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NCT Number: NCT02413606

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced follow-up schedule

Other

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.

Primary outcomes

  1. 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

  2. Costs-effectiveness

    Time frame: assessed at 60 months after completion of primary treatment

    Cost-effectiveness from the health care perspective using the EQ-5D

Secondary outcomes

  1. Costs-effectiveness

    Time frame: assessed at 36 months after completion of primary treatment

    Cost-effectiveness from the health care perspective using the EQ-5D

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Survival

    Time frame: assessed at 36 months after completion of primary treatment

    descriptively look at survival

  19. Survival

    Time frame: assessed at 60 months after completion of primary treatment

    descriptively look at survival

Sponsors and collaborators

Lead sponsor

Comprehensive Cancer Centre The Netherlands

Other

Collaborators

  • Dutch Cancer Society
  • Leiden University Medical Center
  • Maastricht University Medical Center

Registry information

Official study 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

Acronym: ENSURE

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2015
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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