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The purpose of this two-arm pilot RCT is to evaluate processes and preliminary outcomes of a targeted QOL intervention vs. an attention control among young AA survivors post-treatment for early (I-II) \& late (III) stage breast cancer.
Primary Objectives I. Evaluate feasibility and acceptability of Y-AMBIENT and an attention control among young African American breast cancer survivors. II. Explore the degree to which the Y-AMBIENT vs. attention control affects preliminary health-related outcomes among young African American (AA) survivors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (Y-AMBIENT): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4. ARM II (ATTENTION CONTROL): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4. After completion of study, patients are followed up at 1 month.
Age
18 - 44 years
Sex
FEMALE
Healthy Volunteers
No
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
June 1, 2022
Primary Completion Date
December 30, 2025
Completion Date
December 31, 2025
Last Updated
August 1, 2025
30
ESTIMATED participants
Educational Intervention
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Control Intervention
OTHER
The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066OSUCCCClinicaltrials@osumc.eduLead Sponsor
University of Alabama at Birmingham
NCT05245812
NCT05673200
Data Source & Attribution
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