Clinical trial · Observational
Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
NCT07382583CI-TRIAL-00121757recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \[LNG-IUS\]).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Intrauterine Systems | — | UNRESOLVED | — |
| Levonorgestrel | — | UNRESOLVED | — |
| Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey using a questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Phase 1
- description
- Identify decisional needs, patient values and experiences
- interventionNames
- Other: Survey using a questionnaire
- label
- Phase 2
- description
- Develop and pilot test a web-based shared medical decision tool
- interventionNames
- Other: Survey using a questionnaire
Primary outcomes (1)
- measure
- Patient Utility Questionnaire
- timeFrame
- Through study completion; an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: 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
References
Publications (0)
Data not yet available
No reference posted for this study.