A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment
NCT ID: NCT05243056
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-06-01
2025-12-30
Brief Summary
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Detailed Description
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I. Evaluate feasibility and acceptability of Y-AMBIENT and enhanced usual care among young African American breast cancer survivors.
II. Explore the degree to which the Y-AMBIENT versus (vs.) enhanced usual care 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 (ENHANCED USUAL CARE): Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.
After completion of study, patients are followed up at 1 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Educational Intervention
Receive Y-AMBIENT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (enhanced usual care)
Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.
Best Practice
Receive enhanced usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive enhanced usual care
Educational Intervention
Receive Y-AMBIENT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Self-identify as AA
* Are aged 18 to 44 years on study entry
* Are diagnosed with breast cancer stage I-III
* Are in treatment with chemotherapy and/or radiation for stage I-III breast cancer at study entry
* Are English- speaking
* Have telephone and internet access
Exclusion Criteria
18 Years
44 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Timiya Nolan
Principal Investigator
Principal Investigators
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Timiya Nolan, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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NCI-2021-02286
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-300012132
Identifier Type: -
Identifier Source: org_study_id
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