Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
NCT ID: NCT05452681
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
30 participants
INTERVENTIONAL
2022-06-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Y-AMBIENT
Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. All themed education and follow-up sessions are conducted according to the respective Y-AMBIENT session outlines and audio-recorded. Session 1, titled "My Self, My Soul," covers topics related to spiritual growth and finding meaning in illness. Session 2, titled "My Body," covers topics related to breast changes, aches/pains, fatigue, and weight changes. Session 3, titled "My Mind and My Relationships," covers topics related to anxiety, fear, and relationships with others. The sessions will take approximately one hour, with follow-ups lasting about 20 minutes. Participants will receive both printed and electronic PDF versions of written materials, in addition to video links, to reinforce content delivered during Sessions.
Educational Intervention
Receive Y-AMBIENT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Attention Control
The control condition will consist of receiving a culturally-targeted cookbook applied by an adapted "Food for Thought" cookbook, a guide to grocery shopping smart, and telephone socialization calls. We opted to use the cookbook and guide as conversation pieces given cultural practices associated with food and avert financial constraints with shopping tips. During three, one-hour socialization calls, we will use scripted questions to encourage discussion about the participant, cookbook and guide, and obtain information about survivorship concerns without providing coaching. The follow-up calls will last about 20 minutes.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Control Intervention
Receive cookbook and socialization calls
Interventions
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Educational Intervention
Receive Y-AMBIENT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Control Intervention
Receive cookbook and socialization calls
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
* 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
18 Years
44 Years
FEMALE
No
Sponsors
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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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Other Identifiers
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IRB-300012133
Identifier Type: -
Identifier Source: org_study_id
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