CClinicalTrials.gg
RecruitingNCT07382583Updated Aug 12, 2026

Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer

An observational study in Levonorgestrel, Intrauterine Systems and Prevention, sponsored by M.D. Anderson Cancer Center. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
270
Ages
18 Years and older
Sex
Female
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Study summary

To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system [LNG-IUS]).

Read the detailed description

Primary Objectives

The overall goal of this study is to create a personalized decision support educational tool for the use of LNG-IUS as a primary prevention strategy for women at risk of EC. The decision support tool will not replace the consultation with a clinician. Rather, it will help prepare the participant to better understand their options and prepare them for conversations with clinicians when making a decision about use of LNG-IUS. The primary objectives will be accomplished in two phases:

Phase 1 Primary Objective:

1. To identify decisional needs, participant values, and experiences for preferences regarding LNG-IUS through a mixed-methods approach

Phase 2 Primary Objective:

1. To develop and field-test a novel web-based SDM tool in English and Spanish incorporating a personalized EC risk calculator and focused on LNG-IUS as a primary prevention strategy

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Conditions studied

  • Levonorgestrel
  • Intrauterine Systems
  • Prevention
  • Endometrial Cancer
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In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's planned enrollment of 270 is above the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

MD Anderson Cancer Center

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

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

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
270 participants (estimated)
Patient registry
No

Groups and cohorts

  • Phase 1

    Identify decisional needs, patient values and experiences

    Other: Survey using a questionnaire

  • Phase 2

    Develop and pilot test a web-based shared medical decision tool

    Other: Survey using a questionnaire

Interventions

  • OtherSurvey using a questionnaire

    Patient Preference Utility Assessment and Questionnaires

06

What researchers measure

Primary outcomes

  1. Patient Utility Questionnaire

    Time frame: Through study completion; an average of 1 year

07

Study locations

2 of 2 sites recruiting
  • The Harris Health System (LBJ)
    Houston, Texas 77026, United States
    • Larissa Meyer, MD · Contact · lmeyer@mdanderson.org · 281-682-8359
    • Larissa Meyer, MD · Principal investigator
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Larissa A Meyer, MD · Contact · lmeyer@mdanderson.org · 713-745-0973
    • Larissa A Meyer, MD · Principal investigator
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07382583
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
Cancer Prevention Research Institute of Texas
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Feb 12, 2026
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2030 (estimated)
Last update
Aug 12, 2026

Study contacts

Larissa A Meyer, MD
Contact
lmeyer@mdanderson.org
713-745-0973
Larissa A Meyer, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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