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

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 - ENSURE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44746

Enrollment

282

Registered

2015-01-15

Start date

2015-09-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer uterine cancer

Interventions

4 follow-up visits, after 3, 12, 24 and 36 months (intervention) vs. regular follow-up according to the guideline, 10-13 visits during 5 years (control)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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,

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Primary outcomes: 1. Patient satisfaction with follow-up care (at 6, 12, 36 and 60 months after completion of primary treatment) 2. Costs-effectiveness from the health care perspective (after 3 and 5 years.)	—

Secondary

Measure	Time frame
Secondary outcomes: • 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 • HRQoL, worry including fear of recurrence, anxiety and depression, and satisfaction with information provision • Health care providers* satisfaction with follow-up schedule (gynaecologist, (specialised) nurse) • Time till recurrence and survival.	—

Measure

Time frame

Secondary outcomes: • 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 • HRQoL, worry including fear of recurrence, anxiety and depression, and satisfaction with information provision • Health care providers* satisfaction with follow-up schedule (gynaecologist, (specialised) nurse) • Time till recurrence and survival.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)