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BREAST Choice Decision Tool R21 - AIM2

UNC Lineberger Comprehensive Cancer Center · with National Cancer Institute (NCI) · NCT06817226

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
October 10, 2024
Record last updated
November 25, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pre-survey; BREASTChoice tool.; Post-survey

Conditions: Breast Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

-

Recruiting US locations

  • The University of North Carolina

    Chapel Hill, NC 27599

    Site contact: Meaghan Hazelet · 919-966-4320 · Meaghan.Hazelet@med.unc.edu

Study contacts (from the official record)

  • Victor Catalan Gallegos · +1 919-966-3215 · victor.gallegos@med.unc.edu
  • Meaghan Hazelet · 919-966-4320 · Meaghan.Hazelet@med.unc.edu
BREAST Choice Decision Tool R21 - AIM2 (NCT06817226) | Bored Studies