ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

ENGAGE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate cancer survivors

Condition category

Condition code

Cancer

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Participation in physical activity - measured using the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire

Timepoint [1]

T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1

Secondary outcome [1]

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]

T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1

Secondary outcome [2]

Anxiety related to prostate cancer - measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

Timepoint [2]

T1 = pre-intervention
T2 = post-intervention (12 weeks from T1)
T3 = 6 months from T1
T4 = 12 months from T1

Secondary outcome [3]

Depressive symptoms - measured using the Centre for Epidemiological Studies Depression Inventory (CES-D)

Timepoint [3]

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]

Government body

Name [1]

Australian Research Council

Address [1]

GPO Box 2702
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Prostate Cancer Foundation Australia

Address [2]

P.O.Box 1332
Lane Cove NSW 1595

Country [2]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Highway
Burwood VIC 3125

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Alberta

Address [1]

Edmonton, Alberta, Canada
T6G 2R3

Country [1]

Canada

Secondary sponsor category [2]

University

Name [2]

Victoria University

Address [2]

PO Box 14428
Melbourne VIC 8001

Country [2]

Australia

Other collaborator category [1]

Hospital

Name [1]

Epworth Healthcare

Address [1]

89 Bridge Road
Richmond VIC 3121

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Eastern Health

Address [2]

5 Arnold St
Box Hill VIC 3128

Country [2]

Australia

Other collaborator category [3]

Hospital

Name [3]

Peter MacCallum Cancer Centre

Address [3]

Locked Bag 1
A'Beckett Street VIC 8006

Country [3]

Australia

Other collaborator category [4]

Charities/Societies/Foundations

Name [4]

YMCA Victoria

Address [4]

582 Heidelberg Road
Fairfield VIC 3078

Country [4]

Australia

Other collaborator category [5]

Government body

Name [5]

North Eastern Metropolitan Integrated Cancer Service

Address [5]

PO Box 5555
Heidelberg, VIC 3084

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Research and Ethics Committee

Ethics committee address [1]

Eastern Health Research and Ethics Office
Level 3 Arnold Building
5 Arnold Street
Box Hill VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2010

Approval date [1]

11/02/2011

Ethics approval number [1]

E32-1011

Ethics committee name [2]

Epworth HealthCare Human Research Ethics Committee

Ethics committee address [2]

Human Research Ethics Committee Coordinator
Epworth HealthCare
89 Bridge Road
5LP
Richmond VIC 3121

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

30/08/2010

Approval date [2]

15/12/2010

Ethics approval number [2]

50410

Ethics committee name [3]

Peter MacCallum Cancer Centre Ethics Committee

Ethics committee address [3]

Peter MacCallum Cancer Centre Ethics Committee
Peter MacCullum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

30/08/2010

Approval date [3]

11/04/2011

Ethics approval number [3]

10/101

Ethics committee name [4]

Deakin University Human Research Ethics Committee

Ethics committee address [4]

Deakin University Human Research Ethics Committee
Office of Research Integrity, Deakin University
Research Services
221 Burwood Highway
Burwood VIC 3125

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

30/09/2010

Approval date [4]

19/04/2011

Ethics approval number [4]

2011-085

Ethics committee name [5]

Austin Health Human Research Ethics Committee

Ethics committee address [5]

Research Ethics Unit, Henry Buck Building
Austin Hospital
145 Studley Road,
Heidelberg, Vic 3084

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

21/07/2011

Approval date [5]

Ethics approval number [5]

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

Prof Trish Livingston

Address

Deakin University, 221 Burwood HWY, Burwood, 3125, Australia

Country

Australia

Phone

+61392446609

Fax

trish.livingston@deakin.edu.au

Contact person for public queries

Name

Trish Livingston

Address

Faculty of Health, 221 Burwood Highway Burwood VIC 3125

Country

Australia

Phone

+61392446909

Fax

+61392446159

trish.livingston@deakin.edu.au

Contact person for scientific queries

Name

Trish Livingston

Address

Faculty of Health, 221 Burwood Highway Burwood VIC 3125

Country

Australia

Phone

+61392446909

Fax

+61392446159

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

Source	Title	Year of Publication	DOI
Embase	Efficacy of a referral and physical activity program for survivors of prostate cancer [ENGAGE]: Rationale and design for a cluster randomised controlled trial.	2011	https://dx.doi.org/10.1186/1471-2407-11-237
Embase	Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors.	2016	https://dx.doi.org/10.1007/s10552-016-0787-5
Embase	Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study.	2016
Embase	Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial.	2018	https://dx.doi.org/10.1093/abm/kax055

N.B. These documents automatically identified may not have been verified by the study sponsor.

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