Clinical trial NCT06817226: BREAST Choice Decision Tool R21
Official title: Cultural and Linguistic Adaptation of a Breast Reconstruction Decision Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: surgery
Breast reconstruction
mastectomy
Spanish-speaking
Latina
The BREASTChoice
Cultural and Linguistic Adaptation Framework
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient participants who are Spanish-speaking breast cancer survivors receive treatment and/or Health Care Providers who treat Spanish-speaking breast cancer patients.

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.


Eligibility 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 speak Spanish at home
* Have a history of breast malignancy (e.g., ductal carcinoma, DCIS) or high risk for breast cancer (e.g., BRCA mutation)
* Had breast surgery within the last 8 years
* Able to understand an IRB-Approved consent information sheet

Inclusion Criteria for Health Care Providers:(must meet all criteria)

* Provides breast cancer care (physicians, nurses, and advanced practice providers in breast surgery, reconstructive surgery, radiation oncology, medical oncology)
* Provides treatment to Spanish-speaking Latina breast cancer survivors
* Able to understand an IRB-Approved consent information sheet

Exclusion Criteria:

-

Primary outcomes:
measure: How should the BREASTChoice decision tool be modified to a Spanish language?
timeFrame: Up to 2 year
measure: What are the key cultural and linguistic adaptations?
timeFrame: Up to 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Clara Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: