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OpenTrials
Active, not recruiting

NCT Number: NCT04569773

Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hartford Healthcare (Data Collection), Hartford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Impact of Event Scale-Revised

Behavioral

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.

Other names: IES-R

Reproductive Concerns Scale

Behavioral

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.

Other names: RCS

Decision Regret Scale

Behavioral

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.

Other names: DRS

Primary outcomes

  1. Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer

    Time frame: Up to 12 months post-operatively

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2020
Registry last updated
Aug 20, 2026

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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