Spots Global Cancer Trial Database for ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
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Trial Identification
Brief Title: ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
Official Title: 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
Study ID: NCT02413606
Conditions
Interventions
Study Description
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.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Jeroen Bosch, Den Bosch, , Netherlands
Haga hospital, Den Haag, , Netherlands
MC Haaglanden, Den Haag, , 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
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
Contact Details
Name: Lonneke van de Poll-Franse, PhD
Affiliation: Comprehensive Cancer Centre The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Roy Kruitwagen, PhD
Affiliation: Maastricht University Medical Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Carien Creutzberg, PhD
Affiliation: Leiden University Medical Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Nicole Ezendam, PhD
Affiliation: Comprehensive Cancer Centre The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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