Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001115921
Ethics application status
Approved
Date submitted
21/08/2020
Date registered
28/10/2020
Date last updated
11/01/2023
Date data sharing statement initially provided
28/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A proof of concept randomised comparative study to investigate the effect of an online yoga intervention on mental health in women diagnosed with breast or gynaecological cancer,
Scientific title
A proof of concept randomised comparative study to investigate the effect of an online yoga intervention on mental health in women diagnosed with breast or gynaecological cancer,
Secondary ID [1] 301471 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 317792 0
anxiety 317793 0
cancer 317794 0
Condition category
Condition code
Cancer 315856 315856 0 0
Cervical (cervix)
Mental Health 317204 317204 0 0
Anxiety
Cancer 317205 317205 0 0
Breast
Cancer 317206 317206 0 0
Womb (Uterine or endometrial cancer)
Mental Health 317207 317207 0 0
Depression
Cancer 317208 317208 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group yoga classes 60 minute weekly for 6 weeks. Held online via zoom by a certified yoga therapist/teacher with experience teaching people with cancer and mental health issues. Teacher and participants to use device with video, teacher will have access to large screen to visualise participants easily. Practices will be mostly standardised but there may be some individualisation according to the needs of each participant. Practices/techniques will be drawn from a Delphi study conducted by this same team. Attendance will be recorded by the student who will be an observer at the classes for safety purposes. A weekly survey will also be completed by participants to record their adherence to classes and additional practice.
Intervention code [1] 317784 0
Lifestyle
Comparator / control treatment
Individual yoga sessions 60 minute weekly for 6 weeks. Held online via zoom by a certified yoga therapist/teacher with experience teaching people with cancer and mental health issues. Teacher and participants to use device with video, teacher will have access to large screen to visualise participants easily. Practices will be individualised to each participant. Practices/techniques will be drawn from a Delphi study conducted by this same team. Attendance will be recorded by the teacher as well as a weekly survey will also be completed by participants to record their adherence to classes and additional practice.
Control group
Active

Outcomes
Primary outcome [1] 324066 0
Anxiety and depression via Hospital Anxiety and Depression Scale (composite primary outcome)
Timepoint [1] 324066 0
6 weeks post-intervention
Primary outcome [2] 324067 0
Feasibility. Assessed by:
• The study participation rate (proportion of people accepting participation in the study)
• The degree of adherence to the program (proportion of attendance to sessions)
• Attrition (drop-out and withdrawal)
Study deemed feasible if: at least 50% of the eligible patients consent to participate, at least 60% of the patients attend half of the yoga sessions, and 60% of patients complete at least one follow-up time point.
This will be calculated by extracting the number of participants who complete the screening, consent to participate, attend the yoga sessions and complete follow up and will be calculated as a percentage of the totals.
Timepoint [2] 324067 0
6 weeks post-intervention
Secondary outcome [1] 383655 0
Depression, Anxiety and Stress Scale - 21: DASS-21 (composite outcome)
Timepoint [1] 383655 0
6 weeks post-intervention
Secondary outcome [2] 383656 0
Perceived Stress Scale
Timepoint [2] 383656 0
6 weeks post-intervention
Secondary outcome [3] 383657 0
Cancer Worry Scale
Timepoint [3] 383657 0
6 weeks post-intervention
Secondary outcome [4] 383658 0
Quality of life: European Organization for Research and Treatment of Cancer QLQ-C30
Timepoint [4] 383658 0
6 weeks post-intervention
Secondary outcome [5] 383659 0
Physical and mental health: PROMIS-10. This is one composite survey that measures aspects of physical function, fatigue, pain, emotional distress, and social health.
Timepoint [5] 383659 0
6 weeks post-intervention
Secondary outcome [6] 383660 0
EORTC fatigue scale
Timepoint [6] 383660 0
6 weeks post-intervention
Secondary outcome [7] 383661 0
Acceptability: self-report questions regarding participant perceptions of, and experiences with, the study and their respective programs. Study-specific questionnaire eg:
1) Was the objective of the yoga programme clear? Strongly disagree Disagree Agree Strongly agree
2) Did you easily understand the programme?
3) Did you easily understand the tips in the yoga exercises?
4) Was it easy to incorporate the yoga practice in your daily life?
5) Were you interested in this programme?
6) Was this programme useful for your daily life?
7) Were you satisfied with this programme?
8) Do you wish to continue the yoga programme?
Timepoint [7] 383661 0
6 weeks post-intervention

Eligibility
Key inclusion criteria
1. Aged 18 or older
2. Ability to speak and understand English
3. Meet diagnostic criteria for an affective disorder
4. HADS scores demonstrating at least mild severity of depression or anxiety (i.e. depression or anxiety score above 7)
5. Have been diagnosed with breast/gynaecological of cancer within the last 5 years
6. Medication (including herbal medications, such as St John’s wort) and professional mental health assistance being unchanged for 3 months
7. Have adequate general health to be involved in the yoga program
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Completed chemotherapy/radiotherapy (stable hormone therapy, targeted therapy or immunotherapy allowed)
2. Not taking corticosteroids
3. Serious injury or physical ailment (which yoga may negatively exacerbate), medical or psychological disorder likely to preclude completion of the trial
4. Have been undertaking yoga classes or a personal yoga practice, an average of more than once a week, over the past 3 months

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
recruitment stopped prior to sample size being reached due to it being a feasibility study and having enough participants to report on, and needing to complete PhD project
Date of first participant enrolment
Anticipated
1/11/2020
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
5/11/2021
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305909 0
University
Name [1] 305909 0
Western Sydney University
Country [1] 305909 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute
Address
158-160 Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 306363 0
None
Name [1] 306363 0
none
Address [1] 306363 0
none
Country [1] 306363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306161 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 306161 0
Ethics committee country [1] 306161 0
Australia
Date submitted for ethics approval [1] 306161 0
29/02/2020
Approval date [1] 306161 0
13/08/2020
Ethics approval number [1] 306161 0

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

Contacts
Principal investigator
Name 102922 0
Prof Jerome Sarris
Address 102922 0
NICM Health Research Institute. 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 102922 0
Australia
Phone 102922 0
+61 2 9685 4700
Fax 102922 0
Email 102922 0
[email protected]
Contact person for public queries
Name 102923 0
Maria Gonzalez
Address 102923 0
NICM Health Research Institute. 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 102923 0
Australia
Phone 102923 0
+61 2 9685 4700
Fax 102923 0
Email 102923 0
[email protected]
Contact person for scientific queries
Name 102924 0
Maria Gonzalez
Address 102924 0
NICM Health Research Institute. 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 102924 0
Australia
Phone 102924 0
+61 2 9685 4700
Fax 102924 0
Email 102924 0
[email protected]

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?

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.