Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 270
- Locations
- 2
- Primary Endpoint
- Patient Utility Questionnaire
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •Unaffected women
- •Must be at least 18 years old
- •Must read and speak English or Spanish
- •Must be premenopausal
- •Must not have a prior history of EC or complex atypical hyperplasia
- •Must provide written, informed consent
- •No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member
- •Affected women
- •Must be at least 18 years old
- •Must read and speak English or Spanish
- •Must have a prior history of EC or complex atypical hyperplasia
- •Must provide written, informed consent
- •No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member
- •Healthcare Providers
- •Physicians or advanced practice providers (physician assistants, nurse practitioners) from Family Medicine, Obstetrics & Gynecology, Internal Medicine, or Endocrinology
- •Must be at least 18 years old
- •Must read and speak English or Spanish
- •Must provide written, informed consent for qualitative interviews
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 2
Develop and pilot test a web-based shared medical decision tool
Intervention: Survey using a questionnaire (Other)
Phase 1
Identify decisional needs, patient values and experiences
Intervention: Survey using a questionnaire (Other)
Outcomes
Primary Outcomes
Patient Utility Questionnaire
Time Frame: Through study completion; an average of 1 year
Secondary Outcomes
No secondary outcomes reported