Shared decision tool to help choose the levonorgestrel IUD for preventing endometrial cancer
Official title: Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
Run by M.D. Anderson Cancer Center · NCT07382583 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 270 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | February 1, 2028 |
| Study ends | February 1, 2030 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07382583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
This study will include participants from three categories: Unaffected women, Affected women, and Healthcare Providers. The eligibility criteria for each group are listed below: 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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.