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Thursday, December 15, 2016

North Wales: Trial of Optimal Personalised Care After Treatment for Gyn cancer

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial | Pilot and Feasibility Studies | Full Text

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.


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


Aims of follow-up

The aims of follow-up care include the management of patients’ physical and psychological morbidity and the prevention or early detection of local recurrence, distant metastases or appearance of second cancers [8, 9]. Follow-up care is routine for women who have completed treatment for gynaecological cancer but is not evidence-based. Currently, there is no agreement as to what follow-up care is effective, and there are no guidelines from The National Institute for Health and Care Excellence (NICE) as to what form or frequency of follow-up is appropriate after treatment for gynaecological cancer.


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