Article Text

A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol
  1. Marian Andrei Stanciu1,
  2. Caroline Morris2,
  3. Matt Makin2,
  4. Eila Watson3,
  5. Jenna Bulger1,
  6. Richard Evans1,
  7. Julia Hiscock1,
  8. Zoë Hoare4,
  9. Rhiannon Tudor Edwards5,
  10. Richard David Neal1,
  11. Clare Wilkinson1
  1. 1North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK
  2. 2Betsi Cadwaladr University Health Board, Wrexham, UK
  3. 3Department of Clinical Health Care, Oxford Brookes University, Oxford, UK
  4. 4North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK
  5. 5Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK
  1. Correspondence to Marian Andrei Stanciu; a.stanciu{at}bangor.ac.uk

Abstract

Introduction Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings.

Methods and analysis Prostate cancer survivors diagnosed in the past 9–48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation.

Ethics and dissemination Ethics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific conferences, and directly through national cancer and primary care networks.

Trial registration number ISRCTN 34516019.

  • PRIMARY CARE
  • UROLOGY
  • Needs Assessment

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/

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