Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06817226

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pre-survey

BREASTChoice tool.

Post-survey

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06817226

Start date

Oct 10, 2024

Status verified date

Nov, 2025

Completion date

Aug 28, 2026

Anticipated

Primary completion date

Aug 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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:

\-

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Breast cancer survivors

Latina breast cancer survivors.

Interventions

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.

Primary outcome measure

  • Change in breast reconstruction knowledge [ Time Frame: Up to 2 months ]

Central Contacts and Locations

Locations

The University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Clara Lee, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-11-25.