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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2611-x

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