NCT04569773

Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Impact of Event Scale-Revised	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.
BEHAVIORAL	Reproductive 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.
BEHAVIORAL	Decision 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.

Timeline

• Start date: 2020-09-23
• Primary completion: 2026-09-23
• Completion: 2026-09-23
• First posted: 2020-09-30
• Last updated: 2025-08-22

Locations

8 sites across 1 country: United States