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Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04569773
Enrollment
43
Registered
2020-09-30
Start date
2020-09-23
Completion date
2027-09-23
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center

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.

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.

BEHAVIORALReproductive Concerns Scale

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.

BEHAVIORALDecision Regret Scale

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancerUp to 12 months post-operativelyExamine 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Mueller, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026