Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001168640
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
10/11/2023
Date last updated
5/06/2024
Date data sharing statement initially provided
10/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise intervention for adults undergoing treatment for breast cancer
Scientific title
The effect of exercise intervention on quality of life for adults undergoing treatment for breast cancer using a Self-determined, Monitored and Adaptable Rehabilitation with Telehealth support (SMART) exercise intervention.
Secondary ID [1] 310719 0
S01/2023
Universal Trial Number (UTN)
Trial acronym
SMART exercise intervention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 331659 0
Condition category
Condition code
Cancer 328380 328380 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve a state-of-the-art exercise program, with individual and periodized rehabilitation prescription, with adherence monitoring and regular one-on-one support to aid compliance. We refer to this as our “SMART” exercise intervention (Self-Determined, Monitored Adaptable Rehabilitation with Telehealth support). Individuals will be supported to build up or maintain a target exercise goal of 150 mins moderate intensity exercise per week (inclusive of 2 resistance sessions) as informed by guidelines from the American College of Sports Medicine for exercise and cancer. The intervention will run over a 16 week period.

The target behaviour of the SMART program is for participants to work towards or maintain 150 minutes per week of moderate intensity exercise (or 75 minutes per week of vigorous intensity exercise) including two resistance training sessions per week. Moderate intensity exercise will be defined as exercise performed at 60 to 75% of their age predicted maximum heart rate. Vigorous intensity exercise will be defined exercise performed at > 75% of their age predicted maximum heart rate. Resistance training session will encompass the major muscle groups and will be defined as completion of 3 sets of 8-12 repetitions of strength-based or functional tasks (for example, sit to stand, bicep curls, squats). The goal will be to report an intensity that is perceived a 15 (‘hard’) on the 6 to 20 Rating of Perceived Exertion. Intensity will be progressed by increasing the resistance and/or to a more challenging movement pattern. It has been mentioned that side effects relating to breast cancer (BC) treatments are expected to lead to deterioration in physical capacity, as well as associated side effects including but not limited to nausea, dizziness, arthralgia or bone pain. Resultantly, it is reasonable to expect that there will be some days/weeks where many participants will not be able to meet the above target guidelines. In addition to the target program, lower intensity options will also be prescribed to account for the expected fluctuation in treatment related side effects.

After initial recruitment, all study participants will complete an initial assessment to establish their baseline measures. The participants will be requested to complete the initial EORTC Quality of Life C30 questionnaire, as well as the breast cancer specific BR45 module. The trial physiotherapist will also assess participant muscle strength (grip strength, upper limb and lower limb muscle strength) and exercise tolerance (6-minute walking distance). Participant body composition will also be measured using the SOZO analyser. These outcomes are discussed in detail below.

After the randomisation, the SMART intervention group participants will attend an hour-long initial assessment session with a physiotherapist. During this appointment, the physiotherapist will provide education regarding the target exercise goal. Patients individual exercise preferences and existing exercise habits will be discussed and a treatment plan and goals will be made to work towards achieving or maintaining the target exercise dosage.

Online resources will be accessible by all participants in the SMART intervention group. These online resources will contain each individual with a personal login containing their target program, low intensity program, exercise logs, prompts to complete the program and to complete short questionnaires as required. The exercise programs will be available in written online form with short videos and/or photos specific to each individual. Flexibility in the program will be provided with exercises able to be completed either in participants own environment and/or during three weekly physiotherapy gym sessions at RPH.

The participants in the SMART intervention group will also be given weekly one-on-one telehealth calls (up to an hour duration) from a physiotherapist to supervise exercise sessions, provide behaviour change strategies to encourage regular exercise habits through their BC treatment and to problem solve during weeks of low adherence to help them get 'back on track'. During these weekly sessions, feedback from symptom monitoring questionnaires will be discussed and exercise programs will be progressed or tapered accordingly.
Intervention code [1] 327118 0
Rehabilitation
Comparator / control treatment
Usual care will involve education with a physiotherapist regarding the importance of exercise during cancer treatment according to the above-mentioned exercise target informed by the guidelines by the 2019 American College of Sports Medicine (ACSM) guidelines for exercise and cancer. This will be administered in a 30-minute, one-on-one session (face-to-face or telehealth delivery).

Participants will be provided with a pamphlet for appropriate off-site exercise groups such as Community Physiotherapy Services (CPS) exercise groups and/or Cancer Council Encore exercise groups.

In addition, a 30-minute follow-up by phone every 4 weeks will be provided by a physiotherapist to assess exercise using the International Physical Activity Questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 336221 0
EORTC C30 and BR45 quality of life questionnaires
Timepoint [1] 336221 0
The primary outcomes will be assessed at the following time points:
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
Primary outcome [2] 338450 0
Quality of Life
Timepoint [2] 338450 0
Primary outcome [3] 338451 0
Quality of Life
Timepoint [3] 338451 0
- Baseline
- Mid intervention (8 weeks following baseline)
- End of intervention (16 weeks following baseline)
- Long term assessment: (1 year following baseline)
Secondary outcome [1] 427399 0
Absenteeism from work
Timepoint [1] 427399 0
-Baseline
-Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)
Secondary outcome [2] 428016 0
Chemotherapy completion rates
Timepoint [2] 428016 0
End of chemotherapy treatment date
Secondary outcome [3] 435977 0
Health care utilisation measure.
Timepoint [3] 435977 0
Secondary outcome [4] 435978 0
Health care utilisation measure.
Timepoint [4] 435978 0
- Baseline
- Mid intervention (8 weeks following baseline)
-End of intervention (16 weeks following baseline)
-Long term assessment: (1 year following baseline)

Eligibility
Key inclusion criteria
Adults will be eligible to participate if they meet the following criteria:
1. Adult with newly diagnosed breast cancer
2. Planned treatment includes neo-adjuvant or adjuvant chemotherapy AND/OR endocrine therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults will be not eligible to participate if they meet any of the following criteria:
1. Cognitive impairment or are unable to speak or read written English
2. Unable to access internet/phone app
3. Living in supported residential care
4. Any other co-morbidities where exercise is contra-indicated, at the discretion of the treating specialist

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)
Computer based randomisation using REDCap software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified based on treatment type and exercise history
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
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26646 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 42686 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 314935 0
Charities/Societies/Foundations
Name [1] 314935 0
Royal Perth Hospital Research Foundation
Country [1] 314935 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital Physiotherapy Department
Address
Royal Perth Hospital, Wellington Street Campus, Perth, WA, 6000.
Country
Australia
Secondary sponsor category [1] 316942 0
University
Name [1] 316942 0
Curtin University
Address [1] 316942 0
208 Kent St, Bentley, WA 6102
Country [1] 316942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313926 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 313926 0
East Metropolitan Health Service (EMHS) Research Ethics and Governance Ground Floor, Kirkman House, Royal Perth Hospital Wellington Street, PERTH WA 6000
Ethics committee country [1] 313926 0
Australia
Date submitted for ethics approval [1] 313926 0
15/11/2023
Approval date [1] 313926 0
22/02/2024
Ethics approval number [1] 313926 0

Summary
Brief summary
This study is investigating a state-of-the-art exercise intervention for those undergoing chemotherapy for breast cancer in comparison to usual care.

Who is it for?
You may be eligible for this study if you are an adult with newly diagnosed, non-metastatic breast cancer, with planned treatment including neo-adjuvant or adjuvant chemotherapy and/or endocrine therapy.

Study details
Participants will be randomly allocated to receive either a tailored exercise program, or usual care pathways without individualized exercise prescription. The tailored program will involve supervision of exercise sessions and ongoing personal support. Participants will be asked to fill in questionnaires about their quality of life and absenteeism from work, and other health data including chemotherapy completion rates will also be collected.

It is hoped that findings from this study will help evaluate the utility of a personalised exercise intervention during breast cancer treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129814 0
Mrs Kylie Hill
Address 129814 0
Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
Country 129814 0
Australia
Phone 129814 0
+61 8 9266 1717
Fax 129814 0
Email 129814 0
k.hill@curtin.edu.au
Contact person for public queries
Name 129815 0
Mrs Kylie Hill
Address 129815 0
Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
Country 129815 0
Australia
Phone 129815 0
+61 8 9266 1717
Fax 129815 0
Email 129815 0
k.hill@curtin.edu.au
Contact person for scientific queries
Name 129816 0
Mrs Kylie Hill
Address 129816 0
Curtin University, Faculty of Health Sciences, 208 Kent St, Bentley, WA 6102
Country 129816 0
Australia
Phone 129816 0
+61 8 9266 1717
Fax 129816 0
Email 129816 0
k.hill@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided


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.