ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
- Conditions
- Endometrial Cancer
- Interventions
- Other: Reduced follow-up schedule
- Registration Number
- NCT02413606
- Lead Sponsor
- Comprehensive Cancer Centre The Netherlands
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 319
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Reduced follow-up schedule reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
- Primary Outcome Measures
Name Time Method Costs-effectiveness assessed at 60 months after completion of primary treatment Cost-effectiveness from the health care perspective using the EQ-5D
Patient satisfaction with follow-up care 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
- Secondary Outcome Measures
Name Time Method Costs-effectiveness assessed at 36 months after completion of primary treatment Cost-effectiveness from the health care perspective using the EQ-5D
Anxiety and depression 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
Health-Related Quality of Live 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
Worry including fear of recurrence 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
Satisfaction with information provision 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
Illness perceptions 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
Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse) assessed at 60 months after completion of primary treatment assessed with structured interviews/questionnaires
Survival assessed at 60 months after completion of primary treatment descriptively look at survival
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 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
Time till recurrence assessed at 60 months after completion of primary treatment In this study we will descriptively look at time till recurrence
Trial Locations
- Locations (45)
Amstelland Ziekenuis
🇳🇱Amstelveen, Netherlands
Gelre Ziekenhuizen
🇳🇱Zutphen, Netherlands
Amphia
🇳🇱Breda, Netherlands
Haga hospital
🇳🇱Den Haag, Netherlands
Röpcke-Zweers Ziekenhuis
🇳🇱Hardenberg, Netherlands
Reinier de Graaf Hospital
🇳🇱Delft, Netherlands
Zuyderland Hospital
🇳🇱Heerlerheide, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
AVL
🇳🇱Amsterdam, Netherlands
MC Haaglanden
🇳🇱Den Haag, Netherlands
AMC
🇳🇱Amsterdam, Netherlands
Jeroen Bosch
🇳🇱Den Bosch, Netherlands
Medical Spectrum Twente
🇳🇱Enschede, Netherlands
Martini Hospital
🇳🇱Groningen, Netherlands
St. Antonius
🇳🇱Nieuwegein, Netherlands
Waterland Ziekenhuis
🇳🇱Purmerend, Netherlands
Vlietland
🇳🇱Schiedam, Netherlands
Elisabeth-TweeSteden
🇳🇱Tilburg, Netherlands
Zuwe Hofpoort
🇳🇱Woerden, Netherlands
Noordwest ziekhuisgroep
🇳🇱Alkmaar, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Groene Hart
🇳🇱Gouda, Netherlands
Elisabeth TweeSteden, TweeSteden
🇳🇱Tilburg, Netherlands
VieCuri
🇳🇱Venlo, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
Bravis
🇳🇱Roosendaal, Netherlands
Tergooi
🇳🇱Blaricum, Netherlands
Deventer Hospital
🇳🇱Deventer, Netherlands
Tjongerschans
🇳🇱Heerenveen, Netherlands
Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Isala kliniek
🇳🇱Zwolle, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Westfries Gasthuis
🇳🇱Hoorn, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Alrijne Ziekenhuis
🇳🇱Leiden, Netherlands
Zuyderland
🇳🇱Sittard, Netherlands
Refaja
🇳🇱Stadskanaal, Netherlands
Bernhoven
🇳🇱Uden, Netherlands
Streekziekenhuis Koningin Beatrix
🇳🇱Winterswijk, Netherlands
Zaans Medisch Centrum
🇳🇱Zaandam, Netherlands
Langeland
🇳🇱Zoetermeer, Netherlands