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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Dutch Cancer Society
Maastricht University Medical Center
Leiden University Medical Center
Information provided by (Responsible Party):
Nicole Ezendam, Comprehensive Cancer Centre The Netherlands

Study Description
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Brief Summary:

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
Endometrial Cancer Other: Reduced follow-up schedule Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, < 60 years, grade 1 or 2 without LVSI;

  2. Written informed consent;
  3. Sufficient 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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Sponsors and Collaborators
Comprehensive Cancer Centre The Netherlands
Dutch Cancer Society
Maastricht University Medical Center
Leiden University Medical Center
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Nicole Ezendam, Comprehensive Cancer Centre The Netherlands:
follow up care
satisfaction with care
Additional relevant MeSH terms:
Layout table for MeSH terms
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