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NCT Number: NCT06817226

BREAST Choice Decision Tool R21 - AIM2

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Clara Lee, MD

PRINCIPAL_INVESTIGATOR

Meaghan Hazelet

CONTACT

[email protected]

919-966-4320

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Pre-survey

Behavioral

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

BREASTChoice tool.

Behavioral

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

Post-survey

Behavioral

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

Primary outcomes

  1. Change in breast reconstruction knowledge

    Time frame: Up to 2 months

    Knowledge 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meaghan Hazelet

CONTACT

[email protected]

919-966-4320

Victor Catalan Gallegos

CONTACT

[email protected]

+1 919-966-3215

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: BREASTChoice

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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