title: 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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN 34516019.
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Marian Andrei
authors.initials: MA
authors.lastname: Stanciu
authors.affiliation: Betsi Cadwaladr University Health Board, Wrexham, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Morris
authors.affiliation: Betsi Cadwaladr University Health Board, Wrexham, UK.
authors.forename: Matt
authors.initials: M
authors.lastname: Makin
authors.affiliation: Department of Clinical Health Care, Oxford Brookes University, Oxford, UK.
authors.forename: Eila
authors.initials: E
authors.lastname: Watson
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Jenna
authors.initials: J
authors.lastname: Bulger
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Evans
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Hiscock
authors.affiliation: North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.
authors.forename: Zoë
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Richard David
authors.initials: RD
authors.lastname: Neal
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Wilkinson
mesh_terms: D000223:Adaptation, Psychological; D000368:Aged; D002985:Clinical Protocols; D005240:Feasibility Studies; D018939:Holistic Nursing; D006801:Humans; D008297:Male; D008875:Middle Aged; D020380:Needs Assessment; D010353:Patient Education as Topic; D010865:Pilot Projects; D057285:Precision Medicine; D011320:Primary Health Care; D011471:Prostatic Neoplasms / Q000451:nursing / Q000523:psychology* / Q000601:surgery; D011788:Quality of Life / Q000523:psychology; D012648:Self Care; D012735:Sexual Dysfunction, Physiological / Q000451:nursing / Q000523:psychology / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000451:nursing / Q000628:therapy*; D017741:Survivors / Q000523:psychology*; D014852:Wales / Q000453:epidemiology
keywords: Needs Assessment; PRIMARY CARE; UROLOGY