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Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

NCT04569773 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-08-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Jennifer Mueller, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2026-09-23
Completion
2026-09-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04569773 on ClinicalTrials.gov