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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.

Primary Outcome

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.

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 NCT06817226 shows while recruiting

NCT06817226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06817226's enrollment target sits among peer trials

50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06817226, the US trial registry maintained by the National Library of Medicine. NCT06817226 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.