Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001670268
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
10/10/2018
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Date results information initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of Qigong (body-mind exercise) for insomnia in cancer survivors
Scientific title
Can Qigong (body-mind exercise) improve symptoms of insomnia in cancer survivors: a
feasibility study
Secondary ID [1] 296164 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia in cancer survivors 309783 0
Condition category
Condition code
Mental Health 308576 308576 0 0
Other mental health disorders
Cancer 308759 308759 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve a group of 15 participants who meet the inclusion and exclusion criteria and provide written consent. They will be taking part in a three weeks Qigong (mind body exercise).
The three weeks Qigong program consists of one hour face to face group practice session two times a week and three times a week online group practice via Zoom or Skype. During online practice, the instructor will practice online with the group to monitor the practice and progress. The Qigong practice will be made up of slow moving gentle exercise in standing and sitting position and conducted by the researcher who has more than 15 years experience in Qigong.
Participants will be required to record their practice in a diary and complete Insomnia Severity Index and Pittsburgh Sleep Quality Index at various data collection points to monitor their practices.
Intervention will be conducted at Western Sydney University campus.
Intervention code [1] 312491 0
Lifestyle
Intervention code [2] 312492 0
Behaviour
Intervention code [3] 312493 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307537 0
Feasibility of Qigong intervention as composite primary outcome assessed by recruitment, retention, adherence rate and adverse events (for safety) if any, using weekly diary.
However we do not foresee any adverse events based on past studies of Qigong intervention conducted to improve symptoms or side effects of cancer and cancer treatment for cancer survivors.
Timepoint [1] 307537 0
End of Week 3 of intervention
Secondary outcome [1] 352251 0
Change in sleep severity assessed by Insomnia Severity Index
Timepoint [1] 352251 0
Time point : Baseline and end of Week2, Week 3 and Week4(one week post intervention).
Secondary outcome [2] 352278 0
Change in sleep quality assessed by Pittsburgh Sleep Quality Index
Timepoint [2] 352278 0
Time point : Baseline, Week2, Week3 and Week 4

Eligibility
Key inclusion criteria
1) Age 18 years old;
2) Diagnosed with cancer or completed primary cancer treatment (chemotherapy and/or
radiotherapy) and/or at least 8 weeks post-surgery ;
3) Meet the criteria for insomnia as indicated by the score of Insomnia Severity Index (ISI)
11;
4) Not involved in any mind body therapy during the study period;
5) Patients who use stimulant medications, or other anxiolytic/sedative/hypnotic drugs
may be included to evaluate if there will be any change in the quantity of medication pre
and post intervention;
6) English language sufficient to understand study procedures an 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) No prior experience with Qigong, Yoga, Tai Chi or meditation within the past 3 months;
2) Body mass index > 35kg/m2;
3) Diagnosis of major depression and/or clinically significant depressive or anxiety
symptoms;
4) Sleep disturbance due to clear physical cause, e.g., benign prostatic hyperplasia,
frequent night-time urination, pain;
5) Neurological degenerative disease (e.g. dementia), reduced cognitive capacity in any way
that would affect ability to understand trial procedures and give informed consent;
6) Any other medical conditions which would preclude study intervention or make study
participation unsafe such as severe chronic heart failure, stroke sequelae

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study is to explore the feasibility and potential benefits of Qigong for insomnia in cancer survivors. As there is no prior information to base sample size, a prospective sample size calculation was not performed. Sample size of 12 per group is recommended for a pilot study. Assuming a dropout rate of 20%, we expect to recruit 15 participants for this study.
Descriptive statistics will be conducted with SPSS to describe and analyse data on feasibility and changes of sleep over multiple collection points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2018
Actual
12/02/2019
Date of last participant enrolment
Anticipated
24/01/2019
Actual
9/04/2019
Date of last data collection
Anticipated
22/02/2019
Actual
6/05/2019
Sample size
Target
15
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300756 0
University
Name [1] 300756 0
Western Sydney University
Country [1] 300756 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 300292 0
Individual
Name [1] 300292 0
Asso Prof Xiaoshu Zhu
Address [1] 300292 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, AUSTRALIA
Country [1] 300292 0
Australia
Secondary sponsor category [2] 300296 0
Individual
Name [2] 300296 0
Dr Bobby Cheema
Address [2] 300296 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, Australia
Country [2] 300296 0
Australia
Secondary sponsor category [3] 300297 0
Individual
Name [3] 300297 0
Dr Amy Tan
Address [3] 300297 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, Australia
Country [3] 300297 0
Australia
Secondary sponsor category [4] 300437 0
Individual
Name [4] 300437 0
Low leng Keng
Address [4] 300437 0
c/o Asso Prof Xiaoshu Zhu
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751 Australia
Country [4] 300437 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301536 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 301536 0
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, Australia
Ethics committee country [1] 301536 0
Australia
Date submitted for ethics approval [1] 301536 0
Approval date [1] 301536 0
04/09/2018
Ethics approval number [1] 301536 0
H12870

Summary
Brief summary
The purpose of this study is to examine the feasibility of body-mind exercises (called ‘Qigong’) for cancer survivors.

Who is it for?
You may be eligible for this study if you are aged 18 or over, completed anticancer treatment at least 3 months ago and meet a criteria for insomnia.

Study details
All participants will partake in a three week group program, involving two face-to-face sessions and three online sessions. The program will involve slow-moving gentle exercise in a standing or sitting position. Participants will complete a diary and answer some questionnaires throughout the three week program and for a week after the program

It is hoped this research will provide some evidence of the feasibility and potential benefits of Qigong for insomnia in this patient group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87318 0
Mrs Leng Keng (Sara) Low
Address 87318 0
c/o Asso Prof Xiaoshu Zhu
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, AUSTRALIA
Country 87318 0
Australia
Phone 87318 0
+61 2 4620 3338
Fax 87318 0
+61 2 4620 3292
Email 87318 0
[email protected]
Contact person for public queries
Name 87319 0
A/Prof Xiaoshu Zhu
Address 87319 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, AUSTRALIA
Country 87319 0
Australia
Phone 87319 0
+61 2 4620 3338
Fax 87319 0
+61 2 4620 3292
Email 87319 0
[email protected]
Contact person for scientific queries
Name 87320 0
A/Prof Xiaoshu Zhu
Address 87320 0
School of Science and Health
Western Sydney University
Locked Bag 1797, Penrith NSW 2751, AUSTRALIA
Country 87320 0
Australia
Phone 87320 0
+61 2 4620 3338
Fax 87320 0
+61 2 4620 3292
Email 87320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researcher involved in the study, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Descriptive analysis, one way repeated measures analysis (ANOVA) and thematic qualitative data analysis only to achieve the aims in the approved proposal
How or where can data be obtained?
De-identified data will only be shared if the study is published. Data is kept in locked cabinet in a room at Western Sydney University Campbelltown campus, Locked Bag 1797 Penrith NSW 2751 Australia, accesible only by security swipe by authorised personnel. Access to participants data is restricted to the principal investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 1. Research question: Can Qigong (body mind ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Feasibility and Effects of Qigong Intervention (Mind-Body Exercise) in Cancer Patients With Insomnia: A Pilot Qualitative Study.2020https://dx.doi.org/10.1177/1534735420977671
N.B. These documents automatically identified may not have been verified by the study sponsor.