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Trial registered on ANZCTR


Registration number
ACTRN12610000609055
Ethics application status
Approved
Date submitted
27/07/2010
Date registered
27/07/2010
Date last updated
5/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of a Referral and Physical Activity Program for Survivors of Prostate Cancer
Scientific title
The Efficacy of a Referral and Physical Activity Program, Compared to Usual Care, for Survivors of Prostate Cancer to Increase Participation in Physical Activity
Secondary ID [1] 252304 0
Nil
Universal Trial Number (UTN)
Trial acronym
ENGAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer survivors 257815 0
Condition category
Condition code
Cancer 257986 257986 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve clinicians referring participants to an Active Exercise Program, which comprises individual and small group supervised sessions and individual home-based physical activity. Participants will initially undertake a one-on-one session with the exercise physiologist, which will include a discussion on the needs of the participant, physical activity preferences, goals, and strategies for overcoming any barriers to performing physical activity. A 12-week program will be undertaken comprising a combination of supervised individual and small group physical activity sessions and home-based physical activity. Within the supervised, the exercise program will be adapted to suit the ability of the participant. The exercise physiologist will lead the small group sessions two times per week and the participant will be advised to undertake their home-based program for a further one day per week. Each supervised session will last approximately 50 minutes and participants will be encouraged to socialise following the sessions. The program will also account for co-morbidities, health conditions, physical limitations and individual preferences. The Australian Association for Exercise and Sport Science recommends that cancer survivors participate in low to moderate intensity physical activity, with regular frequency (3-5 times/week), for at least 20 minutes per session, involving aerobic, resistance or mixed exercise types.
Intervention code [1] 256878 0
Behaviour
Intervention code [2] 256884 0
Lifestyle
Intervention code [3] 256885 0
Treatment: Other
Comparator / control treatment
Clinicians will provide usual advice regarding physical activity, but not refer participants to the exercise program.
Control group
Active

Outcomes
Primary outcome [1] 258852 0
Participation in physical activity - measured using the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire
Timepoint [1] 258852 0
T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1
Secondary outcome [1] 264974 0
Cancer-specific quality of life - measured using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTCQLQ-C30 V3) and the prostate tumour-specific module (EORTCQLQ-PR25)
Timepoint [1] 264974 0
T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1
Secondary outcome [2] 264975 0
Anxiety related to prostate cancer - measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Timepoint [2] 264975 0
T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1
Secondary outcome [3] 264976 0
Depressive symptoms - measured using the Centre for Epidemiological Studies Depression Inventory (CES-D)
Timepoint [3] 264976 0
T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1

Eligibility
Key inclusion criteria
Adult males who: (1) have completed active treatment for prostate cancer (hormonal therapy exempt) three-12 months earlier (2) have been treated with curative intent (3) are stages I-III, and (4) have the ability to complete English language versions of the participant surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded from this study if they have musculoskeletal, cardiovascular, or neurological disorders that could limit them from exercising. The patients' treating clinicians will assess their eligibility for the study.

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)
On completion of active treatment, prostate cancer patients will be considered for the study at their three-12 month follow up consultation. Eligible patients will be identified by the health service nurses prior to presentation to either the public health service outpatient clinic or private health service rooms for their follow up consultation. The primary investigator will randomly assign clinicians to one of two study arms using computer generated random numbers. Clinicians in the intervention arm will follow a standardized script to refer participants to the physical activity program and will provide patients with a referral slip to the program. Patients of clinicians assigned to the control arm will receive usual advice regarding physical activity. During clinic sessions, members of the research team will approach eligible patients and introduce the study to the patient, provide an information package and seek verbal approval to follow them up within 48 hours regarding their interest in participating in the study. Once the consent form has been returned, the project manager will arrange for the participant’s first physical activity session. Allocation is not concealed.
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
Masking / blinding
Open (masking not 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
1/10/2010
Actual
5/10/2011
Date of last participant enrolment
Anticipated
Actual
28/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257344 0
Government body
Name [1] 257344 0
Australian Research Council
Country [1] 257344 0
Australia
Funding source category [2] 257345 0
Charities/Societies/Foundations
Name [2] 257345 0
Prostate Cancer Foundation Australia
Country [2] 257345 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 256585 0
University
Name [1] 256585 0
University of Alberta
Address [1] 256585 0
Edmonton, Alberta, Canada
T6G 2R3
Country [1] 256585 0
Canada
Secondary sponsor category [2] 256586 0
University
Name [2] 256586 0
Victoria University
Address [2] 256586 0
PO Box 14428
Melbourne VIC 8001
Country [2] 256586 0
Australia
Other collaborator category [1] 251401 0
Hospital
Name [1] 251401 0
Epworth Healthcare
Address [1] 251401 0
89 Bridge Road
Richmond VIC 3121
Country [1] 251401 0
Australia
Other collaborator category [2] 251402 0
Hospital
Name [2] 251402 0
Eastern Health
Address [2] 251402 0
5 Arnold St
Box Hill VIC 3128
Country [2] 251402 0
Australia
Other collaborator category [3] 251403 0
Hospital
Name [3] 251403 0
Peter MacCallum Cancer Centre
Address [3] 251403 0
Locked Bag 1
A'Beckett Street VIC 8006
Country [3] 251403 0
Australia
Other collaborator category [4] 251404 0
Charities/Societies/Foundations
Name [4] 251404 0
YMCA Victoria
Address [4] 251404 0
582 Heidelberg Road
Fairfield VIC 3078
Country [4] 251404 0
Australia
Other collaborator category [5] 251405 0
Government body
Name [5] 251405 0
North Eastern Metropolitan Integrated Cancer Service
Address [5] 251405 0
PO Box 5555
Heidelberg, VIC 3084
Country [5] 251405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259365 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 259365 0
Eastern Health Research and Ethics Office
Level 3 Arnold Building
5 Arnold Street
Box Hill VIC 3128
Ethics committee country [1] 259365 0
Australia
Date submitted for ethics approval [1] 259365 0
30/08/2010
Approval date [1] 259365 0
11/02/2011
Ethics approval number [1] 259365 0
E32-1011
Ethics committee name [2] 259366 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [2] 259366 0
Human Research Ethics Committee Coordinator
Epworth HealthCare
89 Bridge Road
5LP
Richmond VIC 3121
Ethics committee country [2] 259366 0
Australia
Date submitted for ethics approval [2] 259366 0
30/08/2010
Approval date [2] 259366 0
15/12/2010
Ethics approval number [2] 259366 0
50410
Ethics committee name [3] 259367 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [3] 259367 0
Peter MacCallum Cancer Centre Ethics Committee
Peter MacCullum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Ethics committee country [3] 259367 0
Australia
Date submitted for ethics approval [3] 259367 0
30/08/2010
Approval date [3] 259367 0
11/04/2011
Ethics approval number [3] 259367 0
10/101
Ethics committee name [4] 259368 0
Deakin University Human Research Ethics Committee
Ethics committee address [4] 259368 0
Deakin University Human Research Ethics Committee
Office of Research Integrity, Deakin University
Research Services
221 Burwood Highway
Burwood VIC 3125
Ethics committee country [4] 259368 0
Australia
Date submitted for ethics approval [4] 259368 0
30/09/2010
Approval date [4] 259368 0
19/04/2011
Ethics approval number [4] 259368 0
2011-085
Ethics committee name [5] 269475 0
Austin Health Human Research Ethics Committee
Ethics committee address [5] 269475 0
Research Ethics Unit, Henry Buck Building
Austin Hospital
145 Studley Road,
Heidelberg, Vic 3084
Ethics committee country [5] 269475 0
Australia
Date submitted for ethics approval [5] 269475 0
21/07/2011
Approval date [5] 269475 0
Ethics approval number [5] 269475 0
04339

Summary
Brief summary
There is evidence that engaging in physical activity improves the physical health of prostate cancer survivors. Despite this evidence, men who survive prostate cancer do not engage in recommended levels of physical activity. The aim of this study is to investigate the potential influence clinicians could have on increasing physical activity levels among prostate cancer survivors, by referring cancer survivors to a physical activity program, with expert involvement from exercise physiologists. The participants will be 220 survivors of prostate cancer, defined as men who have completed active treatment (hormone treatment exempt) for prostate cancer three-12 months prior. The study has been designed as a randomised controlled trial to test the efficacy of an intervention (i.e., a clinician’s referral to a physical activity program) to generate a) behaviour change by increasing physical activity levels that is sustained over time and b) improve psychosocial and quality of life outcomes among prostate cancer survivors. The patients’ treating clinicians will be randomised to either the intervention arm or control arm of the trial. The intervention will involve clinicians referring participants to an Active Exercise Program, which comprises 12 weeks of small group sessions and individual home-based physical activity. Patients of clinicians assigned to the control arm will receive usual advice regarding physical activity, given the information and consent form, and invited to be involved in the study by the clinician. The main outcomes that will be measured in this trial are participation in physical activity, cancer-specific quality of life, anxiety relating to prostate cancer, depressed mood, and objective physical functioning. Measurements of these outcomes will be made using standard questionnaires. The questionnaires will be administered baseline (T1), on completion of the intervention (T2), and at six-(T3) and 12-months post-recruitment (T4). Objective physical functioning will be measures at baseline (T1) and on completion of intervention (T2). This study will inform the development of a physical activity program for prostate cancer survivors which could become available across Victorian YMCA facilities and ultimately across Australia.
Trial website
Trial related presentations / publications
Livingston, P.M., Salmon, J., Courneya, K.S., Gaskin, C.J., Craike, M., Botti, M., Broadbent, S., & Kent, B. (2011). Efficacy of a Referral and Physical Activity Program for Survivors of Prostate Cancer [ENGAGE]: Rationale and Design for a Cluster Randomised Controlled Trial. BMC Cancer, 11:237 doi:10.1186/1471-2407-11-237
Public notes

Contacts
Principal investigator
Name 31436 0
Prof Trish Livingston
Address 31436 0
Deakin University, 221 Burwood HWY, Burwood, 3125, Australia
Country 31436 0
Australia
Phone 31436 0
+61392446609
Fax 31436 0
Email 31436 0
trish.livingston@deakin.edu.au
Contact person for public queries
Name 14683 0
Prof Trish Livingston
Address 14683 0
Faculty of Health, 221 Burwood Highway Burwood VIC 3125
Country 14683 0
Australia
Phone 14683 0
+61392446909
Fax 14683 0
+61392446159
Email 14683 0
trish.livingston@deakin.edu.au
Contact person for scientific queries
Name 5611 0
Prof Trish Livingston
Address 5611 0
Faculty of Health, 221 Burwood Highway Burwood VIC 3125
Country 5611 0
Australia
Phone 5611 0
+61392446909
Fax 5611 0
+61392446159
Email 5611 0
trish.livingston@deakin.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a referral and physical activity program for survivors of prostate cancer [ENGAGE]: Rationale and design for a cluster randomised controlled trial.2011https://dx.doi.org/10.1186/1471-2407-11-237
EmbaseAssociations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors.2016https://dx.doi.org/10.1007/s10552-016-0787-5
EmbaseFitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study.2016
EmbaseMechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial.2018https://dx.doi.org/10.1093/abm/kax055
N.B. These documents automatically identified may not have been verified by the study sponsor.