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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
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
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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