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BREAST Choice Decision Tool R21 - AIM2

Cultural and Linguistic Adaptation of a Breast Reconstruction Decision Tool - AIM2

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06817226
Acronym
BREASTChoice
Enrollment
50
Registered
2025-02-10
Start date
2024-10-10
Completion date
2026-08-28
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Surgery, Breast reconstruction, mastectomy, Spanish-speaking, Latina, The BREASTChoice

Brief summary

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.

Interventions

BEHAVIORALPre-survey

Participants will take a pre-survey to measure demographics, health literacy, numeracy and breast reconstruction decision quality.

BEHAVIORALBREASTChoice tool.

Participants will then engage in a self-guided review of the adapted BREASTChoice tool.

BEHAVIORALPost-survey

Participants will take the post-survey to assess breast reconstruction decision quality.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in breast reconstruction knowledgeUp to 2 monthsKnowledge will be calculated before and after the intervention. The number of correct answers divided by the total number of knowledge items. Missing items will be counted as incorrect. A knowledge score will be calculated only if at least 50% of the items are answered. Descriptive statistics will be used.

Countries

United States

Contacts

Primary ContactVictor Catalan Gallegos
victor.gallegos@med.unc.edu+1 919-966-3215
Backup ContactMeaghan Hazelet
Meaghan.Hazelet@med.unc.edu919-966-4320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026