NCT05243056

A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the use of a quality of life intervention called Y-AMBIENT to help young African American with stage I-III breast cancer manage daily life. Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.

Detailed description

PRIMARY OBJECTIVES: 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

• 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	Best Practice	Receive enhanced usual care
OTHER	Educational Intervention	Receive Y-AMBIENT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-02-16
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States