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ACTIVE NOT RECRUITING
NCT04569773

Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

43

Start Date

2020-09-23

Completion Date

2026-09-23

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

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.

Locations (8)

Hartford Healthcare (Data Collection)

Hartford, Connecticut, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Study Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States