Actively Recruiting

Age: 18Years +
FEMALE
ID07382583

Development of a Shared Decision Tool to Help Women Use the Levonorgestrel-releasing Intrauterine System for Preventing Endometrial Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-02-25

270

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

C

Cancer Prevention Research Institute of Texas

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing an educational tool to help women at risk of endometrial cancer (EC) and healthcare professionals make informed decisions about prevention options, including the use of a levonorgestrel-releasing intrauterine system (LNG-IUS). The study aims to create a personalized decision support tool to prepare patients for discussions with clinicians about LNG-IUS as a primary prevention strategy. This observational study is led by M.D. Anderson Cancer Center and focuses on understanding patient needs and values. The study is conducted in two phases. Phase 1 involves identifying decisional needs, patient values, and experiences regarding LNG-IUS through surveys and questionnaires. Phase 2 focuses on developing and pilot testing a web-based shared decision-making (SDM) tool available in English and Spanish, which includes a personalized EC risk calculator. This tool is intended to support women in making prevention decisions but does not replace clinical consultations. Participants will complete surveys and questionnaires assessing their preferences and values related to LNG-IUS use. The researchers will measure outcomes using a Patient Utility Questionnaire over approximately one year. The study includes both women affected and unaffected by EC, as well as healthcare providers. The total participation time varies by participant, and the study monitors how well the tool supports decision-making about EC prevention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women at least 18 years old
  • Able to read and speak English or Spanish
  • Premenopausal women without a history of endometrial cancer or complex atypical hyperplasia
  • Women with a prior history of endometrial cancer or complex atypical hyperplasia
  • Able to provide written, informed consent
  • No physical, psychological, or cognitive impairments preventing participation in interviews as assessed by the study team
  • Physicians or advanced practice providers in Family Medicine, Obstetrics & Gynecology, Internal Medicine, or Endocrinology
  • Healthcare providers at least 18 years old
  • Healthcare providers able to read and speak English or Spanish
  • Healthcare providers able to provide written, informed consent for qualitative interviews
Not Eligible

You will not qualify if you...

  • No specific exclusion criteria provided

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Observational Assessment

Duration - Up to 1 year

Participants complete surveys and questionnaires to assess decisional needs, values, and experiences related to the levonorgestrel-releasing intrauterine system (LNG-IUS) for endometrial cancer prevention.

Surveys completed periodically throughout the study

Trial Site Locations

Total: 2 locations

1

The Harris Health System (LBJ)

Houston, Texas, United States, 77026

Actively Recruiting

2

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

L

Larissa A Meyer, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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