ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? (ENSURE)
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ClinicalTrials.gov Identifier: NCT02413606 |
Recruitment Status : Unknown
Verified August 2019 by Nicole Ezendam, Comprehensive Cancer Centre The Netherlands.
Recruitment status was: Recruiting
First Posted : April 10, 2015
Last Update Posted : August 7, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Endometrial Cancer | Other: Reduced follow-up schedule | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 299 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Health Services Research |
Official 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 |
Actual Study Start Date : | September 2015 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
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Experimental: Intervention
reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
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Other: Reduced follow-up schedule
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. |
No Intervention: control
regular follow-up schedule according to the guideline, 10-13 visits during 5 years
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- Patient satisfaction with follow-up care [ Time Frame: up to 60 months after completion of primary treatment ]assessed with the PSQIII questionnaire; analysed with a repeated mixed model as one overall outcome over all time points
- Costs-effectiveness [ Time Frame: assessed at 60 months after completion of primary treatment ]Cost-effectiveness from the health care perspective using the EQ-5D
- Costs-effectiveness [ Time Frame: assessed at 36 months after completion of primary treatment ]Cost-effectiveness from the health care perspective using the EQ-5D
- 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 [ Time Frame: assessed at 6, 12 and 36 months after completion of primary treatment ]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 [ Time Frame: assessed at 6, 12, 36, and 60 months after completion of primary treatment ]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-Related Quality of Live [ Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment ]assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
- Health-Related Quality of Live [ Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment ]assessed with questionnaires: EORTC QLQ-C30 and EORTC QLQ-EN24; analysed with a repeated mixed model as one overall outcome over all time points
- Worry including fear of recurrence [ Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment ]assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
- Worry including fear of recurrence [ Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment ]assessed with questionnaire: IOCv2; analysed with a repeated mixed model as one overall outcome over all time points
- Illness perceptions [ Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment ]assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
- Illness perceptions [ Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment ]assessed with questionnaire: BIPQ; analysed with a repeated mixed model as one overall outcome over all time points
- Anxiety and depression [ Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment ]assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
- Anxiety and depression [ Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment ]assessed with questionnaire: HADS; analysed with a repeated mixed model as one overall outcome over all time points
- Satisfaction with information provision [ Time Frame: assessed at baseline, 6, 12, and 36 months after completion of primary treatment ]assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
- Satisfaction with information provision [ Time Frame: assessed at baseline, 6, 12, 36, and 60 months after completion of primary treatment ]assessed with questionnaire: EORTC-INFO25; analysed with a repeated mixed model as one overall outcome over all time points
- Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse) [ Time Frame: assessed at 36 months after completion of primary treatment ]assessed with structured interviews/questionnaires
- Health care providers' satisfaction with follow-up schedule (gynaecologist, (specialised) nurse) [ Time Frame: assessed at 60 months after completion of primary treatment ]assessed with structured interviews/questionnaires
- Time till recurrence [ Time Frame: assessed at 36 months after completion of primary treatment ]In this study we will descriptively look at time till recurrence
- Time till recurrence [ Time Frame: assessed at 60 months after completion of primary treatment ]In this study we will descriptively look at time till recurrence
- Survival [ Time Frame: assessed at 36 months after completion of primary treatment ]descriptively look at survival
- Survival [ Time Frame: assessed at 60 months after completion of primary treatment ]descriptively look at survival

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413606
Contact: Nicole Ezendam, PhD | +31 88 2346096 | n.ezendam@iknl.nl | |
Contact: Lonneke van de Poll-Franse, PhD | +31 88 2346273 | l.vandepoll@iknl.nl |

Principal Investigator: | Lonneke van de Poll-Franse, PhD | Comprehensive Cancer Centre The Netherlands | |
Principal Investigator: | Roy Kruitwagen, PhD | Maastricht University Medical Centre | |
Principal Investigator: | Carien Creutzberg, PhD | Leiden University Medical Centre | |
Principal Investigator: | Nicole Ezendam, PhD | Comprehensive Cancer Centre The Netherlands |
Responsible Party: | Nicole Ezendam, Dr., Comprehensive Cancer Centre The Netherlands |
ClinicalTrials.gov Identifier: | NCT02413606 |
Other Study ID Numbers: |
IKZ 2014-6677 |
First Posted: | April 10, 2015 Key Record Dates |
Last Update Posted: | August 7, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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 |
follow up care satisfaction with care |
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |