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.

N.P.M. Ezendam, B.H. de Rooij, R.F.P.M. Kruitwagen, C.L. Creutzberg, I. van Loon, D. Boll, M.C. Vos, L.V. van de Poll-Franse

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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.
Original languageEnglish
Article number227
Number of pages9
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - 2018

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Keywords

  • BREAST-CANCER
  • COLORECTAL-CANCER
  • Cost-effectiveness
  • DEPRESSION SCALE
  • EUROPEAN-ORGANIZATION
  • Endometrial cancer
  • Follow-up care
  • GYNECOLOGICAL CANCER
  • HOSPITAL ANXIETY
  • OVARIAN-CANCER
  • Patient-initiated
  • Patient-reported outcomes
  • QUALITY-OF-LIFE
  • QUESTIONNAIRE
  • REPORTED OUTCOMES
  • Randomized controlled trial
  • Reduced follow-up
  • Satisfaction with care

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