Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569773
• Other study ID #: 20-429
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: September 23, 2024

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jennifer Mueller, MD
• Phone: 212-639-8229
• Email: muellerj[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 23, 2024
• Est. primary completion date: September 23, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• 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.
• 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

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	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	Hartford Healthcare (Data Collection)	Hartford	Connecticut
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 (All Study Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer	Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer to identify influencing factors-in particular, cancer-related psychological distress and reproductive concerns-and any potential decisional regrets following surgical intervention.	Up to 12 months post-operatively

External Links

•   Memorial Sloan Kettering Cancer Center