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Trial registered on ANZCTR


Registration number
ACTRN12611001266954
Ethics application status
Approved
Date submitted
5/12/2011
Date registered
12/12/2011
Date last updated
18/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an exercise program on cancer related fatigue in breast cancer patients undergoing radical radiotherapy
Scientific title
Efficacy of an exercise program on cancer related fatigue in breast cancer patients undergoing radical radiotherapy
Secondary ID [1] 273544 0
Nil
Universal Trial Number (UTN)
U1111-1126-2631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 279346 0
Condition category
Condition code
Cancer 279531 279531 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Group:
The 9-12 week, home based exercise intervention will involve the prescription of a combination of aerobic (e.g. walking, cycling etc.), resistance (e.g. upper and lower body resistance based exercises) and flexibility exercises (e.g. stretching). The duration of exercise sessions and number of exercise sessions per week will be individually determined with the goal of achieving 150 minutes of moderate intensity aerobic exercise and 2-3 resistance exercise sessions per week. The exercise program will be relative to the level of fitness and fatigue each patient presents with and individualised to their age, personal preferences and any pre-existing conditions. This will be determined during a consultation with an exercise physiologist before the start of the intervention. Participants will continue their usual medical care for breast cancer for the duration of the intervention.
Intervention code [1] 283857 0
Lifestyle
Comparator / control treatment
Usual Care Group:
Participants will continue their usual medical care for breast cancer for the duration of the intervention. Usual medical care will be determined on a case by case basis by the individual participants oncologists.
Control group
Active

Outcomes
Primary outcome [1] 286099 0
Cancer Related Fatigue:
Cancer related fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. The FACIT-F is a 13 item scale commonly used to assess fatigue in cancer patients.
Timepoint [1] 286099 0
1) Baseline (pre-intervention); 2) Post-Radiotherapy (mid-intervention); 3) Post-Exercise (post-intervention); 4) Follow-up (6 months post-radiotherapy).
Secondary outcome [1] 295144 0
Quality of Life:
Health related quality of life will be assessed using three questionnaires, the SF-36 Health Survey (SF-36), the Patient Reported Outcomes Measurement Information System 57 survey (PROMIS 57) and the Functional Assessment of Cancer Therapy for patients with breast cancer (FACT-B).
Timepoint [1] 295144 0
1) Baseline (pre-intervention); 2) Post-Radiotherapy (mid-intervention); 3) Post-Exercise (post-intervention); 4) Follow-up (6 months post-radiotherapy).
Secondary outcome [2] 295145 0
Radiotherapy Completion Rates & Adverse Side Effects:
Adherence to prescribed radiotherapy treatments will be recorded using standard clinical measures. Completion rate will be reported as the percentage of the planned dose and planned fractions that are completed during the treatment course. The presence and severity of any adverse side effects will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events and Common Toxicity Criteria protocols
Timepoint [2] 295145 0
1) Baseline (pre-intervention); 2) Post-Radiotherapy (mid-intervention); 3) Post-Exercise (post-intervention); 4) Follow-up (6 months post-radiotherapy).
Secondary outcome [3] 295146 0
Adherence to & Adverse Side Effects from the Exercise Program:
Adherence to the exercise program will be recorded using details log books. The frequency, duration and intensity of exercise will be examined across all exercise modalities (i.e. aerobic, resistance and flexibility). The occurrence and severity of any adverse events including exacerbation of breast cancer treatment related symptoms and/or musculoskeletal complications (muscle strains, fractures etc.) will be recorded throughout the intervention and follow-up period.
Timepoint [3] 295146 0
1) Baseline (pre-intervention); 2) Post-Radiotherapy (mid-intervention); 3) Post-Exercise (post-intervention); 4) Follow-up (6 months post-radiotherapy).

Eligibility
Key inclusion criteria
1) A histological diagnosis of breast cancer
2) Prescribed radical radiotherapy treatment for 3-6 weeks.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Bone metastatic disease
2) Any cardiovascular, musculoskeletal or neurological condition that could inhibit them from exercising or put them at risk during exercise
3) Difficulties reading and/or understanding English.

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)
Central randomization by computer.

Written informed consent will be required prior to any testing or randomisation. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation). Randomisation is at the level of the individual patient, and will be stratified by age, treatment history and number of radiotherapy fractions prescribed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284333 0
University
Name [1] 284333 0
Edith Cowan University
Address [1] 284333 0
270 Joondalup Drive, Joondalup WA 6027
Country [1] 284333 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 283276 0
Other
Name [1] 283276 0
Genesis Care
Address [1] 283276 0
24 Salvado Road, Wembley, WA 6014
Country [1] 283276 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286294 0
Ethics Cowan University Human Research Ethics Committee
Ethics committee address [1] 286294 0
270 Joondalup Drive, Joondalup, WA 6027
Ethics committee country [1] 286294 0
Australia
Date submitted for ethics approval [1] 286294 0
Approval date [1] 286294 0
28/11/2011
Ethics approval number [1] 286294 0
7692 CORMIE

Summary
Brief summary
This study aims to determine the impact of a home based exercise program on cancer related fatigue in patients receiving radical radiotherapy for the treatment of breast cancer.

Who is it for?
You may be eligible to join this study if you are a woman with breast cancer who has been prescribed radical radiotherapy treatment for 3-6 weeks.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive a home based exercise program which involves resistance (e.g. movements performed against resistance), aerobic (e.g. walking, jogging, cycling) and flexibility (e.g. stretching) exercises performed for a 9-12 week period during and after radiotherapy. The other group will be assigned to usual care (e.g. no treatment) for a 9-12 week period during and after radiotherapy.

Participants will complete questionnaires assessing fatigue, quality of life, physical activity levels and physical activity motivation on 4 occasions (before starting radiotherapy, after finishing radiotherapy, 6 weeks after finishing radiotherapy and 6 months after finishing radiotherapy).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33504 0
Dr Prue Cormie
Address 33504 0
Edith Cowan University Health and Wellness Institute
270 Joondalup Drive, Joondalup WA 6027
Country 33504 0
Australia
Phone 33504 0
+61 8 6304 3418
Fax 33504 0
Email 33504 0
p.cormie@ecu.edu.au
Contact person for public queries
Name 16751 0
Dr Dr Prue Cormie
Address 16751 0
ECU Health & Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 16751 0
Australia
Phone 16751 0
+61 8 6304 3418
Fax 16751 0
Email 16751 0
p.cormie@ecu.edu.au
Contact person for scientific queries
Name 7679 0
Dr Dr Prue Cormie
Address 7679 0
ECU Health & Wellness Institute
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 7679 0
Australia
Phone 7679 0
+61 8 6304 3418
Fax 7679 0
Email 7679 0
p.cormie@ecu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary