022
Query!
Actual
22/10/2022
Query!
Date of last participant enrolment
Anticipated
31/12/2023
Query!
Actual
9/09/2023
Query!
Date of last data collection
Anticipated
30/06/2024
Query!
Actual
24/01/2024
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
40
Query!
Recruitment outside Australia
Country [1]
24735
0
Malaysia
Query!
State/province [1]
24735
0
Kuala Lumpur and Selangor
Query!
Funding & Sponsors
Funding source category [1]
311306
0
University
Query!
Name [1]
311306
0
Western Sydney University
Query!
Address [1]
311306
0
School of Health Science,
Western Sydney University,
Locked Bag 1797 Penrith NSW 2751 Australia
Query!
Country [1]
311306
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University Malaya Medical Centre
Query!
Address
Lembah Pantai,59100
Kuala Lumpur,
Malaysia
Query!
Country
Malaysia
Query!
Secondary sponsor category [1]
312671
0
University
Query!
Name [1]
312671
0
Western Sydney University
Query!
Address [1]
312671
0
School of Health Science,
Western Sydney University,
Locked Bag 1797 Penrith NSW 2751
Australia
Query!
Country [1]
312671
0
Australia
Query!
Secondary sponsor category [2]
312691
0
Individual
Query!
Name [2]
312691
0
Professor Gwo Fuang Ho
Query!
Address [2]
312691
0
Clinical Oncology Department
University Malaya Medical Centre
Lembah Pantai 59100
Kuala Lumpur
Malaysia
Query!
Country [2]
312691
0
Malaysia
Query!
Secondary sponsor category [3]
312692
0
Individual
Query!
Name [3]
312692
0
Professor Xiaoshu Zhu
Query!
Address [3]
312692
0
School of Health Science
Western Sydney University
Locked Bag 1797 Penrith NSW 2751
Australia
Query!
Country [3]
312692
0
Australia
Query!
Secondary sponsor category [4]
312693
0
Individual
Query!
Name [4]
312693
0
Associate Professor Eng Siew Koh
Query!
Address [4]
312693
0
South Western Sydney Clinical School,
Faculty of Medicine
University of New South Wales
Sydney NSW 2052
Australia
Query!
Country [4]
312693
0
Australia
Query!
Secondary sponsor category [5]
312694
0
Individual
Query!
Name [5]
312694
0
Dr Liu Bing Kai
Query!
Address [5]
312694
0
Centre Intégré de Médecine Chinoise,
Hôpital Universitaire la Pitié-Salpêtrière, 47-83,boulevard de l'hôpital, 75013 Paris, France
Query!
Country [5]
312694
0
France
Query!
Secondary sponsor category [6]
312695
0
Individual
Query!
Name [6]
312695
0
Professor Yutong Fei
Query!
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
Query!
Country [6]
312695
0
China
Query!
Secondary sponsor category [7]
312696
0
Individual
Query!
Name [7]
312696
0
Leng Keng (Sara) Low
Query!
Address [7]
312696
0
School of Health Science
Western Sydney University
Lock Bag 1797
Penrith NSW 2751
Query!
Country [7]
312696
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
310809
0
UMMC Medical Research Ethics Committee
Query!
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.
Query!
Ethics committee country [1]
310809
0
Malaysia
Query!
Date submitted for ethics approval [1]
310809
0
06/04/2022
Query!
Approval date [1]
310809
0
15/06/2022
Query!
Ethics approval number [1]
310809
0
MREC ID NO: 2022323-11092
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
118942
0
Prof Gwo Fuang Ho
Query!
Address
118942
0
Clinical Oncology Department
University of Malaya Medical Centre,
Lembah Pantai, 59100
Kuala Lumpur, Malaysia.
Query!
Country
118942
0
Malaysia
Query!
Phone
118942
0
+60379492120
Query!
Fax
118942
0
Query!
Email
118942
0
[email protected]
Query!
Contact person for public queries
Name
118943
0
Mrs Leng Keng (Sara) Low
Query!
Address
118943
0
School of Health Science
Western Sydney University
Lock Bag 1797 Penrith NSW 2751
Query!
Country
118943
0
Australia
Query!
Phone
118943
0
+60124206069
Query!
Fax
118943
0
Query!
Email
118943
0
[email protected]
Query!
Contact person for scientific queries
Name
118944
0
Mrs Leng Keng (Sara) Low
Query!
Address
118944
0
School of Health Science
Western Sydney University
Lock Bag 1797 Penrith NSW 2751
Query!
Country
118944
0
Australia
Query!
Phone
118944
0
+60124206069
Query!
Fax
118944
0
Query!
Email
118944
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
To retain the confidentiality of the participant's identity.
Query!
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.
Download to PDF