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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Other: Reduced follow-up schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months | Other: Reduced follow-up schedule<br>* 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.<br>|
| No Intervention: control<br>regular follow-up schedule according to the guideline, 10-13 visits during 5 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Costs-effectiveness | Cost-effectiveness from the health care perspective using the EQ-5D | assessed at 60 months after completion of primary treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs-effectiveness | Cost-effectiveness from the health care perspective using the EQ-5D | assessed at 36 months after completion of primary treatment | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time till recurrence | In this study we will descriptively look at time till recurrence | assessed at 36 months after completion of primary treatment | 
| Time till recurrence | In this study we will descriptively look at time till recurrence | assessed at 60 months after completion of primary treatment | 
| Survival | descriptively look at survival | assessed at 36 months after completion of primary treatment | 
| Survival | descriptively look at survival | assessed at 60 months after completion of primary treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow up care, satisfaction with care