Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000973617
Ethics application status
Approved
Date submitted
17/08/2023
Date registered
7/09/2023
Date last updated
7/09/2023
Date data sharing statement initially provided
7/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise program for breast cancer
Scientific title
A pilot program assessing the impact of an individualised exercise program in routine care for quality of life in early-stage breast cancer
Secondary ID [1] 310407 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 331159 0
Condition category
Condition code
Cancer 327935 327935 0 0
Breast
Physical Medicine / Rehabilitation 328001 328001 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention is evaluating an individualised exercise program that will be conducted and supervised by a physiotherapist. The session(s) may be conducted individually, in a group of up to 8 people, or via telehealth at home based on participant preference. The level of intensity of exercise will be tailored to the person's individual needs and will be monitored using the Borg rate of Perceived Excursion scale and based on strength and physical fitness measures conducted by the physiotherapist. The sessions will be conducted weekly for a duration of 30-60 minutes and the total length of the exercise program is 12 weeks. Participants will complete exercise diaries and records of sessions will be kept.

The program is tailored to individual needs based on physical fitness and strength testing conducted by the physiotherapist with consideration of the person's stage of treatment.

Examples of the exercises prescribed may include biceps curls, squats, exercise bike, bridges. All participants will complete a warm up and cool down as part of the session.
Intervention code [1] 326805 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335794 0
Quality of life measured by Functional Assessment of Cancer Therapy – Breast (FACT-B)
Timepoint [1] 335794 0
Baseline, 3 months, 6 months, 12 months post-commencement of intervention
Secondary outcome [1] 425666 0
Acceptability measured by the Acceptability of Intervention Measure (AIM)
Timepoint [1] 425666 0
3 months post-commencement of intervention
Secondary outcome [2] 425924 0
Feasibility as measured by the Feasibility of Intervention measure (FIM)
Timepoint [2] 425924 0
3 months post-commencement of intervention
Secondary outcome [3] 425925 0
Appropriateness of intervention as measured by the Intervention appropriateness measure (IAM)
Timepoint [3] 425925 0
3 months post-commencement of intervention

Eligibility
Key inclusion criteria
Early-stage breast cancer patients will be eligible to participate if they are 18 years and over of age, receiving treatment for breast cancer at Westmead Hospital, able to participate in exercise sessions, able to provide consent, and have sufficient command of the English language or access to a health care interpreter to be able to complete questionnaire data.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they: (1) have an absolute contraindication to physical activity as determined by their treating medical team; (2) are unable to commit to participating in the exercise program; (3) have significant cognitive impairment.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A post hoc power analysis will be calculated for the final sample, which is one of convenience, but aiming for 120 participants. Descriptive statistics (means, median scores and percentages) will be performed to assess change in each dependant variable over time. Repeated measures of analysis of variance (ANOVA/ANCOVA) will be performed for each dependant variable to determine whether there were any statistically significant differences over the time points (baseline, 3 months, 6 months, 12 months) with significance accepted at p < 0.05 and Scheffe test used for pos-hoc comparisons (SPSS Chicago IL, USA). Exercise adherence will be measured by calculating the proportion of sessions attended/scheduled. All focus group discussions and interviews will be transcribed and a thematic approach using Framework analysis will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
2/09/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25406 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 41145 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314616 0
Hospital
Name [1] 314616 0
Westmead Hospital
Country [1] 314616 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
PO Box 533
Wentworthville NSW 2145
Country
Australia
Secondary sponsor category [1] 316576 0
None
Name [1] 316576 0
Address [1] 316576 0
Country [1] 316576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313640 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313640 0
PO Box 533
Wentworthville NSW 2145
Ethics committee country [1] 313640 0
Australia
Date submitted for ethics approval [1] 313640 0
Approval date [1] 313640 0
23/06/2023
Ethics approval number [1] 313640 0

Summary
Brief summary
This study aims to evaluate the effectiveness of an individualised exercise program for improving patient-reported health outcomes for quality of life in people with breast cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years and over, and have received a diagnosis of early-stage breast cancer, are receiving treatment at Westmead Hospital and are able to participate in exercise sessions.

Study details
Participants will complete an individualised and supervised 12 week exercise program which may be conducted individually, as part of a group at Westmead Hospital or via telehealth at home. The exercise program will consist of a warm up and cool down, and exercises including strengthening. The program duration is 30-60 minutes weekly and for a length of 12 weeks. All participants will undergo physical assessment and complete questionnaires at baseline, 3 months, 6 months and 12 months.

Findings from this study will help evaluate the implementation of an exercise program for breast cancer into usual care at Westmead Hospital, as well as identify barriers and enablers to implementation and uptake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128838 0
Ms Dragana Ceprnja
Address 128838 0
Physiotherapy DepartmentWestmead HospitalPO Box 533 Wentworthville NSW 2145
Country 128838 0
Australia
Phone 128838 0
+61 2 8890 6502
Fax 128838 0
Email 128838 0
[email protected]
Contact person for public queries
Name 128839 0
Ms Dragana Ceprnja
Address 128839 0
Physiotherapy DepartmentWestmead HospitalPO Box 533 Wentowrthville NSW 2145
Country 128839 0
Australia
Phone 128839 0
+61 2 8890 6502
Fax 128839 0
Email 128839 0
[email protected]
Contact person for scientific queries
Name 128840 0
Ms Dragana Ceprnja
Address 128840 0
Physiotherapy DepartmentWestmead HospitalPO Box 533 Wentowrthville NSW 2145
Country 128840 0
Australia
Phone 128840 0
+61 2 8890 6502
Fax 128840 0
Email 128840 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.