Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, Ovarian Preservation, Ovarian Removal, Endometrial Malignancies, GYN POEM Trial, 20-429, Memorial Sloan Kettering Cancer Center
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.
Interventions
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.
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.
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer | Up to 12 months post-operatively | 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. |
Countries
United States
Contacts
Memorial Sloan Kettering Cancer Center