Contemporary clinical trials · 2026
The FYI on MRI: Protocol for a randomized, parallel-group superiority trial of a multilevel decision support intervention to increase informed decision-making about screening breast MRI among high-risk black and Latina women.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Conley Claire C, Mills Mary Gleason, Dash Chiranjeev, Luta George, Song Judy H, Isaacs Claudine, Graves Kristi D, O'Neill Suzanne C
Аннотация
BACKGROUND: Women at high risk for breast cancer (i.e., estimated lifetime risk ≥20%) should receive annual mammography and consider supplemental screening breast MRI. However, high-risk Black and Latina women face substantial barriers to both risk identification and MRI awareness. This trial will assess the efficacy of a multilevel decision support intervention to increase informed decisions about screening breast MRI among high-risk Black and Latina women.
METHODS: Adult females ages 18-74 who identify as Black and/or Latina and have an estimated lifetime breast cancer risk ≥20% as identified through universal risk assessment will be recruited following a routine screening mammogram with normal results. After completing a baseline survey (T0), participants will be randomly assigned to receive either (1) a culturally-relevant breast MRI decision aid or (2) an enhanced usual care letter indicating eligibility for screening breast MRI. Randomization will be stratified by race and ethnicity (non-Hispanic Black, Hispanic Black, other Hispanic) to ensure balance across study groups. The primary outcome is informed decision about breast MRI at the 1-month follow-up (T1). Secondary outcomes include decision satisfaction and decisional conflict. Receipt of screening breast MRI at the 6-month follow-up (T2) assessed via electronic medical record review is an exploratory outcome.
CONCLUSION: This study is well-positioned to evaluate the impact of a culturally relevant decision aid above and beyond the effect of universal risk assessment and identification alone. If demonstrated to increase informed decisions, this intervention framework can be translated to any new preference-sensitive, risk-based cancer screening modality.
CLINICAL TRIALS REGISTRATION NUMBER: NCT06892275.
METHODS: Adult females ages 18-74 who identify as Black and/or Latina and have an estimated lifetime breast cancer risk ≥20% as identified through universal risk assessment will be recruited following a routine screening mammogram with normal results. After completing a baseline survey (T0), participants will be randomly assigned to receive either (1) a culturally-relevant breast MRI decision aid or (2) an enhanced usual care letter indicating eligibility for screening breast MRI. Randomization will be stratified by race and ethnicity (non-Hispanic Black, Hispanic Black, other Hispanic) to ensure balance across study groups. The primary outcome is informed decision about breast MRI at the 1-month follow-up (T1). Secondary outcomes include decision satisfaction and decisional conflict. Receipt of screening breast MRI at the 6-month follow-up (T2) assessed via electronic medical record review is an exploratory outcome.
CONCLUSION: This study is well-positioned to evaluate the impact of a culturally relevant decision aid above and beyond the effect of universal risk assessment and identification alone. If demonstrated to increase informed decisions, this intervention framework can be translated to any new preference-sensitive, risk-based cancer screening modality.
CLINICAL TRIALS REGISTRATION NUMBER: NCT06892275.