Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-10-10
2026-08-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Breast cancer survivors
Latina breast cancer survivors.
Pre-survey
Participants will take a pre-survey to measure demographics, health literacy, numeracy and breast reconstruction decision quality.
BREASTChoice tool.
Participants will then engage in a self-guided review of the adapted BREASTChoice tool.
Post-survey
Participants will take the post-survey to assess breast reconstruction decision quality.
Interventions
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Pre-survey
Participants will take a pre-survey to measure demographics, health literacy, numeracy and breast reconstruction decision quality.
BREASTChoice tool.
Participants will then engage in a self-guided review of the adapted BREASTChoice tool.
Post-survey
Participants will take the post-survey to assess breast reconstruction decision quality.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Clara Lee, MPP, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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The University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Clinical trials at UNC Lineberger
Other Identifiers
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24-1340 - AIM2
Identifier Type: -
Identifier Source: org_study_id
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