Trial of Optimal Personalised Care After Treatment for Gynaecological Cancer (TOPCAT-G): a Study Protocol for a Randomised Feasibility Trial

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2016 Dec 15

PMID 27965882

Citations 1

Authors

Kirstie Pye

Nicola Totton

Nicholas Stuart

Rhiannon Whitaker

Val Morrison

Rhiannon Tudor Edwards

Seow Tien Yeo

Laura J Timmis

Caryl Butterworth

Liz Hall

Tekendra Rai

Zoe Hoare

Richard D Neal

Clare Wilkinson

Simon Leeson

Affiliations

Soon will be listed here.

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.

Citing Articles

Follow-up strategies following completion of primary cancer treatment in adult cancer survivors.

L Hoeg B, Bidstrup P, Karlsen R, Friberg A, Albieri V, Dalton S Cochrane Database Syst Rev. 2019; 2019(11).

PMID: 31750936 PMC: 6870787. DOI: 10.1002/14651858.CD012425.pub2.

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