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

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.

Conditions

• Endometrial Cancer

Interventions

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.

Sponsors & Collaborators

• Dutch Cancer Society

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Comprehensive Cancer Centre The Netherlands

  lead OTHER

Principal Investigators

• Lonneke van de Poll-Franse, PhD · Comprehensive Cancer Centre The Netherlands

• Roy Kruitwagen, PhD · Maastricht University Medical Centre

• Carien Creutzberg, PhD · Leiden University Medical Centre

• Nicole Ezendam, PhD · Comprehensive Cancer Centre The Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• Netherlands

Study Locations