ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
ENSURE
1 other identifier
interventional
319
1 country
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 10, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedDecember 6, 2023
December 1, 2023
6.5 years
March 24, 2015
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient satisfaction with follow-up care
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
Cost-effectiveness from the health care perspective using the EQ-5D
assessed at 60 months after completion of primary treatment
Secondary Outcomes (19)
Costs-effectiveness
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
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
assessed at 6, 12, 36, and 60 months after completion of primary treatment
Health-Related Quality of Live
assessed at baseline, 6, 12, and 36 months after completion of primary treatment
Health-Related Quality of Live
assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
- +14 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALreduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
control
NO INTERVENTIONregular follow-up schedule according to the guideline, 10-13 visits during 5 years
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- Written informed consent;
- Sufficient oral and written command of the Dutch language.
You may not qualify if:
- Any other stage and type of endometrial carcinoma
- Histological types papillary serous carcinoma or clear cell carcinoma
- Uterine sarcoma (including carcinosarcoma)
- Radiotherapy for current endometrial carcinoma
- Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
- Confirmed Lynch syndrome
- Previous pelvic radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Comprehensive Cancer Centre The Netherlandslead
- Dutch Cancer Societycollaborator
- Maastricht University Medical Centercollaborator
- Leiden University Medical Centercollaborator
Study Sites (47)
Jeroen Bosch
's-Hertogenbosch, Netherlands
Noordwest ziekhuisgroep
Alkmaar, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Amstelland Ziekenuis
Amstelveen, Netherlands
AMC
Amsterdam, Netherlands
AVL
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Bravis
Bergen op Zoom, Netherlands
Tergooi
Blaricum, Netherlands
Amphia
Breda, Netherlands
Reinier de Graaf Hospital
Delft, Netherlands
Deventer Hospital
Deventer, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Groene Hart
Gouda, Netherlands
Martini Hospital
Groningen, Netherlands
UMC Groningen
Groningen, Netherlands
Röpcke-Zweers Ziekenhuis
Hardenberg, Netherlands
Tjongerschans
Heerenveen, Netherlands
Zuyderland Hospital
Heerlerheide, Netherlands
Westfries Gasthuis
Hoorn, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Alrijne Ziekenhuis
Leiden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
St. Antonius
Nieuwegein, Netherlands
Waterland Ziekenhuis
Purmerend, Netherlands
Bravis
Roosendaal, Netherlands
Franciscus Gasthuis
Rotterdam, Netherlands
Vlietland
Schiedam, Netherlands
Zuyderland
Sittard, Netherlands
Refaja
Stadskanaal, Netherlands
Haga hospital
The Hague, Netherlands
MC Haaglanden
The Hague, Netherlands
Elisabeth TweeSteden, TweeSteden
Tilburg, Netherlands
Elisabeth-TweeSteden
Tilburg, Netherlands
Bernhoven
Uden, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
VieCuri
Venlo, Netherlands
Streekziekenhuis Koningin Beatrix
Winterswijk, Netherlands
Zuwe Hofpoort
Woerden, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands
Langeland
Zoetermeer, Netherlands
Gelre Ziekenhuizen
Zutphen, Netherlands
Isala kliniek
Zwolle, Netherlands
Related Publications (1)
Ezendam NPM, de Rooij BH, Kruitwagen RFPM, Creutzberg CL, van Loon I, Boll D, Vos MC, van de Poll-Franse LV. 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.
PMID: 29661218DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 10, 2015
Study Start
September 1, 2015
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
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