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Oncology
Protocol
Protocol for the ProCare Trial: a phase II randomised controlled trial of shared care for follow-up of men with prostate cancer
  1. Jon Emery1,2,
  2. Juanita Doorey2,
  3. Michael Jefford3,
  4. Madeleine King4,
  5. Marie Pirotta1,
  6. Dickon Hayne5,6,
  7. Andrew Martin7,
  8. Lyndal Trevena8,
  9. Tee Lim9,
  10. Roger Constable10,
  11. Cynthia Hawks6,
  12. Amelia Hyatt11,
  13. Akhlil Hamid12,
  14. John Violet13,
  15. Suki Gill13,
  16. Mark Frydenberg14,
  17. Penelope Schofield11
  1. 1General Practice and Primary Health Care Academic Centre, The University of Melbourne, Carlton, Victoria, Australia
  2. 2Department of General Practice, School of Primary, Aboriginal and Rural Health Care, The University of Western Australia, Perth, Western Australia, Australia
  3. 3Department of Medical Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
  4. 4Psycho-oncology Co-operative Research Group (PoCoG), School of Psychology, The University of Sydney, Sydney, New South Wales, Australia
  5. 5School of Surgery, The University of Western Australia, Western Australia, Australia
  6. 6Urology Department, Fremantle Hospital, Fremantle, Western Australia, Australia
  7. 7NHMRC Clinical Trials Centre, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
  8. 8School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  9. 9Genesis Cancer Care, Royal Perth Hospital, Perth, Western Australia, Australia
  10. 10Prostate Cancer Foundation of Australia, Perth, Western Australia, Australia
  11. 11Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
  12. 12Urology Department, Royal Perth Hospital, Perth, Western Australia, Australia
  13. 13Department of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
  14. 14Department of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
  1. Correspondence to Professor Jon Emery; jon.emery{at}unimelb.edu.au

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

  • Primary Care

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjopen-2014-004972

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