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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Endometrial Neoplasms
Cost-Benefit Analysis
Survivors
Netherlands
Adjuvant Radiotherapy
Quality-Adjusted Life Years
Linear Models
Depression
Delivery of Health Care

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

Cite this

@article{3b07d9f120e14bbd9e0648f392099ab7,
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.",
abstract = "BackgroundIt 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.MethodsIn 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.DiscussionWe 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.",
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",
author = "N.P.M. Ezendam and {de Rooij}, B.H. and R.F.P.M. Kruitwagen and C.L. Creutzberg and {van Loon}, I. and D. Boll and M.C. Vos and {van de Poll-Franse}, L.V.",
year = "2018",
doi = "10.1186/s13063-018-2611-x",
language = "English",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

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

In: Trials, Vol. 19, No. 1, 227, 2018.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule

T2 - Study protocol of a randomized controlled trial.

AU - Ezendam, N.P.M.

AU - de Rooij, B.H.

AU - Kruitwagen, R.F.P.M.

AU - Creutzberg, C.L.

AU - van Loon, I.

AU - Boll, D.

AU - Vos, M.C.

AU - van de Poll-Franse, L.V.

PY - 2018

Y1 - 2018

N2 - BackgroundIt 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.MethodsIn 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.DiscussionWe 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.

AB - BackgroundIt 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.MethodsIn 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.DiscussionWe 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.

KW - BREAST-CANCER

KW - COLORECTAL-CANCER

KW - Cost-effectiveness

KW - DEPRESSION SCALE

KW - EUROPEAN-ORGANIZATION

KW - Endometrial cancer

KW - Follow-up care

KW - GYNECOLOGICAL CANCER

KW - HOSPITAL ANXIETY

KW - OVARIAN-CANCER

KW - Patient-initiated

KW - Patient-reported outcomes

KW - QUALITY-OF-LIFE

KW - QUESTIONNAIRE

KW - REPORTED OUTCOMES

KW - Randomized controlled trial

KW - Reduced follow-up

KW - Satisfaction with care

U2 - 10.1186/s13063-018-2611-x

DO - 10.1186/s13063-018-2611-x

M3 - Article

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 227

ER -