Clinical trial NCT05452681: Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
Official title: Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of screen-eligible patients enrolled by consent
timeFrame: Up to 2 years
measure: Proportion of patients that complete all (five) study contacts of intervention
timeFrame: Up to 2 years
measure: Acceptability/Relevance of Intervention Sessions
timeFrame: Up to 2 years
measure: Participation in aspects of protocol
timeFrame: Up to 2 years
measure: Use of proposed self-management strategies and perceived effectiveness
timeFrame: Up to 2 years
measure: Medical Outcomes Survey Short-Form (SF-36)
timeFrame: Baseline up to 1 month post-intervention
measure: PROMIS Global Health10
timeFrame: Baseline up to 1 month post-intervention
measure: (Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)
timeFrame: Baseline up to 1 month post-intervention
measure: MOS Modified Social Support Survey
timeFrame: Baseline up to 1 month post-intervention
measure: PROMIS Applied Cognition - General Concerns short form (8- item)
timeFrame: Baseline up to 1 month post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Timiya Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
References: