title: Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.
abstract: BACKGROUND
  Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment.
  
  
  METHODS
  The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation.
  
  
  CONCLUSIONS
  The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention.
  
  
  BACKGROUND
  ISRCTN45565436.
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Kirstie
authors.initials: K
authors.lastname: Pye
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Totton
authors.affiliation: Betsi Cadwaladr University Health Board, Bangor, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Stuart
authors.affiliation: Whitaker Research Ltd., Bangor, UK.
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Whitaker
authors.affiliation: School of Psychology, COHABS, Bangor University, Bangor, UK.
authors.forename: Val
authors.initials: V
authors.lastname: Morrison
authors.affiliation: Centre for Health Economics and Medicines Evaluation, IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Centre for Health Economics and Medicines Evaluation, IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Seow Tien
authors.initials: ST
authors.lastname: Yeo
authors.affiliation: Centre for Health Economics and Medicines Evaluation, IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Timmis
authors.affiliation: Betsi Cadwaladr University Health Board, Bangor, UK.
authors.forename: Caryl
authors.initials: C
authors.lastname: Butterworth
authors.affiliation: Betsi Cadwaladr University Health Board, Bangor, UK.
authors.forename: Liz
authors.initials: L
authors.lastname: Hall
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Tekendra
authors.initials: T
authors.lastname: Rai
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
authors.forename: Richard D
authors.initials: RD
authors.lastname: Neal
authors.affiliation: North Wales Centre for Primary Care Research, COHABS, Bangor University, Bangor, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Wilkinson
authors.affiliation: Betsi Cadwaladr University Health Board, Bangor, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Leeson
keywords: Feasibility; Gynaecological cancer follow-up; Nurse-led telephone intervention; Quality of life; Randomised controlled trial