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A QoL Intervention for Young African American Breast Cancer Survivors

A QoL Intervention for Young African American Breast Cancer Survivors

Recruiting
18-44 years
Female
Phase N/A

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Overview

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.

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

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

Study details
    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

NCT05452681

Ohio State University Comprehensive Cancer Center

14 October 2025

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