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

Comprehensive Cancer Centre The Netherlands

Status: Completed

Conditions: Endometrial Cancer

Treatments: Other: Reduced follow-up schedule

Study type: Interventional

Funder types: Other

Identifiers

NCT02413606

IKZ 2014-6677

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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319 participants in 2 patient groups

Intervention

Experimental group

Description:

reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months

Treatment:

Other: Reduced follow-up schedule

control

No Intervention group

Description:

regular follow-up schedule according to the guideline, 10-13 visits during 5 years