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NCT06817226 · ClinicalTrials.gov registry record · NA

BREAST Choice Decision Tool R21 - AIM2

A NA study of Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT06817226: Recruiting NA study of Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT06817226 is a NA study of Breast Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06817226, a NA study of Breast Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BEHAVIORAL Pre-survey
  • BEHAVIORAL BREASTChoice tool.
  • BEHAVIORAL Post-survey

Study Locations (1)

North Carolina

  • The University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-10-10
Est. Completion 2026-08-28
Phase NA

What the Registry Record Tells You About NCT06817226

The ClinicalTrials.gov registry entry for NCT06817226 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pre-survey is the first listed.

NCT06817226 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT06817226 about?

NCT06817226 is a clinical study titled "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 Lati...

What is the current status of trial NCT06817226?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-10-10. Estimated completion is 2026-08-28.

What conditions does trial NCT06817226 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT06817226?

The interventions under investigation include: Pre-survey (BEHAVIORAL), BREASTChoice tool. (BEHAVIORAL), Post-survey (BEHAVIORAL).

Who is sponsoring clinical trial NCT06817226?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06817226 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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