Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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.


Options:
A: Arm Label: Survivorship Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Survivorship Intervention | Arm Label: Facing Forward; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Facing Forward | Intervention Type: BEHAVIORAL; Name: Survivorship Intervention; Assigned to Arm(s): Survivorship Intervention | Intervention Type: BEHAVIORAL; Name: Facing Forward; Assigned to Arm(s): Facing Forward
B: Arm Label: minimal surveillance; Type: OTHER; Interventions: Other: surveillance program after completion of primary treatment | Arm Label: intensive surveillance; Type: OTHER; Interventions: Other: surveillance program after completion of primary treatment | Intervention Type: OTHER; Name: surveillance program after completion of primary treatment; Assigned to Arm(s): intensive surveillance, minimal surveillance
C: Arm Label: intervention group; Type: ACTIVE_COMPARATOR; Interventions: Device: distress thermometer | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: distress thermometer; Assigned to Arm(s): intervention group
D: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Reduced follow-up schedule | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Reduced follow-up schedule; Assigned to Arm(s): Intervention

Answer: D