Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

Study Overview
=================
Brief 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

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Behavioral: Impact of Event Scale-Revised
* Behavioral: Reproductive Concerns Scale
* Behavioral: Decision Regret Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants undergoing surgery for clinical<br>Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer | Behavioral: Impact of Event Scale-Revised<br>* 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.<br>* Other names: IES-R;Behavioral: Reproductive Concerns Scale<br>* 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.<br>* Other names: RCS;Behavioral: Decision Regret Scale<br>* 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.<br>* Other names: DRS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center