BREAST Choice Decision Tool R21 - AIM2
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Study ID
- NCT06817226
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Pre-survey — BEHAVIORALParticipants will take a pre-survey to measure demographics, health literacy, numeracy and breast reconstruction decision quality.
- BREASTChoice tool. — BEHAVIORALParticipants will then engage in a self-guided review of the adapted BREASTChoice tool.
- Post-survey — BEHAVIORALParticipants will take the post-survey to assess breast reconstruction decision quality.
Study Details
Breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy. However, Spanish-speaking Latina women are significantly less likely to undergo reconstruction (13.5% vs. 41% for non-Latina White or highly acculturated Latina), meet with a reconstructive surgeon (18.1% vs. 72.6% for non-Latina White), or receive adequate information. Spanish-speaking Latina breast cancer survivors who do not have reconstruction experience the highest rates of decisional dissatisfaction and regret, compared to any other group of breast cancer survivors. Persons diagnosed with cancer who primarily speak Spanish and identify as Latin American (hereafter we use the term "Spanish-speaking Latinx/a cancer survivor") are less likely to receive guideline-concordant treatment and more likely to have poor cancer outcomes. One way to improve guideline-concordant treatment is through shared decision-making and decision support. When a decision is preference-sensitive (the right choice depends on the person's preferences), such as decisions about breast reconstruction after mastectomy, decision aids are effective. Unfortunately, most decision aids in the United States are written in English and developed or tested with few Latinx people. The BREASTChoice decision aid, proven effective in two randomized controlled trials, addresses knowledge gaps in breast cancer survivors. This study focuses on developing a Spanish-language version of BREASTChoice, which was previously unavailable. For that reason, the Cultural and Linguistic Adaptation Framework (CLAF) incorporates qualitative and experiential data to adapt BREASTChoice. The adaptation process takes place in five steps: appraise, review, assess, solicit, and integrate.
Key Dates
- Start date
- Oct 10, 2024
- Status verified
- Nov 2025
- Primary completion
- Aug 28, 2026
- Completion
- Aug 28, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Other: Breast cancer survivorsLatina breast cancer survivors.
Primary Outcome Measure
Change in breast reconstruction knowledge [ Time Frame: Up to 2 months ]
Central Contacts
- Victor Catalan Gallegos+1 919-966-3215
- Meaghan Hazelet919-966-4320
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of North Carolina | Chapel Hill | North Carolina | 27599 | Clara Lee, MD (PRINCIPAL_INVESTIGATOR) |
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