Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000436976
Ethics application status
Approved
Date submitted
20/04/2011
Date registered
28/04/2011
Date last updated
17/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a combined group exercise and counseling program on selected physiological and psychological parameters in breast and prostate cancer survivors.
Scientific title
Comparing the changes in quality of life for breast and prostate cancer survivors who participate in a group exercise and counseling program.
Secondary ID [1] 259875 0
nil
Universal Trial Number (UTN)
U1111-1120-3159
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 265463 0
Prostate Cancer 265464 0
Condition category
Condition code
Cancer 265619 265619 0 0
Breast
Cancer 265620 265620 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 arms to this study. Arm 1 and 2 are both group exercise and counseling interventions. Arm 3 is a control group. Arm 1 and 2: subjects participate in a baseline assessment in week 1, group exercise (1 hour, 3x/week) and group counseling (90 minutes, 1x/week) for 8 weeks, then a post-test assessment in week 10, as well as follow up at week 24. The format of exercise and counseling is identical between the arms. The only difference is exercise intensity. All exercise sessions will be supervised by an Accredited Exercise Physiologist and delivered by university students currently enrolled in the Exercise & Sport Science and/or Physiotherapy degrees. All students working on the project will have been trained by the lead investigator on exercise delivery and monitoring. Arm 1 will participate in low to moderate intensity exercise. They will perform aerobic exercise at an intensity of 60-65% of peak aerobic capacity and resistance training at 50-65% of their maximum strength. Arm 2 will participate in moderate to high intensity exercise. They will perform aerobic exercise at an intensity of 75-80% of peak aerobic capacity and resistance training at 65-80% of their maximum strength. All group counselling sessions will be co-facilitated by one certified counsellor and one masters student of counselling. Each counselling session will have a new topic to focus the discussion on, but the counsellors will encourage the participants to steer the conversation to meet their interests and needs. Intervention groups will be formed when at least 6 participants sign up for the course. After baseline assessment, groups will be randomly assigned an arm of the intervention by computer generate random numbers, with even numbers being arm 1 and odd numbers being arm 2. Possible side effects of the intervention include general muscular soreness from exercise and possible increase in swelling if lymphedema present
Intervention code [1] 264295 0
Treatment: Other
Intervention code [2] 264296 0
Rehabilitation
Intervention code [3] 264297 0
Behaviour
Comparator / control treatment
The control group, will participate in the assessments at week 1 and 10 only, and in between will be asked to continue their normal routine. Possible side effects of the fitness assessments include general muscular soreness and possible increase in swelling if lymphedema present
Control group
Active

Outcomes
Primary outcome [1] 262403 0
mean quality of life score as assessed by the Functional Assessment of Cancer Therapy-Breast or Prostate
Timepoint [1] 262403 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls
Primary outcome [2] 262404 0
mean VO2 peak as assessed through a ramped cycle ergometer VO2 peak test
Timepoint [2] 262404 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls
Secondary outcome [1] 273714 0
mean muscular strength as a composite score of maximal push ups, time on plank exercise, and kilograms lifted in a one repetition maximum leg press test
Timepoint [1] 273714 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls
Secondary outcome [2] 273715 0
mean flexibility score as a composite score of centimeters from foot line on a standard sit and reach test and degrees of motion on shoulder goniometery tests of flexion, extension, and abduction
Timepoint [2] 273715 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls
Secondary outcome [3] 273716 0
exercise motivation as assessed by the Behavioral Regulation in Exercise Questionnaire version 2 (BREQ-2)
Timepoint [3] 273716 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls
Secondary outcome [4] 273717 0
mean weekly physical activity as assessed through the International Physical Activity Questionnaire
Timepoint [4] 273717 0
week 1 (baseline), week 10, and week 24 for intervention; baseline and week 10 for controls

Eligibility
Key inclusion criteria
Confirmed stage I, II, or III breast or prostate cancer
Completed acute treatments (surgery, chemotherapy, radiotherapy) within 5 years of enrollment
Completed referral from physician
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute or chronic bone, joint, or muscular pain or abnormality that would compromise ability to complete exercise program.
Metastatic breast or prostate cancer
Unable to understand verbal or written 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)
Participants in the intervention are blinded to the existence of the 2 intervention arms at all times. After the baseline assessment, groups of participants are randomized to their intervention arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator was used to assign each group its intervention arm. Even numbers indicated arm 1 (light intensity exercise) and odd numbers indicated arm 2 (high intensity exercise)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The principal investigator will be completing all the assessments. He will be blinded to treatment arm allocation at baseline assessment (but not at the follow up assessments) by not assigning groups to interventions until after baseline assessments are completed
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 264756 0
University
Name [1] 264756 0
University of Notre Dame Australia
Country [1] 264756 0
Australia
Funding source category [2] 264757 0
Commercial sector/Industry
Name [2] 264757 0
HBF insurance
Country [2] 264757 0
Australia
Funding source category [3] 285538 0
Commercial sector/Industry
Name [3] 285538 0
Sports Medicine Australia
Country [3] 285538 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
PO Box 1225
Fremantle, WA, 6959
Country
Australia
Secondary sponsor category [1] 263877 0
Commercial sector/Industry
Name [1] 263877 0
HBF insurance
Address [1] 263877 0
GPO Box C101, Perth WA 6809
Country [1] 263877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266736 0
University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 266736 0
the Executive Officer of the Human Research Ethics Committee, Research Office, The University of Notre Dame Australia, PO Box 1225 Fremantle WA 6959
Ethics committee country [1] 266736 0
Australia
Date submitted for ethics approval [1] 266736 0
31/03/2011
Approval date [1] 266736 0
19/04/2011
Ethics approval number [1] 266736 0
011024F

Summary
Brief summary
The aim of this research is to trial a theory based group exercise and counseling intervention that addresses questions related to the optimal characteristics of rehabilitation programs, focusing on intensity of exercise. This research will attempt to identify characteristics of both the intervention and participants that contribute to the success of such a program. This information will help Australian breast and prostate cancer survivors reach and maintain their fitness and well being goals and improve their quality of life. The literature so far has shown that exercise and counseling can help improve quality of life in breast and prostate cancer survivors, but there is a need to determine how intense exercise needs to be to make optimal improvements in quality of life. Who is it for? Patients aged 25-75 who have had confirmed stage I, II, or III breast or prostate cancer and also completed acute treatments (surgery, chemotherapy, radiotherapy) within the past 5 years will be eligible for this study. Patients who register their interest must have their physician complete a referral form to clear them for participation. Trial Details Participants will be allocated by the project manager to one of the 3 treatment arms of the study, based upon their availability and course openings. Arm 1 and 2 are both group exercise and counselling interventions, differing in exercise intensity (low to moderate in Arm 1, moderate to high in Arm 2) and lasting 8 weeks. Arm 3 is a control group that maintained their normal routine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32401 0
Address 32401 0
Country 32401 0
Phone 32401 0
Fax 32401 0
Email 32401 0
Contact person for public queries
Name 15648 0
Eric Martin
Address 15648 0
School of Health Sciences
PO Box 1225
Fremantle, WA, 6959
Country 15648 0
Australia
Phone 15648 0
+61 (08) 9433 0906
Fax 15648 0
Email 15648 0
[email protected]
Contact person for scientific queries
Name 6576 0
Prof Helen Parker
Address 6576 0
School of Health Sciences
PO Box 1225
Fremantle, WA, 6959
Country 6576 0
Australia
Phone 6576 0
+61 (08) 9433 0205
Fax 6576 0
Email 6576 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

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