- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413606
ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? (ENSURE)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Ezendam, PhD
- Phone Number: +31 88 2346096
- Email: n.ezendam@iknl.nl
Study Contact Backup
- Name: Lonneke van de Poll-Franse, PhD
- Phone Number: +31 88 2346273
- Email: l.vandepoll@iknl.nl
Study Locations
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Alkmaar, Netherlands
- Noordwest ziekhuisgroep
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Amersfoort, Netherlands
- Meander Medisch Centrum
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Amstelveen, Netherlands
- Amstelland Ziekenuis
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Amsterdam, Netherlands
- AMC
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Amsterdam, Netherlands
- OLVG
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Amsterdam, Netherlands
- AVL
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Apeldoorn, Netherlands
- Gelre Ziekenhuizen
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Bergen op Zoom, Netherlands
- Bravis
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Blaricum, Netherlands
- Tergooi
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Breda, Netherlands
- Amphia
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Delft, Netherlands
- Reinier de Graaf Hospital
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Den Bosch, Netherlands
- Jeroen Bosch
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Den Haag, Netherlands
- MC Haaglanden
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Den Haag, Netherlands
- Haga Hospital
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Deventer, Netherlands
- Deventer Hospital
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Dordrecht, Netherlands
- Albert Schweitzer Ziekenhuis
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Eindhoven, Netherlands
- Catharina Hospital
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Enschede, Netherlands
- Medical Spectrum Twente
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Gouda, Netherlands
- Groene Hart
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Groningen, Netherlands
- UMC Groningen
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Groningen, Netherlands
- Martini Hospital
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Hardenberg, Netherlands
- Ropcke-Zweers Ziekenhuis
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Heerenveen, Netherlands
- Tjongerschans
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Heerlerheide, Netherlands
- Zuyderland Hospital
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Hoorn, Netherlands
- Westfries Gasthuis
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Leeuwarden, Netherlands
- Medical Center Leeuwarden
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Leiden, Netherlands
- Leiden University Medical Center
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Leiden, Netherlands
- Alrijne Ziekenhuis
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Maastricht, Netherlands
- Maastricht University Medical Center
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Nieuwegein, Netherlands
- St. Antonius
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Purmerend, Netherlands
- Waterland Ziekenhuis
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Roosendaal, Netherlands
- Bravis
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Rotterdam, Netherlands
- Franciscus Gasthuis
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Schiedam, Netherlands
- Vlietland
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Sittard, Netherlands
- Zuyderland
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Stadskanaal, Netherlands
- Refaja
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Tilburg, Netherlands
- Elisabeth-TweeSteden
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Tilburg, Netherlands
- Elisabeth TweeSteden, TweeSteden
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Uden, Netherlands
- Bernhoven
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Veldhoven, Netherlands
- Maxima Medisch Centrum
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Venlo, Netherlands
- VieCuri
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Winterswijk, Netherlands
- Streekziekenhuis Koningin Beatrix
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Woerden, Netherlands
- Zuwe Hofpoort
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Zaandam, Netherlands
- Zaans Medisch Centrum
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Zoetermeer, Netherlands
- Langeland
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Zutphen, Netherlands
- Gelre Ziekenhuizen
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Zwolle, Netherlands
- Isala Kliniek
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
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
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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
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assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points
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up to 60 months after completion of primary treatment
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Costs-effectiveness
Time Frame: assessed at 60 months after completion of primary treatment
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Cost-effectiveness from the health care perspective using the EQ-5D
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assessed at 60 months after completion of primary treatment
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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
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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
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assessed at 6, 12 and 36 months after completion of primary treatment
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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
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assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
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assessed at baseline, 6, 12, and 36 months after completion of primary treatment
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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
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assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
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Worry including fear of recurrence
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
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assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
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assessed at baseline, 6, 12, and 36 months after completion of primary treatment
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Worry including fear of recurrence
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
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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
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assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
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assessed at baseline, 6, 12, and 36 months after completion of primary treatment
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Illness perceptions
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
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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
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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
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Anxiety and depression
Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment
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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
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Satisfaction with information provision
Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment
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assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
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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
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assessed with structured interviews/questionnaires
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assessed at 36 months after completion of primary treatment
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Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)
Time Frame: assessed at 60 months after completion of primary treatment
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assessed with structured interviews/questionnaires
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assessed at 60 months after completion of primary treatment
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Time till recurrence
Time Frame: assessed at 36 months after completion of primary treatment
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In this study we will descriptively look at time till recurrence
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assessed at 36 months after completion of primary treatment
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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
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assessed at 60 months after completion of primary treatment
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Survival
Time Frame: assessed at 36 months after completion of primary treatment
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descriptively look at survival
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assessed at 36 months after completion of primary treatment
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Survival
Time Frame: assessed at 60 months after completion of primary treatment
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descriptively look at survival
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assessed at 60 months after completion of primary treatment
|
Collaborators and Investigators
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKZ 2014-6677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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