NCT05452681

Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Educational Intervention	Receive Y-AMBIENT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Control Intervention	Receive cookbook and socialization calls

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2022-07-11
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States