ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
NCT ID: NCT02413606
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
319 participants
INTERVENTIONAL
2015-09-30
2022-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention
reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
Reduced follow-up schedule
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.
control
regular follow-up schedule according to the guideline, 10-13 visits during 5 years
No interventions assigned to this group
Interventions
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Reduced follow-up schedule
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
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Inclusion Criteria
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
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
FEMALE
No
Sponsors
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Dutch Cancer Society
OTHER
Maastricht University Medical Center
OTHER
Leiden University Medical Center
OTHER
Comprehensive Cancer Centre The Netherlands
OTHER
Responsible Party
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Nicole Ezendam
Dr.
Principal Investigators
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Lonneke van de Poll-Franse, PhD
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Cancer Centre The Netherlands
Roy Kruitwagen, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Carien Creutzberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Nicole Ezendam, PhD
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Cancer Centre The Netherlands
Locations
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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
Countries
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References
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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.
Other Identifiers
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IKZ 2014-6677
Identifier Type: -
Identifier Source: org_study_id