Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-23

Study Completion Date

2026-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants undergoing surgery for clinical

Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer

Impact of Event Scale-Revised

Intervention Type 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.

Reproductive Concerns Scale

Intervention Type 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.

Decision Regret Scale

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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IES-R RCS DRS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No