Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000743965
Ethics application status
Approved
Date submitted
20/04/2020
Date registered
16/07/2020
Date last updated
24/03/2024
Date data sharing statement initially provided
16/07/2020
Date results information initially provided
24/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Behaviour Change for Physical Activity after Metastatic Breast Cancer
Scientific title
Application of a behaviour change intervention to increase physical activity in women with metastatic breast cancer: pilot randomised controlled trial.
Secondary ID [1] 300982 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 317017 0
Condition category
Condition code
Cancer 315184 315184 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive behavioural counselling to increase their physical activity. This will occur over 12 weeks: weekly for the first 6 weeks, then fortnightly for the later 6 weeks, for a total of 10 sessions (inclusive of the first and last week).

Sessions will consist of discussing personal goals, barriers, enablers, pros and cons of physical activity and cognitive and behavioural strategies to aid in the process. Topics of discussion will be guided by the Transtheoretical Model of Behaviour Change. They will also receive an informational handbook designed specifically for this study, a physical activity diary and a Fitbit device.

The initial and final sessions will be conducted in person at the university campus and is expected to take between 1.5 to 2 hours, including assessments. The rest of the sessions will take place via a range of modes, depending on the preference the participant (e.g. telephone, online video chat) and are expected to last between 15 to 30 minutes. The topics covered in these sessions will be tailored according to each participants' context (e.g. stage of change, support needs and barriers).

Measures of study feasibility and safety will be taken, including recruitment rates, session completion, reasons for non-compliance/withdrawal and adverse events.

The intervention will be delivered by a doctoral student, under the guidance of an experienced supervisory team.
Intervention code [1] 317306 0
Behaviour
Comparator / control treatment
This study will use an attention control group. The control group will receive a general physical activity recommendation and the same informational handbook as the intervention group but modified to not include behaviour change theories or strategies. They will also receive the same physical activity diary and Fitbit device.

To attain the same level of contact, participants in the control group will be contacted at the same frequency (weekly for the first 6 weeks, then fortnightly for the later 6 weeks) to repeatedly administer a symptom questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 323440 0
International Physical Activity Questionnaire - Short Form
Timepoint [1] 323440 0
12 and 18 weeks post commencement of the intervention
Primary outcome [2] 323441 0
Actigraph Accelerometer 5-day wear
Timepoint [2] 323441 0
12 weeks post commencement of the intervention
Secondary outcome [1] 381953 0
Behaviour change variables (i.e. self-efficacy, decisional balance and processes of change) measured using the Transtheoretical Model Behaviour Change Questionnaire
Timepoint [1] 381953 0
12 and 18 weeks post commencement of the intervention
Secondary outcome [2] 381954 0
Predicted VO2max estimated using a modified YMCA submaximal recumbent cycle ergometer aerobic fitness test
Timepoint [2] 381954 0
12 weeks post commencement of the intervention
Secondary outcome [3] 381955 0
Predicted lower limb maximal strength estimated using a leg press submaximal test
Timepoint [3] 381955 0
12 weeks post commencement of the intervention
Secondary outcome [4] 381956 0
General physical function measured using the 6-minute Walk Test
Timepoint [4] 381956 0
12 weeks post commencement of the intervention
Secondary outcome [5] 381957 0
Lower limb physical function measured using the 30-second Chair Stand Test
Timepoint [5] 381957 0
12 weeks post commencement of the intervention
Secondary outcome [6] 381958 0
EORTC Quality of Life Questionnaires C30 and FA12
Timepoint [6] 381958 0
12 and 18 weeks post commencement of the intervention
Secondary outcome [7] 381959 0
Social Support for Exercise Questionnaire
Timepoint [7] 381959 0
12 and 18 weeks post commencement of the intervention
Secondary outcome [8] 383084 0
Study safety and feasibility measured by recording adherence and adverse events.
Timepoint [8] 383084 0
12 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
- Women diagnosed with metastatic breast cancer
- ECOG Grade 0-2 (ambulatory and capable of self-care)
- English speaking
- Life expectancy of the study duration (12-weeks plus 3 month-follow up)
- Not currently physically active for more than 150 minutes/week at moderate intensity
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to attend campus for the physical assessments. Muscuoloskeletal or neurological impairments that would preclude them from undertaking a walking program.

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)
Allocation to group will not be known until after baseline data are completed. The allocation will be in sealed opaque envelopes that are number on the outside of the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence order using a randomisation table created by random number generator in Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics only will be undertaken to provide preliminary data to inform a larger trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
2/05/2022
Date of last participant enrolment
Anticipated
30/04/2021
Actual
28/04/2023
Date of last data collection
Anticipated
30/09/2021
Actual
31/08/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305430 0
University
Name [1] 305430 0
The University of Sydney
Country [1] 305430 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
75 East St Lidcombe, 2141 NSW
Country
Australia
Secondary sponsor category [1] 305822 0
None
Name [1] 305822 0
Address [1] 305822 0
Country [1] 305822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305749 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 305749 0
Level 3, Administration Building (F23), University of Sydney NSW 2006
Ethics committee country [1] 305749 0
Australia
Date submitted for ethics approval [1] 305749 0
20/04/2020
Approval date [1] 305749 0
22/06/2020
Ethics approval number [1] 305749 0
2020/310

Summary
Brief summary
The purpose of this study is to determine if a behaviour change intervention is effective in increasing physical activity in women with breast cancer.

Who is it for?

You may be eligible for this study if you are an adult female who has been diagnosed with metastatic breast cancer (i.e. spread to the bones or one of the organs) and currently not a regular exerciser.

Study details

Participants will be randomly divided into two groups. Both groups will receive a Fitbit device and activity diary booklet, and take part in 6 weekly and 3 fortnightly calls over 12 weeks total.
- For Group A, the phone calls will involve asking about their physical activity and cancer-related symptoms
- For Group B, the phone calls will additionally include counselling for physical activity based on behaviour change theories.

The majority of the project will be done over the phone or online, with the first and last sessions done in-person.

Participants will need to complete assessments at baseline and after 12 weeks at the University of Sydney, involving physical assessments looking at fitness and physical function, and answering questionnaires.

It is hoped that this research will help determine if a 12-week behaviour change program will result in changes in physical activity and quality of life for exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101458 0
Prof Sharon Kilbreath
Address 101458 0
Breast Cancer and Lymphedema Research Group, University of Sydney
75 East St Lidcombe, 2141 NSW
Country 101458 0
Australia
Phone 101458 0
+61 2 9351 9272
Fax 101458 0
Email 101458 0
[email protected]
Contact person for public queries
Name 101459 0
Mr Mark Liu
Address 101459 0
University of Sydney Faculty of Health Sciences PO Box 170 Lidcombe NSW 1825
Country 101459 0
Australia
Phone 101459 0
+61 2 9036 7309
Fax 101459 0
Email 101459 0
[email protected]
Contact person for scientific queries
Name 101460 0
Mr Mark Liu
Address 101460 0
University of Sydney Faculty of Health Sciences PO Box 170 Lidcombe NSW 1825
Country 101460 0
Australia
Phone 101460 0
+61 2 9036 7309
Fax 101460 0
Email 101460 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
THis is a small pilot study to obtain preliminary data regarding safety.


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.