ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?

Endometrial Cancer Clinical Trial

— ENSURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413606
• Other study ID #: IKZ 2014-6677
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2022

Study information

• Verified date: December 2023
• Source: Comprehensive Cancer Centre The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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;

2. Written informed consent;

3. Sufficient oral and written command of the Dutch language.

Exclusion Criteria:

1. Any other stage and type of endometrial carcinoma

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
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	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

Sponsors (4)

Lead Sponsor	Collaborator
Comprehensive Cancer Centre The Netherlands	Dutch Cancer Society, Leiden University Medical Center, Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Costs-effectiveness	Cost-effectiveness from the health care perspective using the EQ-5D	assessed at 60 months after completion of primary treatment
Secondary	Costs-effectiveness	Cost-effectiveness from the health care perspective using the EQ-5D	assessed at 36 months after completion of primary treatment
Secondary	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	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 and 36 months after completion of primary treatment
Secondary	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	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
Secondary	Health-Related Quality of Live	assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; 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
Secondary	Health-Related Quality of Live	assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; 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
Secondary	Worry including fear of recurrence	assessed with questionnaire: IOCv2; 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
Secondary	Worry including fear of recurrence	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
Secondary	Illness perceptions	assessed with questionnaire: BIPQ; 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
Secondary	Illness perceptions	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
Secondary	Anxiety and depression	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
Secondary	Anxiety and depression	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
Secondary	Satisfaction with information provision	assessed with questionnaire: EORTC-INFO25; 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
Secondary	Satisfaction with information provision	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
Secondary	Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)	assessed with structured interviews/questionnaires	assessed at 36 months after completion of primary treatment
Secondary	Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse)	assessed with structured interviews/questionnaires	assessed at 60 months after completion of primary treatment
Secondary	Time till recurrence	In this study we will descriptively look at time till recurrence	assessed at 36 months after completion of primary treatment
Secondary	Time till recurrence	In this study we will descriptively look at time till recurrence	assessed at 60 months after completion of primary treatment
Secondary	Survival	descriptively look at survival	assessed at 36 months after completion of primary treatment
Secondary	Survival	descriptively look at survival	assessed at 60 months after completion of primary treatment