Shared decision tool to help choose the levonorgestrel IUD for preventing endometrial cancer
Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
This project will try a web-based decision tool in English and Spanish to help women at risk of endometrial cancer and their healthcare providers consider using a levonorgestrel-releasing IUD for prevention.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT07382583 on ClinicalTrials.gov |
What this trial studies
The study uses a two-phase, mixed-methods approach to build and test a personalized shared decision-making tool focused on the levonorgestrel-releasing intrauterine system (LNG-IUS) for primary prevention of endometrial cancer. Phase 1 will use interviews and surveys with unaffected and affected women plus clinicians to identify decisional needs, values, and preferences. Phase 2 will develop an English and Spanish web-based tool that includes a personalized endometrial cancer risk calculator and will be field-tested with the target users. The tool is designed to prepare patients for clinician conversations and will not replace clinical consultations.
Who should consider this trial
Good fit: Adults aged 18 or older who read English or Spanish—either premenopausal women without prior endometrial cancer but at risk, women with a history of endometrial cancer or complex atypical hyperplasia, and clinicians who care for them—are the intended participants.
Not a fit: People who are postmenopausal, who cannot consider an IUD for medical reasons, or who do not read English or Spanish are unlikely to benefit from this tool.
Why it matters
Potential benefit: If successful, the tool could help women understand their personalized endometrial cancer risk and make more informed choices about using an LNG-IUS for prevention.
How similar studies have performed: Shared decision tools have improved informed choices in contraception and cancer screening, but applying an LNG-IUS specifically for primary endometrial cancer prevention is relatively less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Unaffected women 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Must be premenopausal 4. Must not have a prior history of EC or complex atypical hyperplasia 5. Must provide written, informed consent 6. No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member 2. Affected women 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Must have a prior history of EC or complex atypical hyperplasia 4. Must provide written, informed consent 5. No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member 3. Healthcare Providers 1. Physicians or advanced practice providers (physician assistants, nurse practitioners) from Family Medicine, Obstetrics \& Gynecology, Internal Medicine, or Endocrinology 2. Must be at least 18 years old 3. Must read and speak English or Spanish 4. Must provide written, informed consent for qualitative interviews Exclusion Criteria: * N/A
Where this trial is running
Houston, Texas and 1 other locations
- The Harris Health System (LBJ) — Houston, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Larissa A Meyer, MD — M.D. Anderson Cancer Center
- Study coordinator: Larissa A Meyer, MD
- Email: lmeyer@mdanderson.org
- Phone: 713-745-0973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.