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

Recruiting

Conditions: endometrial cancer
uterine cancer
10046828

Registration Number: NL-OMON44746

Lead Sponsor: niversiteit van Tilburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 282

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 LVS
2. Written informed consent
3. Sufficiënt 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes:<br /><br>1. Patient satisfaction with follow-up care (at 6, 12, 36 and 60 months after<br /><br>completion of primary treatment)<br /><br>2. Costs-effectiveness from the health care perspective (after 3 and 5 years.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes:<br /><br>• Health care use -gynaecologist, (specialist) nurse, primary care physician<br /><br>and other health or care services-; adherence to the indicated follow-up<br /><br>protocols; reasons for non-adherence<br /><br>• HRQoL, worry including fear of recurrence, anxiety and depression, and<br /><br>satisfaction with information provision<br /><br>• Health care providers* satisfaction with follow-up schedule (gynaecologist,<br /><br>(specialised) nurse)<br /><br>• Time till recurrence and survival.</p><br>