Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000809235
Ethics application status
Approved
Date submitted
11/09/2009
Date registered
17/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for health: A breast cancer recovery project
Scientific title
Using the telephone to promote exercise-based rehabilitation in regional/rural/remote Australian breast cancer survivors
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 243706 0
Condition category
Condition code
Cancer 239970 239970 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Half of women recruited into the study will be randomly assigned to a telephone-delivered exercise rehabilitation program and will receive an exercise workbook, an exercise tracker to log their physical activity and telephone support calls over 8 months from a study-trained Exercise Physiologist. Exercise Physiologists will contact participants regularly over 8 months to assist them to progress through their workbook to develop a safe and appropriate exercise regimen (16 calls over 8 months).

The final goal is to have women exercising at least 4 times per week, at moderate intensities, with exercise sessions lasting 45+ minutes. To achieve this goal, the exercise programs will be gradually progressed across the weeks by introducing different types of exercise and slowly increasing their intensity and duration. Progression in exercise will depend on the participant and how she is dealing with the exercises and her breast cancer treatment.
Intervention code [1] 241245 0
Rehabilitation
Comparator / control treatment
Control group: The other half of women recruited into the study will be randomly assigned to the usual care control group and will participate in all study assessments and receive usual care from their treating clinicians, which generally includes information booklets on recovery following breast cancer treatment. Duration of the intervention is 8 months.
Control group
Active

Outcomes
Primary outcome [1] 240771 0
Quality of Life using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) instrument
Timepoint [1] 240771 0
Measured at 3 time points: 4 weeks post breast cancer surgery (baseline), 6 months post-surgery and 12 months post-surgery
Primary outcome [2] 240772 0
Upper body function using the Disability of the Arm, Shoulder and Hand (DASH) instrument
Timepoint [2] 240772 0
Measured at 3 time points: 4 weeks post breast cancer surgery (baseline), 6 months post-surgery and 12 months post-surgery
Primary outcome [3] 240773 0
Fatigue using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) instrument
Timepoint [3] 240773 0
Measured at 3 time points: 4 weeks post breast cancer surgery (baseline), 6 months post-surgery and 12 months post-surgery
Primary outcome [4] 240879 0
Feasibility measured by the following indicators: Consent rate; % intervention group participants receiving 75% or more of scheduled calls; participant satisfaction ratings
Timepoint [4] 240879 0
Measured at 12 months post-surgery
Secondary outcome [1] 257446 0
Physical activity levels using the Active Australia Survey and the Community Healthy Activities Models Program for Seniors (CHAMPS) survey
Timepoint [1] 257446 0
Measured at 3 time points: 4 weeks post breast cancer surgery (baseline), 6 months post-surgery and 12 months post-surgery
Secondary outcome [2] 257447 0
Lymphoedema assessed via self-report questionnaire items
Timepoint [2] 257447 0
Measured at 3 time points: 4 weeks post breast cancer surgery (baseline), 6 months post-surgery and 12 months post-surgery

Eligibility
Key inclusion criteria
First diagnosis of breast cancer; residing in a regional, remote or rural area according to the Australian Standard Geographical Classification (2001); willing to accept a random assignment to the control or exercise rehabilitation program group
Minimum age
20 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those planning on moving away from current residence during the study period; those pregnant, lactating or planning to fall pregnant during the study period; those planning to have 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 protocols

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)
Randomisation by computer after eligibility status determined
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 243624 0
Charities/Societies/Foundations
Name [1] 243624 0
National Breast Cancer Foundation
Country [1] 243624 0
Australia
Primary sponsor type
University
Name
Cancer Prevention Research Centre, School of Population Health, The University of Queensland
Address
Level 3, Public Health Building
The University of Queensland
Herston Road
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 237072 0
None
Name [1] 237072 0
Address [1] 237072 0
Country [1] 237072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243748 0
Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 243748 0
The Ethics Officer Research andResearch Training Division Cumbrae-Stewart Building The University of Queensland ST. LUCIA QLD 4072
Ethics committee country [1] 243748 0
Australia
Date submitted for ethics approval [1] 243748 0
Approval date [1] 243748 0
06/02/2007
Ethics approval number [1] 243748 0
EC00176
Ethics committee name [2] 243749 0
Toowoomba & Darling Downs Health Service District Human Research Ethics Committee
Ethics committee address [2] 243749 0
Level 2 Cossart House TDDHSD Locked Bag 2 TOOWOOMBA QLD 4350
Ethics committee country [2] 243749 0
Australia
Date submitted for ethics approval [2] 243749 0
Approval date [2] 243749 0
14/12/2006
Ethics approval number [2] 243749 0
EC00182
Ethics committee name [3] 243751 0
St Vincent's and Holy Spirit Health
Ethics committee address [3] 243751 0
PO Box 555 SPRING HILL QLD 4004
Ethics committee country [3] 243751 0
Australia
Date submitted for ethics approval [3] 243751 0
Approval date [3] 243751 0
08/12/2006
Ethics approval number [3] 243751 0
EC00324
Ethics committee name [4] 243752 0
Rockhampton Health Service District Human Research Ethics Committee
Ethics committee address [4] 243752 0
C/- Executive director of Medical Services Rockhampton Hospital Canning Street ROCKHAMPTON QLD 4700
Ethics committee country [4] 243752 0
Australia
Date submitted for ethics approval [4] 243752 0
Approval date [4] 243752 0
08/12/2006
Ethics approval number [4] 243752 0
EC00173
Ethics committee name [5] 243753 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [5] 243753 0
RBWH Human Research Ethics Level 7, Block 7 Royal Brisbane and Women's Hospital Butterfield Street
Ethics committee country [5] 243753 0
Australia
Date submitted for ethics approval [5] 243753 0
Approval date [5] 243753 0
16/02/2007
Ethics approval number [5] 243753 0
EC00172
Ethics committee name [6] 243754 0
Greenslopes Private Hospital Human Research Ethics Committee
Ethics committee address [6] 243754 0
Greenslopes Private Hospital Ethics Committee Newdgate Street GREENSLOPES QLD 4120
Ethics committee country [6] 243754 0
Australia
Date submitted for ethics approval [6] 243754 0
Approval date [6] 243754 0
13/02/2007
Ethics approval number [6] 243754 0
EC00161
Ethics committee name [7] 243755 0
Cairns & Hinterland Health Service District Ethics Committee
Ethics committee address [7] 243755 0
Cairns & Hinterland Health Service District HREC Cairns Base Hospital PO Box 902 CAIRNS QLD 4870
Ethics committee country [7] 243755 0
Australia
Date submitted for ethics approval [7] 243755 0
Approval date [7] 243755 0
01/03/2007
Ethics approval number [7] 243755 0
EC00157
Ethics committee name [8] 243756 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [8] 243756 0
Mater Health Services Research Ethics Room 235, Level 2, Aubigny Place Raymond Terrace SOUTH BRISBANE QLD 4101
Ethics committee country [8] 243756 0
Australia
Date submitted for ethics approval [8] 243756 0
Approval date [8] 243756 0
07/12/2006
Ethics approval number [8] 243756 0
EC00332

Summary
Brief summary
The long-term presence of physical and psychosocial symptoms following breast cancer treatment is well established. However, Queensland is a geographically dispersed state, where many women with breast cancer live in rural and remote areas with limited support resources. Queensland-based research highlights that these women are more likely to have more extensive surgeries, and experience poorer quality of life and higher unmet needs.

Exercise is one strategy with a large evidence base supporting its effectiveness in reducing symptoms and improving quality of life (QoL) among women following breast cancer. However, the majority of studies have been conducted overseas, and with women in urban areas.

This pilot study will evaluate the feasibility of a telephone-delivered exercise-based rehabilitation support program for women newly diagnosed with breast cancer living in regional, rural and remote areas of Queensland, Australia. Feasibility and effect size data from the pilot study will be used to refine the intervention and to inform a subsequent application for a fully powered randomized controlled trial.

This study forms an arm of a larger study that is currently being undertaken (ACTRN12606000233527) with an urban sample of women who have received breast cancer treatment via Brisbane-based hospitals (Royal Brisbane & Women’s Hospital, Mater Hospital and Wesley Hospital).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30169 0
Address 30169 0
Country 30169 0
Phone 30169 0
Fax 30169 0
Email 30169 0
Contact person for public queries
Name 13416 0
Elizabeth Eakin
Address 13416 0
Cancer Prevention Research Centre, School of Population Health, Level 3 Public Health Building, The University of Queensland, Herston Road Herston QLD 4006
Country 13416 0
Australia
Phone 13416 0
+61 7 3346 4692
Fax 13416 0
+61 7 3365 5540
Email 13416 0
[email protected]
Contact person for scientific queries
Name 4344 0
Elizabeth Eakin
Address 4344 0
Cancer Prevention Research Centre, School of Population Health, Level 3 Public Health Building, The University of Queensland, Herston Road Herston QLD 4006
Country 4344 0
Australia
Phone 4344 0
+61 7 3346 4692
Fax 4344 0
+61 7 3365 5540
Email 4344 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.