Levonorgestrel, Intrauterine Systems, Prevention, Endometrial Cancer
Conditions
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
Interventions
Patient Preference Utility Assessment and Questionnaires
Sponsors
M.D. Anderson Cancer Center
Cancer Prevention Research Institute of Texas
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Utility Questionnaire | Through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTLarissa A Meyer, MD
PRINCIPAL_INVESTIGATORLarissa A Meyer, MD
M.D. Anderson Cancer Center
Outcome results
None listed