Dataset Information

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer.

ABSTRACT:

Introduction

Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer.

Methods and analysis

The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial.

Ethics and dissemination

Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria.

Results

of this phase II trial will be reported in peer-reviewed publications and in conference presentations.

Trial registration

Australian New Zealand Clinical Trial Registry ACTRN12610000938000.

SUBMITTER: Emery J

PROVIDER: S-EPMC3948582 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Publications

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer.

Emery Jon J Doorey Juanita J Jefford Michael M King Madeleine M Pirotta Marie M Hayne Dickon D Martin Andrew A Trevena Lyndal L Lim Tee T Constable Roger R Hawks Cynthia C Hyatt Amelia A Hamid Akhlil A Violet John J Gill Suki S Frydenberg Mark M Schofield Penelope P

BMJ open 20140306 3

<h4>Introduction</h4>Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer.<h4>Methods and ana ...[more]

PMID: 24604487

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Dataset Information

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer.

Introduction

Methods and analysis

Ethics and dissemination

Results

Trial registration

Publications

Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer.

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