Development of a Shared Decision Tool to Facilitate Uptak... | NCT07382583

ID	Type	Description	Link
NCI-2026-00500	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2026Actual

Primary Completion Date

Feb 1, 2028Estimated

Completion Date

Feb 1, 2030Estimated

First Submitted Date

Jan 22, 2026

First Submission Date that Met QC Criteria

Jan 28, 2026

First Posted Date

Feb 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 25, 2026Actual

Name	Class
Cancer Prevention Research Institute of Texas	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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]).

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Survey using a questionnaire	Other	Patient Preference Utility Assessment and Questionnaires	Phase 1 Phase 2

Measure	Description	Time Frame
Patient Utility Questionnaire		Through study completion; an average of 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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
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:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MD Anderson Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Larissa A Meyer, MD	Contact	713-745-0973		lmeyer@mdanderson.org

Overall Officials

Name	Affiliation	Role
Larissa A Meyer, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Harris Health System (LBJ)	Recruiting	Houston	Texas	77026	United States

Label	URL
MD Anderson Cancer Center	View source

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases