Breast Cancer Clinical Trial
Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Biologically born women
Self-identify as AA
Are aged 18 to 44 years on study entry
Are diagnosed with breast cancer stage I-III
Have completed treatment with chemotherapy and/or radiation for stage I-III breast cancer prior to study entry
Are English- speaking
Have telephone and internet access
Exclusion Criteria:
Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder
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There is 1 Location for this study
Columbus Ohio, 43210, United States More Info
Principal Investigator
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