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Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569773
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Endometrial Cancer Behavioral: Impact of Event Scale-Revised Behavioral: Reproductive Concerns Scale Behavioral: Decision Regret Scale

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preservation of Ovaries in Endometrial Malignancies: GYN POEM Trial
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : September 23, 2024
Estimated Study Completion Date : September 23, 2024

Group/Cohort Intervention/treatment
Participants undergoing surgery for clinical
Participants will be undergoing surgery for clinical stage I endometrioid endometrial cancer
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.
Other Name: IES-R

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.
Other Name: RCS

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.

Other Name: DRS




Primary Outcome Measures :
  1. Examine the decision-making process of patients who choose to undergo or not undergo ovarian-sparing surgical treatment of endometrial cancer [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the Gynecology Service, Department of Surgery, at MSK. All women undergoing surgery for endometrial cancer without clear preoperative suspicion for advanced-stage disease will be screened for participation in this study. No selectivity will be exercised by the investigators to minimize bias. The specific type of surgery for each patient, as well as its timing, will be determined by the treating gynecological surgeon.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569773


Contacts
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Contact: Jennifer Mueller, MD 212-639-8229 muellerj@mskcc.org
Contact: Nadeem Abu-Rustum, MD 212-639-7051 abu-rusn@mskcc.org

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jennifer Mueller, MD    212-639-8229      
Memorial Sloan Kettering Monmouth (All protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Jennifer Mueller, MD    212-639-8229      
Memorial Sloan Kettering Bergen (All protocol activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Jennifer Mueller, MD    212-639-8229      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk (All protocol activities) Recruiting
Commack, New York, United States, 11725
Contact: Jennifer Mueller, MD    212-639-8229      
Memorial Sloan Kettering Westchester (All protocol activities) Recruiting
Harrison, New York, United States, 10604
Contact: Jennifer Mueller, MD    212-639-8229      
Memorial Sloan Kettering Cancer Center (All Study Activities) Recruiting
New York, New York, United States, 10065
Contact: Jennifer Mueller, MD    212-639-8229      
Memorial Sloan Kettering Nassau (All protocol activities) Recruiting
Rockville Centre, New York, United States, 11553
Contact: Jennifer Mueller, MD    212-639-8229      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jennifer Mueller, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04569773    
Other Study ID Numbers: 20-429
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Endometrial Cancer
Ovarian Preservation
Ovarian Removal
Endometrial Malignancies
GYN POEM Trial
20-429
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases