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

• ClinicalTrials.gov Identifier: NCT02413606
• Recruitment Status: Unknown
• First Posted: April 10, 2015
• Last Update Posted: August 7, 2019
• Sponsor: Comprehensive Cancer Centre The Netherlands
• Collaborators: Dutch Cancer Society; Maastricht University Medical Center; Leiden University Medical Center
• Information provided by (Responsible Party): Nicole Ezendam, Comprehensive Cancer Centre The Netherlands

Tracking Information

• First Submitted Date: March 24, 2015
• First Posted Date: April 10, 2015
• Last Update Posted Date: August 7, 2019
• Actual Study Start Date: September 2015
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2015)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 9, 2015)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Health Services Research
• Condition: Endometrial Cancer

Intervention

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.

Study Arms

• Experimental: Intervention
  reduced follow-up schedule: 4 follow-up visits, after 3, 12, 24 and 36 months
  Intervention: Other: Reduced follow-up schedule
• No Intervention: control
  regular follow-up schedule according to the guideline, 10-13 visits during 5 years

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 5, 2019): 299
• Original Estimated Enrollment (submitted: April 9, 2015): 282
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02413606
• Other Study ID Numbers: IKZ 2014-6677
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

• Current Responsible Party: Nicole Ezendam, Comprehensive Cancer Centre The Netherlands
• Original Responsible Party: Same as current
• Current Study Sponsor: Comprehensive Cancer Centre The Netherlands
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• 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

• PRS Account: Comprehensive Cancer Centre The Netherlands
• Verification Date: August 2019