BREAST Choice Decision Tool R21 - AIM2 (BREASTChoice)
Cultural and Linguistic Adaptation of a Breast Reconstruction Decision Tool - 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meaghan Hazelet
- Phone Number: 919-966-4320
- Email: Meaghan.Hazelet@med.unc.edu
Study Contact Backup
- Name: Victor Catalan Gallegos
- Phone Number: +1 919-966-3215
- Email: victor.gallegos@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- The University of North Carolina
-
Contact:
- Meaghan Hazelet
- Phone Number: 919-966-4320
- Email: Meaghan.Hazelet@med.unc.edu
-
Principal Investigator:
- Clara Lee, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Breast cancer survivors
Latina breast cancer survivors.
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Participants will take a pre-survey to measure demographics, health literacy, numeracy and breast reconstruction decision quality.
Participants will then engage in a self-guided review of the adapted BREASTChoice tool.
Participants will take the post-survey to assess breast reconstruction decision quality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Clara Lee, MPP, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-1340 - AIM2
- R21CA287321 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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