Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Active, not recruitingOBSERVATIONAL
Enrollment

43

Participants

Timeline

Start Date

September 23, 2020

Primary Completion Date

September 23, 2026

Study Completion Date

September 23, 2026

Conditions
Endometrial Cancer
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."

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center (All Study Activities), New York

10604

Memorial Sloan Kettering Westchester (All protocol activities), Harrison

11553

Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre

11725

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

06102

Hartford Healthcare (Data Collection), Hartford

07920

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (All protocol activities), Middletown

07645

Memorial Sloan Kettering Bergen (All protocol activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT04569773 - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer | Biotech Hunter | Biotech Hunter