Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
1 other identifier
observational
43
1 country
8
Brief Summary
The purpose of this study is to learn more about the factors that influence decision-making before surgery (distress about cancer and/or reproductive concerns) and the possibility of regret after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2020
CompletedFirst Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 23, 2026
August 22, 2025
August 1, 2025
6 years
September 24, 2020
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer to identify influencing factors-in particular, cancer-related psychological distress and reproductive concerns-and any potential decisional regrets following surgical intervention.
Up to 12 months post-operatively
Study Arms (1)
Participants undergoing surgery for clinical
Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer
Interventions
The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.
The RCS is a 14-item, 5-point Likert-type self-report measure that assesses concern among cancer survivors whose reproductive ability may have been impaired or lost due to disease and/or treatment. Answers are rated on a 5-point scale (0 to 4), and a single total score is produced by summing responses to all 14 items (range, 0-56 points). A higher score represents more reproductive concerns, and a lower score represents fewer reproductive concerns. In the RCS validation study, internal consistency reliability was 0.91 among long-term female cancer survivors and 0.81 among control women.
The DRS is a 5-item, 5-point Likert-type self-report measure that assesses distress or remorse after a health-care decision.5 Items are rated on a scale from 1 ("strongly agree") to 5 ("strongly disagree"). Two of the statements (items 2 and 4) are phrased in the negative direction. A single, total score is produced by first reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. This mean is then rescaled to range from 0 to 100 by subtracting 1, then multiplying by 25. A score of 0 indicates no regret, whereas a score of 100 indicates high regret. Internal consistency reliability coefficients for the DRS range from 0.81 to 0.92.
Eligibility Criteria
Patients will be recruited from the Gynecology Service, Department of Surgery, at MSK. All women undergoing surgery for endometrial cancer without clear preoperative suspicion for advanced-stage disease will be screened for participation in this study. No selectivity will be exercised by the investigators to minimize bias. The specific type of surgery for each patient, as well as its timing, will be determined by the treating gynecological surgeon.
You may qualify if:
- Women aged ≥ 18 and ≤ 50 years
- Premenopausal
- Endometrioid histological diagnosis
- Scheduled for surgical intervention at MSKCC
- FIGO grade 1-2, clinical stage I
- Disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (MRI preferred, ultrasound optional)
- Normal ovaries on preoperative imaging
- Able to provide informed consent
- English-speaking
You may not qualify if:
- Known Lynch syndrome
- Prior bilateral oophorectomy
- Personal history of hormone receptor-positive breast carcinoma
- Increased risk of ovarian cancer identified on the basis of family or personal history
- Women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to AMH
- Women who recently underwent ovarian stimulation within the past 3 months may not opt-in to AMH
- Women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to AMH
- Women who completed chemotherapy within \<12 months may not opt-in to AMH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hartford Healthcare (Data Collection)
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Study Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Mueller, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2020
First Posted
September 30, 2020
Study Start
September 23, 2020
Primary Completion (Estimated)
September 23, 2026
Study Completion (Estimated)
September 23, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.