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

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 227
• Main Authors: Ezendam, Nicole P M, de Rooij, Belle H, Kruitwagen, Roy F P M, Creutzberg, Carien L, van Loon, Ingrid, Boll, Dorry, Vos, M Caroline, van de Poll-Franse, Lonneke V
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 16.04.2018; BioMed Central; BMC
• Subjects: Aftercare - economics; Aftercare - standards; Appointments and Schedules; Cancer therapies; Clinical outcomes; Clinical trials; Comparative analysis; Cost analysis; Cost reduction; Cost Savings; Cost-Benefit Analysis; Economic aspects; Endometrial cancer; Endometrial Neoplasms - economics; Endometrial Neoplasms - pathology; Endometrial Neoplasms - psychology; Endometrial Neoplasms - therapy; Equivalence Trials as Topic; Female; Follow-up care; Gynecology; Health aspects; Health Care Costs; Humans; Informed consent; Intervention; Medical care quality; Multicenter Studies as Topic; Neoplasm Staging; Netherlands; Patient outcomes; Patient satisfaction; Patient Satisfaction - economics; Patient-initiated; Patient-reported outcomes; Practice Guidelines as Topic; Questionnaires; Radiation therapy; Randomized controlled trial; Reduced follow-up; Schedules; Study Protocol; Surgery; Surveys and Questionnaires; Time Factors; Treatment Outcome; Netherlands; Reduced follow-up; Endometrial cancer; Patient-initiated; Patient-reported outcomes; Satisfaction with care; Cost-effectiveness; Follow-up care; Randomized controlled trial
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2611-x

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