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

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

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.

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.

assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points

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

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 with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points

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 with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points

assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points

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

After ending the study and analysis of the data, data becomes available for use by other researchers via PROFILES registry, according to the their terms

Ezendam NPM, de Rooij BH, Kruitwagen RFPM, Creutzberg CL, van Loon I, Boll D, Vos MC, van de Poll-Franse LV. ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial. Trials. 2018 Apr 16;19(1):227. doi: 10.1186/s13063-018-2611-x.