TY - JOUR

T1 - Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G)

T2 - a study protocol for a randomised feasibility trial

AU - Pye, Kirstie

AU - Totton, Nicola

AU - Stuart, Nicholas

AU - Whitaker, Rhiannon

AU - Morrison, Val

AU - Edwards, Rhiannon Tudor

AU - Yeo, Seow Tien

AU - Timmis, Laura J

AU - Butterworth, Caryl

AU - Hall, Liz

AU - Rai, Tekendra

AU - Hoare, Zoe

AU - Neal, Richard D

AU - Wilkinson, Clare

AU - Leeson, Simon

PY - 2016/11/23

Y1 - 2016/11/23

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1186/s40814-016-0108-5

DO - 10.1186/s40814-016-0108-5

M3 - Article

C2 - 27965882

VL - 2

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

SN - 2055-5784

M1 - 67

ER -