Decision-making support for Spanish-speaking Latina breast cancer survivors
Cultural and Linguistic Adaptation of a Breast Reconstruction Decision Tool - AIM2
This study is trying to help Spanish-speaking Latina breast cancer survivors make better decisions about breast reconstruction after surgery by gathering their input to improve a decision-making tool.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06817226 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on improving decision-making for Spanish-speaking Latina women diagnosed with breast cancer, particularly regarding breast reconstruction after mastectomy. It aims to assess the decision-making context and solicit input from the target population to refine a decision aid that addresses their specific needs. By enhancing shared decision-making, the study seeks to increase the likelihood of these women receiving guideline-concordant treatment and improving their overall satisfaction with care.
Who should consider this trial
Good fit: Ideal candidates for this study are Spanish-speaking Latina women aged 18 and older who have a history of breast cancer and have undergone breast surgery within the last 8 years.
Not a fit: Patients who do not identify as Latina or who are not Spanish-speaking may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower Spanish-speaking Latina breast cancer survivors to make informed decisions about their treatment options, potentially improving their quality of life.
How similar studies have performed: Other studies have shown success in using decision aids to improve treatment decision-making in diverse populations, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Survivors: (must meet all criteria) * Female sex * Adult at least 18 years of age * Latina, Latino, or Latinx ethnicity - defined as born in or descending from South America, Mexico, Central America, other Spanish-speaking Caribbean islands * Prefer to receive health information in Spanish * Have a history of breast malignancy (e.g., ductal carcinoma, DCIS) or high risk for breast cancer (e.g., BRCA mutation) * Had breast surgery (Mastectomy/Lumpectomy/Mastectomy but no reconstruction) within the last 8 years * Able to understand an IRB-Approved consent information sheet Exclusion Criteria: \-
Where this trial is running
Chapel Hill, North Carolina
- The University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Clara Lee, MPP, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Victor Catalan Gallegos
- Email: victor.gallegos@med.unc.edu
- Phone: +1 919-966-3215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.