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

Trials. 2018 Apr 16;19(1):227. doi: 10.1186/s13063-018-2611-x.


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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aftercare / economics*
  • Aftercare / standards
  • Appointments and Schedules*
  • Cost Savings
  • Cost-Benefit Analysis
  • Endometrial Neoplasms / economics*
  • Endometrial Neoplasms / pathology
  • Endometrial Neoplasms / psychology
  • Endometrial Neoplasms / therapy*
  • Equivalence Trials as Topic
  • Female
  • Health Care Costs*
  • Humans
  • Multicenter Studies as Topic
  • Neoplasm Staging
  • Netherlands
  • Patient Satisfaction / economics*
  • Practice Guidelines as Topic
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02413606