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Oncology
Protocol
Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer
  1. Allan Ben Smith1,2,
  2. Pascal Mancuso2,3,
  3. Mark Sidhom2,4,
  4. Karen Wong2,4,
  5. Megan Berry2,4,
  6. Orlando Rincones1,
  7. Dion Forstner4,5,
  8. Lesley Bokey1,6,
  9. Afaf Girgis1,2
  1. 1 Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research & University of New South Wales, Liverpool, New South Wales, Australia
  2. 2 South Western Sydney Clinical School, University of New South Wales, Liverpool, New South Wales, Australia
  3. 3 Department of Urological Surgery, Liverpool Hospital, South Western Sydney Local Health District, Liverpool, New South Wales, Australia
  4. 4 Liverpool Cancer Therapy Centre, Liverpool Hospital, South Western Sydney Local Health District, Liverpool, New South Wales, Australia
  5. 5 School of Medicine, Western Sydney University, Penrith South DC, New South Wales, Australia
  6. 6 Division of Surgery, Liverpool Hospital, South Western Sydney Local Health District, Liverpool, New South Wales, Australia
  1. Correspondence to Dr Allan Ben Smith; ben.smith{at}unsw.edu.au

Abstract

Background Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy.

Methods and analysis This study will be conducted at a large public teaching hospital in Australia offering the choice between robotic prostatectomy and radiotherapy from early 2017. Men (20–30) diagnosed with LPC who want curative treatment and meet criteria for either treatment will be invited to participate. In this mixed-methods study, patients will complete semistructured interviews before and after attending a combined clinic in which they consult a urologist and a radiation oncologist regarding treatment and four questionnaires (one before treatment decision-making and three after) assessing demographic and clinical characteristics, involvement in decision-making, decisional conflict, satisfaction and regret. Combined clinic consultations will also be audio-recorded and clinicians will report their perceptions regarding patients’ suitability for, openness to and preferences for each treatment. Qualitative data will be transcribed verbatim and thematically analysed and descriptive statistical analyses will explore quantitative decision-making outcomes, with comparison according to treatment choice.

Discussion Results from this study will inform how to best support men diagnosed with LPC deciding which curative treatment option best suits their needs and may identify the need for and content required in a decision aid to support these men.

Ethics and dissemination All participants will provide written informed consent. Data will be rigorously managed in accordance with national legislation. Results will be disseminated via presentations to both scientific and layperson audiences and publications in peer-reviewed scientific journals.

  • oncology
  • urological tumours
  • radiation oncology
  • shared decision-making
  • mixed methods
  • robotic prostatectomy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) 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/4.0/

https://doi.org/10.1136/bmjopen-2017-018403

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    Footnotes

    • Contributors All authors contributed to the initial conception and design of the study. AG and DF were instrumental in securing funding for the project. ABS led the development of the initial study protocol, which AG, PM, DF and LB reviewed and provided feedback on. ABS, OR and AG drafted the protocol manuscript and all other authors (PM, MS, KW, MB, DF, LB) gave critical feedback. All authors read and approved the final version of the manuscript and agree to be accountable for all aspects of the work. ABS drafted the response to reviewers comments with feedback from PM, MS, KW, MB, OR, DF, LB, AG, who all read and approved the resubmitted version of the manuscript.

    • Funding ABS and AG are funded through a Cancer Institute New South Wales grant. This research was internally funded by South Western Sydney Local Health District, which has no influence on the interpretation of funding or publication of the results. This research received no specific grant from any funding agency in the public, commercial or not-for-profit sector.

    • Competing interests None declared.

    • Ethics approval South Western Sydney Local Health District Human Research Ethics Committee (HREC/16/LPOOL/652).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Anyone may contact the investigators to request access to the aggregate qualitative data generated by this study. None other than the principal investigator and his team, all of whom have signed a confidentiality agreement, will have access to the audio recordings and transcripts of the interviews.