ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? (ENSURE)

December 5, 2023 updated by: Nicole Ezendam, Comprehensive Cancer Centre The Netherlands

ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule

Background: It has often been hypothesized that the frequency of follow-up 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.

Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).

Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.

Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival

Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated

Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.

Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

319

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lonneke van de Poll-Franse, PhD
  • Phone Number: +31 88 2346273
  • Email: l.vandepoll@iknl.nl

Study Locations

      • Alkmaar, Netherlands
        • Noordwest ziekhuisgroep
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Amstelveen, Netherlands
        • Amstelland Ziekenuis
      • Amsterdam, Netherlands
        • AMC
      • Amsterdam, Netherlands
        • OLVG
      • Amsterdam, Netherlands
        • AVL
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuizen
      • Bergen op Zoom, Netherlands
        • Bravis
      • Blaricum, Netherlands
        • Tergooi
      • Breda, Netherlands
        • Amphia
      • Delft, Netherlands
        • Reinier de Graaf Hospital
      • Den Bosch, Netherlands
        • Jeroen Bosch
      • Den Haag, Netherlands
        • MC Haaglanden
      • Den Haag, Netherlands
        • Haga Hospital
      • Deventer, Netherlands
        • Deventer Hospital
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Enschede, Netherlands
        • Medical Spectrum Twente
      • Gouda, Netherlands
        • Groene Hart
      • Groningen, Netherlands
        • UMC Groningen
      • Groningen, Netherlands
        • Martini Hospital
      • Hardenberg, Netherlands
        • Ropcke-Zweers Ziekenhuis
      • Heerenveen, Netherlands
        • Tjongerschans
      • Heerlerheide, Netherlands
        • Zuyderland Hospital
      • Hoorn, Netherlands
        • Westfries Gasthuis
      • Leeuwarden, Netherlands
        • Medical Center Leeuwarden
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Leiden, Netherlands
        • Alrijne Ziekenhuis
      • Maastricht, Netherlands
        • Maastricht University Medical Center
      • Nieuwegein, Netherlands
        • St. Antonius
      • Purmerend, Netherlands
        • Waterland Ziekenhuis
      • Roosendaal, Netherlands
        • Bravis
      • Rotterdam, Netherlands
        • Franciscus Gasthuis
      • Schiedam, Netherlands
        • Vlietland
      • Sittard, Netherlands
        • Zuyderland
      • Stadskanaal, Netherlands
        • Refaja
      • Tilburg, Netherlands
        • Elisabeth-TweeSteden
      • Tilburg, Netherlands
        • Elisabeth TweeSteden, TweeSteden
      • Uden, Netherlands
        • Bernhoven
      • Veldhoven, Netherlands
        • Maxima Medisch Centrum
      • Venlo, Netherlands
        • VieCuri
      • Winterswijk, Netherlands
        • Streekziekenhuis Koningin Beatrix
      • Woerden, Netherlands
        • Zuwe Hofpoort
      • Zaandam, Netherlands
        • Zaans Medisch Centrum
      • Zoetermeer, Netherlands
        • Langeland
      • Zutphen, Netherlands
        • Gelre Ziekenhuizen
      • Zwolle, Netherlands
        • Isala Kliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with Endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:

    Stage 1A, any age, grade 1 or 2; Stage 1B, < 60 years, grade 1 or 2 without LVSI;

  2. Written informed consent;
  3. Sufficient oral and written command of the Dutch language.

Exclusion Criteria:

  1. Any other stage and type of endometrial carcinoma
  2. Histological types papillary serous carcinoma or clear cell carcinoma
  3. Uterine sarcoma (including carcinosarcoma)
  4. Radiotherapy for current endometrial carcinoma
  5. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
  6. Confirmed Lynch syndrome
  7. Previous pelvic radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
In the intervention group, the follow-up schedule will be limited to four follow-up visits at 3, 12, 24 and 36 months, under the specific condition that patients have easy and prompt access to care (specialised nurse of gynaecologist) if symptoms or questions occur. The content of the follow-up visits will be similar for both groups.
No Intervention: control
regular follow-up schedule according to the guideline, 10-13 visits during 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with follow-up care
Time Frame: up to 60 months after completion of primary treatment
assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points
up to 60 months after completion of primary treatment
Costs-effectiveness
Time Frame: assessed at 60 months after completion of primary treatment
Cost-effectiveness from the health care perspective using the EQ-5D
assessed at 60 months after completion of primary treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs-effectiveness
Time Frame: assessed at 36 months after completion of primary treatment
Cost-effectiveness from the health care perspective using the EQ-5D
assessed at 36 months after completion of primary treatment
Health care use -gynaecologist, (specialist) nurse, primary care physician and other health or care services-; adherence to the indicated follow-up protocols; reasons for non-adherence
Time Frame: assessed at 6, 12 and 36 months after completion of primary treatment
health care use is assessed from hospital charges, primary care physician and self-report; analysed with a repeated mixed model as one overall outcome over all time points
assessed at 6, 12 and 36 months after completion of primary treatment
Health care use -gynaecologist, (specialist) nurse, primary care physician and other health or care services-; adherence to the indicated follow-up protocols; reasons for non-adherence
Time Frame: assessed at 6, 12, 36, and 60 months after completion of primary treatment
health care use is assessed from hospital charges, primary care physician and self-report; analysed with a repeated mixed model as one overall outcome over all time points
assessed at 6, 12, 36, and 60 months after completion of primary treatment
Health-Related Quality of Live
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Health-Related Quality of Live
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Worry including fear of recurrence
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Worry including fear of recurrence
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Illness perceptions
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Illness perceptions
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Anxiety and depression
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Anxiety and depression
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Satisfaction with information provision
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Satisfaction with information provision
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
Time Frame: assessed at 36 months after completion of primary treatment
assessed with structured interviews/questionnaires
assessed at 36 months after completion of primary treatment
Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
Time Frame: assessed at 60 months after completion of primary treatment
assessed with structured interviews/questionnaires
assessed at 60 months after completion of primary treatment
Time till recurrence
Time Frame: assessed at 36 months after completion of primary treatment
In this study we will descriptively look at time till recurrence
assessed at 36 months after completion of primary treatment
Time till recurrence
Time Frame: assessed at 60 months after completion of primary treatment
In this study we will descriptively look at time till recurrence
assessed at 60 months after completion of primary treatment
Survival
Time Frame: assessed at 36 months after completion of primary treatment
descriptively look at survival
assessed at 36 months after completion of primary treatment
Survival
Time Frame: assessed at 60 months after completion of primary treatment
descriptively look at survival
assessed at 60 months after completion of primary treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lonneke van de Poll-Franse, PhD, Comprehensive Cancer Centre The Netherlands
  • Principal Investigator: Roy Kruitwagen, PhD, Maastricht University Medical Centre
  • Principal Investigator: Carien Creutzberg, PhD, Leiden University Medical Centre
  • Principal Investigator: Nicole Ezendam, PhD, Comprehensive Cancer Centre The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimated)

April 10, 2015

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After ending the study and analysis of the data, data becomes available for use by other researchers via PROFILES registry, according to the their terms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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