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

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, 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

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.

Keywords: Cost-effectiveness; Endometrial cancer; Follow-up care; Patient-initiated; Patient-reported outcomes; Randomized controlled trial; Reduced follow-up; Satisfaction with care.

Conflict of interest statement

Ethics approval and consent to participate

Medical Ethics approval has been obtained by the Brabant Medical Ethics Committee (MEC) before the start of this project (no. 2015.011). A local research declaration has been obtained for each participating hospital. The study will be conducted in full conformation with the ethical principles of the Declaration of Helsinki Seoul, 2008 and Dutch laws. Informed consent will be asked by the treating gynecologist during the postoperative visit. The patient is provided information about the study and an informed consent form. Patients have at least two weeks to consider the proposal. After the patient provides informed consent, the patient completes the informed consent form, which is filed in the hospital.

Consent for publication

Informed consent includes consent for publication.

Competing interests

The authors declare that they have no competing interests. The study funders did not/ will not have any role in the design of the study; collection, management, analysis, and interpretation of data; writing of manuscripts; and the decision to submit the manuscripts for publication.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
SPIRIT checklist: schedule of enrolment, interventions, and assessments

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