Thinking of joining a study?

Register your interest

NCT06817226 | RECRUITING | Breast Cancer


BREAST Choice Decision Tool R21
Sponsor:

UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease

Breast Cancer

Intervention/treatment

Assess decision making context.

Solicit input from the target population

Integration and refinemen of the decision aid

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Cultural and Linguistic Adaptation of a Breast Reconstruction Decision Tool
Actual Study Start Date : 2024-10-10
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
    • -

    BREAST Choice Decision Tool R21

    Location Details

    NCT06817226


    Please Choose a site



    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    RECRUITING

    United States, North Carolina

    The University of North Carolina

    Chapel Hill, North Carolina, United States, 27599

    Loading...