Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000397819
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
9/04/2021
Date last updated
20/10/2022
Date data sharing statement initially provided
9/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An online yoga sequence for Breast Cancer-related Lymphoedema: a feasibility study
Scientific title
An online yoga sequence for Breast Cancer-related Lymphoedema: a feasibility study
Secondary ID [1] 303395 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema in breast cancer 320677 0
Condition category
Condition code
Cancer 318522 318522 0 0
Breast
Physical Medicine / Rehabilitation 318842 318842 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single-arm feasibility study. Women with breast cancer related lymphoedema will be invited to participate in a weekly online group class supported by a short pre-recorded yoga sequence to support home practice. Participants will attend 12 weekly 60-minute yoga sessions conducted online via Zoom. The 12 sessions will comprise one-on-one individual session in the first week followed by eleven group sessions. An additional shorter home version using pre-recorded sequence will be provided to be undertaken on a daily basis. Adherence will be checked by Zoom attendance checklists. The 15-minute home practice and compliance will be assessed using weekly logs completed by participants as part of study. The class will be teacher-led and follow a similar specialised sequence of postures (asanas) used in a previous study of women with breast cancer related lymphoedema. All yoga classes and individual sessions will be conducted by a suitably qualified yoga teacher. Suitable qualifications of yoga teachers includes registration and minimum level 2 membership with Yoga Australia (the peak professional body for the yoga teaching profession in Australia). This equates to a minimum of 500 yoga teacher training hours over 2 years, and a minimum of 2 years teaching experience. Yoga classes will be kept small, with a maximum of 6 participants in each class to allow for individualised attention.
Intervention code [1] 319701 0
Lifestyle
Intervention code [2] 319943 0
Rehabilitation
Comparator / control treatment
No control group (single arm)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326479 0
Feasibility using the Feasibility of Intervention Measure
Timepoint [1] 326479 0
12 weeks (upon intervention completion)
Primary outcome [2] 326480 0
Acceptability using the Acceptability of Intervention Measure
Timepoint [2] 326480 0
12 weeks (upon intervention completion)
Primary outcome [3] 326481 0
Appropriateness using the of Appropriateness of Intervention Measure
Timepoint [3] 326481 0
12 weeks (upon intervention completion)
Secondary outcome [1] 391635 0
Extracellular fluid volume measured using bioimpedence spectroscopy
Timepoint [1] 391635 0
Baseline, 12 weeks (upon intervention completion)
Secondary outcome [2] 391636 0
Arm volume measured using Relative Arm Volume Increase
Timepoint [2] 391636 0
Baseline, 12 weeks (upon intervention completion)
Secondary outcome [3] 391637 0
Range of Movement measured using inclinometer
Timepoint [3] 391637 0
Baseline, 12 weeks (upon intervention completion)
Secondary outcome [4] 391638 0
coping and self-efficacy assessed using the Cancer Behaviour Inventory
Timepoint [4] 391638 0
Baseline, 12 weeks (upon intervention completion)
Secondary outcome [5] 391639 0
quality of life assessed using the EORTC Quality of Life Questionnaire
Timepoint [5] 391639 0
Baseline, 12 weeks (upon intervention completion)

Eligibility
Key inclusion criteria
1. Female
2. Aged 18 and over
3. Breast cancer diagnosis
4. Completed chemotherapy and radiotherapy
5. Diagnosed with breast cancer related lymphoedema
6. Be able to complete the questionnaires in English
7. Have access to ZOOM
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary Lymphoedema
- Recurrent cancer
- Infection or cellulitis
- Pregnancy (contraindicated for bioimpedance outcome measure)
- Taking on new physical activity during study period
- Current practicing regular yoga (minimum 1x per week)
- Active treatment (e.g. bandaging programs) within 3 months of commencing the study (regular ongoing management, e.g. compression garment, regular massage, at home pump use, is acceptable)

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2021
Actual
11/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307813 0
Hospital
Name [1] 307813 0
Chris O'Brien Lifehouse
Country [1] 307813 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 308518 0
University
Name [1] 308518 0
Western Sydney University
Address [1] 308518 0
Locked Bag 1797 Penrith NSW 2751
Country [1] 308518 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307819 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 307819 0
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 307819 0
Australia
Date submitted for ethics approval [1] 307819 0
Approval date [1] 307819 0
30/10/2020
Ethics approval number [1] 307819 0

Summary
Brief summary
This trial aims to determine feasibility and preliminary efficacy of a 12-week online yoga program in women with breast cancer-related lymphoedema, and to evaluate its impact on coping skills and quality of life.

Who is it for?
You may be eligible for this study if you are 18 or above, have completed chemotherapy or radiotherapy for breast cancer, and have breast cancer-related lymphoedema.

Study details
Participants will attend one 60-minute yoga session per week via Zoom. The first session will be one-on-one, followed by 11 group sessions with a maximum of 6 participants. Participants will also be given pre-recorded sequences that can be practised for 15 minutes every day of the 12-week program. A number of questionnaires will be given for completion before and after the 12-week program, as well as arm measurements and range of motion tests to assess for improvements in lymphoedema symptoms.

It is hoped that this study may demonstrate that yoga classes delivered online can improve arm volume (circumference), range of motion, self-efficacy, coping and quality of life in individuals with breast cancer-related lymphoedema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108610 0
Dr Suzanne Grant
Address 108610 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108610 0
Australia
Phone 108610 0
+61 419126209
Fax 108610 0
Email 108610 0
[email protected]
Contact person for public queries
Name 108611 0
Dr Suzanne Grant
Address 108611 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108611 0
Australia
Phone 108611 0
+61 02 8514 0000
Fax 108611 0
Email 108611 0
[email protected]
Contact person for scientific queries
Name 108612 0
Dr Suzanne Grant
Address 108612 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 108612 0
Australia
Phone 108612 0
+61 02 8514 0000
Fax 108612 0
Email 108612 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.