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Trial registered on ANZCTR


Registration number
ACTRN12610000938000
Ethics application status
Approved
Date submitted
1/11/2010
Date registered
4/11/2010
Date last updated
1/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The ProCare Trial: A randomised controlled trial of follow up of men with prostate cancer in primary care.
Scientific title
'A Phase II randomised controlled trial of follow up of men with prostate cancer in primary care, to assess the acceptability and feasiblity of a shared care model'
Secondary ID [1] 252986 0
Nil
Universal Trial Number (UTN)
U1111-1117-4400
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 258434 0
Condition category
Condition code
Cancer 258683 258683 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study seeks to develop and test a model of shared care follow-up for men with prostate cancer that aims to reduce psychological distress and unmet needs. Participants will be randomised to receive either usual care (in accordance with local hospital practice) or Trial shared-care (the intervention arm) for routine follow-up of prostate cancer for a period of 12 months. Those in the usual care (CONTROL) arm will have hospital follow-up visits at 6 weeks (radiotherapy treatment group only), 3 months, 6 months, 9 months, and 12 months following the completion of surgery and / or radiotherapy. Those in the Trial shared-care (INTERVENTION) arm will attend hospital follow-up visits at 6 weeks (radiotherapy treatment group only), 3 months, and 12 months and GP visits at 2 weeks, 6 months and 9 months following completion of surgery and / or radiotherapy. That is, two of the routine hospital visits will be replaced by GP visits and an additional GP visit at 2 weeks post-randomisation is also included to discuss the patient care plan and to establish common group about the model of shared care. PSA testing and physical examination (digital rectal examination, DRE) will be completed at the 3, 6, 9 and 12 month visits in both arms.
Intervention code [1] 257506 0
Treatment: Other
Intervention code [2] 257507 0
Rehabilitation
Intervention code [3] 257508 0
Behaviour
Comparator / control treatment
The control group will be participants randomised to receive usual care for follow-up for prostate cancer, in accordance with local hospital practice.
Control group
Active

Outcomes
Primary outcome [1] 259538 0
Primary Outcome 1: Trial feasibility as measured by patient recruitment and attrition rates, GP recruitment rates, and response rates to outcome measures
Timepoint [1] 259538 0
At two years after commencement of the Trial.
Primary outcome [2] 259539 0
Primary Outcome 2: Assessment of psychological distress as measured using the Hospital Anxiety and Depression Scale (HADS) mean scores.
Timepoint [2] 259539 0
At baseline, and then at 3 months, 6 months and 12 months
Primary outcome [3] 259540 0
Primary Outcome 3: Assessment of health-related quality of life as measured using mean scores for:

The Cancer Survivors' Unmet Needs measure (CaSUN)
The Expanded Prostate Cancer Index Composite (EPIC)
The Short-form Patient Satisfaction Questionnaire (PSQ-18)
Timepoint [3] 259540 0
At baseline, and then at 3 months, 6 months and 12 months
Secondary outcome [1] 266153 0
Secondary Outcome 1: Prostate cancer recurrence rates and detection, as assessed by use of PSA according to protocol based on Medical Benefits Schedule (MBS) pathology data.
Timepoint [1] 266153 0
From date of randomisation to 2 months after the 12-month follow-up visit.
Secondary outcome [2] 266154 0
Secondary Outcome 2: Incidence of depression, as assessed by PSA data for antidepressants and MBS data on clinical data on clinical psychologists' referrals.
Timepoint [2] 266154 0
From date of randomisation to 2 months after the 12-month follow-up visit.

Eligibility
Key inclusion criteria
1. Pathologically confirmed diagnosis of prostate cancer.
2. Completed surgery and / or radiotherapy with curative intention within 3 weeks of study entry
3. Able to read and write English at a level sufficient to give informed consent and complete study procedures including written questionnaires without an interpreter.
4. Have a general practitioner who agrees to participate in the Trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suspicion or evidence of metatastic disease
2. Severe psychiatric or cognitive disorder, which in the opinion of the investigator would compromise participation in the study.
3. Treatment with palliative intent.
4. No general practitioner.
5. Patients with a pathologically confirmed diagnosis of prostate cancer with any of the following high risk features (cT3; PSA greater than 20; or Gleason score greater than or equal to 8)
6. Patients having androgen deprivation therapy following radiotherapy, irrespective or risk level

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 randomisation using tele-randomisation (Interactive Voice Response System, IVRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by tele-randomisation (Interactive Voice Response System, IVRS) using sequence generation.
Stratification by treatment type (surgery and / or radiotherapy) and site
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
16/11/2012
Date of last participant enrolment
Anticipated
28/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
188
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 526 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 527 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 528 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 529 0
Cabrini Hospital - Malvern - Malvern

Funding & Sponsors
Funding source category [1] 257958 0
Government body
Name [1] 257958 0
National Health and Medical Research Council (NHMRC)
Country [1] 257958 0
Australia
Primary sponsor type
University
Name
Primary Care Collaborative Cancer Clinical Trials Group
Address
General Practice (M706)
School of Primary, Aboriginal and Rural Health Care
The University of Western Australia
35 Stirling Highway
Crawley
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 257191 0
None
Name [1] 257191 0
Address [1] 257191 0
Country [1] 257191 0
Other collaborator category [1] 277271 0
Other Collaborative groups
Name [1] 277271 0
Australian and New Zealand Urogential and Prostate (ANZUP) Cancer Trials Group
Address [1] 277271 0
Level 4, Medical Foundation Building, 92 - 94 Parramatta Road
Camperdown NSW 2050
Locked Bag 77 Camperdown NSW 1450
Country [1] 277271 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259969 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 259969 0
The University of Western Australia
(M501) 35 Stirling Highway
Crawley Western Australia 6009
Ethics committee country [1] 259969 0
Australia
Date submitted for ethics approval [1] 259969 0
22/09/2010
Approval date [1] 259969 0
Ethics approval number [1] 259969 0
RA/4/1/4447
Ethics committee name [2] 259970 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [2] 259970 0
Fremantle Hospital and Health Service
Alma St
Fremantle Western Australia

PO Box 480
Fremantle WA 6959
Ethics committee country [2] 259970 0
Australia
Date submitted for ethics approval [2] 259970 0
19/10/2010
Approval date [2] 259970 0
Ethics approval number [2] 259970 0
10/476
Ethics committee name [3] 286437 0
Royal Perth Hospital Ethics Committee
Ethics committee address [3] 286437 0
Royal Perth Hospital Ethics Office
Room 5105, Level 5, Colonial House
Royal Perth Hospital
Ethics committee country [3] 286437 0
Australia
Date submitted for ethics approval [3] 286437 0
Approval date [3] 286437 0
Ethics approval number [3] 286437 0
RA-11/008
Ethics committee name [4] 288736 0
Peter MacCallum Cancer Centre Victoria
Ethics committee address [4] 288736 0
St Andrews Place East Melbourne Victoria
Locked Bag 1 A'Beckett Street Victoria 8006
Ethics committee country [4] 288736 0
Australia
Date submitted for ethics approval [4] 288736 0
21/11/2011
Approval date [4] 288736 0
01/02/2012
Ethics approval number [4] 288736 0
11/100
Ethics committee name [5] 288737 0
Cabrini Institute
Ethics committee address [5] 288737 0
183 Wattletree Road
Malvern Victoria 3144
Ethics committee country [5] 288737 0
Australia
Date submitted for ethics approval [5] 288737 0
06/12/2012
Approval date [5] 288737 0
10/12/2012
Ethics approval number [5] 288737 0
02-04-02-13

Summary
Brief summary
The primary purpose of this trial is to develop and test a model of shared care follow-up for men with prostate cancer with the aim of reducing unmet needs and psychological distress.

Who is it for?
You may be eligible to join this trial if you are aged 18 years or over and have been diagnosed with prostate cancer for which you have completed surgery and / or radiotherapy with curative intent at Royal Perth Hospital and at Fremantle Hospital in Western Australia, within three weeks of study entry. You will also need to have a GP who agrees to participate in the trial.

Trial details:
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive usual care (in accordance with local hospital practice). Participants in the other group will receive shared care, whereby some of the routine hospital visits are replaced by GP visits over the 12 month follow-up period.

The trial aims to test whether a shared care model of follow-up for prostate cancer may reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care at lower cost compared to usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31794 0
Prof Jon Emery
Address 31794 0
Professor of General Practice
School of Primary, Aboriginal and Rural Health Care
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 31794 0
Australia
Phone 31794 0
+61 8 9346 7502
Fax 31794 0
+61 8 9346 1361
Email 31794 0
[email protected]
Contact person for public queries
Name 15041 0
Juanita Doorey
Address 15041 0
ProCare Trial Coordinator
General Practice M706
School of Primary, Aboriginal and Rural Health Care
The University of Western Australia
35 Stirling Highway
Crawley Western Australia 6009
Country 15041 0
Australia
Phone 15041 0
+61 8 9346 7251
Fax 15041 0
+61 8 9346 1361
Email 15041 0
[email protected]
Contact person for scientific queries
Name 5969 0
Jon Emery
Address 5969 0
Primary Care Collaborative Cancer Clinical Trials Group
General Practice (M706)
The University of Western Australia
35 Stirling Highway
Crawley Western Australia 6009
Country 5969 0
Australia
Phone 5969 0
+61 8 9346 7502
Fax 5969 0
+61 8 9346 1361
Email 5969 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
SourceTitleYear of PublicationDOI
Dimensions AIThe Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group – a new co-operative cancer trials group in genitourinary oncology2015https://doi.org/10.1111/bju.12925
N.B. These documents automatically identified may not have been verified by the study sponsor.