Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000233527
Ethics application status
Not yet submitted
Date submitted
9/05/2006
Date registered
13/06/2006
Date last updated
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise for Health: A breast cancer recovery project
Scientific title
A randomised controlled trial of exercise interventions in breast cancer patients: measuring feasibility and effect on recovery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 1211 0
Condition category
Condition code
Cancer 1296 1296 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with a diagnosis of unilateral breast cancer will be recruited from 4 Brisbane hospitals and randomised into one of three arms: supervised exercise program, unsupervised exercise program or standard care.
Intervention arms:
Intervention 1 - Supervised exercise program: Participants allocated to this group will receive a workbook that includes information relating to the exercise program. All supervised sessions will be individual sessions led by an Exercise Physiologist. Sessions will run from 20 mins to 60 mins. They will progressively increase over time. The first intervention session is scheduled 6 weeks post surgery. This intervention progresses women from a supervised setting to an unsupervised exercise setting over 8 months.
Intervention 2 - Unsupervised mail-based exercise program with telephone follow-up support: Participants allocated to this group will receive the same workbook as those assigned to intervention 1. Telephone support will be used to supplement the print information as well as to provide motivation for exercise adherence.
Duration of the intervention: 8 months
Intervention code [1] 1030 0
Rehabilitation
Comparator / control treatment
Standard care. Duration of the intervention: 8 months
Control group
Active

Outcomes
Primary outcome [1] 1770 0
Quality of life.
Timepoint [1] 1770 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Primary outcome [2] 1771 0
Upper body function.
Timepoint [2] 1771 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Secondary outcome [1] 3117 0
fatigue
Timepoint [1] 3117 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Secondary outcome [2] 3118 0
lymphoedema
Timepoint [2] 3118 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Secondary outcome [3] 3119 0
physical activity levels
Timepoint [3] 3119 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Secondary outcome [4] 3120 0
management of rehabilitation of cancer
Timepoint [4] 3120 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.
Secondary outcome [5] 3121 0
body composition
Timepoint [5] 3121 0
Measured at 3 time points: 4 weeks post breast cancer surgery, 6 months post-surgery and 12 months post-surgey.

Eligibility
Key inclusion criteria
Diagnosis of unilateral breast cancer, live in Brisbane area, under the care of one of the participating clinicians, willing to be randomised into one of three intervention arms .
Minimum age
20 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those planning to move away from the area over the next 12 months, those pregnant or lactating or planning to become pregnant during the study, those who have plans for additional surgery during the study period, those who have a medical condition or are taking medications that would prohibit participation in any of the research protocol arms.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1422 0
Charities/Societies/Foundations
Name [1] 1422 0
National Breast Cancer Foundation
Country [1] 1422 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 1250 0
Other
Name [1] 1250 0
Institute of Health and Biomedical Innovation
Address [1] 1250 0
Country [1] 1250 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2791 0
Queensland University of Technology
Ethics committee address [1] 2791 0
Ethics committee country [1] 2791 0
Australia
Date submitted for ethics approval [1] 2791 0
Approval date [1] 2791 0
Ethics approval number [1] 2791 0
Ethics committee name [2] 2792 0
Royal Brisbane and Women's Hospital
Ethics committee address [2] 2792 0
Ethics committee country [2] 2792 0
Australia
Date submitted for ethics approval [2] 2792 0
Approval date [2] 2792 0
Ethics approval number [2] 2792 0
Ethics committee name [3] 2793 0
Mater Private and Public Hospital
Ethics committee address [3] 2793 0
Ethics committee country [3] 2793 0
Australia
Date submitted for ethics approval [3] 2793 0
Approval date [3] 2793 0
Ethics approval number [3] 2793 0
Ethics committee name [4] 2794 0
Wesley Hospital
Ethics committee address [4] 2794 0
Ethics committee country [4] 2794 0
Australia
Date submitted for ethics approval [4] 2794 0
Approval date [4] 2794 0
Ethics approval number [4] 2794 0

Summary
Brief summary
This project will provide valuable information in relation to the feasibility of integrating supervised versus unsupervised exercise interventions into clinical practice. It will also enable a better understanding of the physical and psychosocial benefits attained and sustained through participation in the interventions in comparison to current care.
The exercise physiologist will not be aware during the data collection testing phases which intervention arm the participants have been allocated to.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35442 0
Address 35442 0
Country 35442 0
Phone 35442 0
Fax 35442 0
Email 35442 0
Contact person for public queries
Name 10219 0
Dr Sandi Hayes
Address 10219 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 10219 0
Australia
Phone 10219 0
+61 7 38649645
Fax 10219 0
+61 7 38643130
Email 10219 0
[email protected]
Contact person for scientific queries
Name 1147 0
Dr Sandi Hayes
Address 1147 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 1147 0
Australia
Phone 1147 0
+61 7 38649645
Fax 1147 0
+61 7 38643130
Email 1147 0
[email protected]

No information has been provided regarding IPD availability


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.