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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

ENdometrial cancer SURvivors’ follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Nicole P. M. Ezendam, Belle H. de Rooij, Roy F. P. M. Kruitwagen, Carien L. Creutzberg, Ingrid van Loon, Dorry Boll, M. Caroline Vos, Lonneke V. van de Poll-Franse
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2611-x) contains supplementary material, which is available to authorized users.

Abstract

Background

It has often been hypothesized that the frequency of follow-up visits for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking. The aim of this study is to assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Methods

In this multicenter randomized controlled trial, patients diagnosed in the Netherlands with stage 1A and 1B low-risk endometrial cancer, for whom adjuvant radiotherapy is not indicated (n = 282), are randomized. Patients allocated to the intervention group receive four follow-up visits during three years. Patients allocated to the control group receive 10–13 follow-up visits during five years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline and after 6, 12, 36, and 60 months. Primary outcomes include patient satisfaction with follow-up care and cost-effectiveness. Secondary outcomes include healthcare use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, and survival. Linear regression analyses will be used to assess differences in patient satisfaction with follow-up care between intervention and control group.

Discussion

We anticipate that patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower healthcare use and costs than patients in the control arm. No differences are expected in quality-adjusted life-years and satisfaction, but the reduced schedule is expected to be cost-saving when implemented in the Netherlands.

Trial registration

ClinicalTrials.gov, NCT02413606. Registered on 10 April 2015.
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