Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial

Affiliations

¹ North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
² Betsi Cadwaladr University Health Board, Bangor, UK.
³ Whitaker Research Ltd., Bangor, UK.
⁴ School of Psychology, COHABS, Bangor University, Bangor, UK.
⁵ Centre for Health Economics and Medicines Evaluation, IMSCaR, COHABS, Bangor University, Bangor, UK.
⁶ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
⁷ North Wales Centre for Primary Care Research, COHABS, Bangor University, Bangor, UK.

PMID: 27965882
PMCID: PMC5154014
DOI: 10.1186/s40814-016-0108-5

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial

Kirstie Pye et al. Pilot Feasibility Stud. 2016.

. 2016 Nov 23:2:67.

doi: 10.1186/s40814-016-0108-5. eCollection 2016.

Authors

Affiliations

¹ North Wales Organisation for Randomised Trials in Health (NWORTH), IMSCaR, COHABS, Bangor University, Bangor, UK.
² Betsi Cadwaladr University Health Board, Bangor, UK.
³ Whitaker Research Ltd., Bangor, UK.
⁴ School of Psychology, COHABS, Bangor University, Bangor, UK.
⁵ Centre for Health Economics and Medicines Evaluation, IMSCaR, COHABS, Bangor University, Bangor, UK.
⁶ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
⁷ North Wales Centre for Primary Care Research, COHABS, Bangor University, Bangor, UK.

PMID: 27965882
PMCID: PMC5154014
DOI: 10.1186/s40814-016-0108-5

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.

Discussion: 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.

Trial registration: ISRCTN45565436.

Keywords: Feasibility; Gynaecological cancer follow-up; Nurse-led telephone intervention; Quality of life; Randomised controlled trial.

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