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

NCT ID: NCT05243056

Last Updated: 2025-08-01

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive Y-AMBIENT

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive enhanced usual care

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive enhanced usual care

Intervention Type OTHER

Educational Intervention

Receive Y-AMBIENT

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Quality of Life Assessment

Eligibility Criteria

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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
* Are in treatment with chemotherapy and/or radiation for stage I-III breast cancer at 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Timiya Nolan

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

800-293-5066

Facility Contacts

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Timiya Nolan

Role: primary

614-292-4482

Related Links

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Other Identifiers

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K08CA245208

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-02286

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-300012132

Identifier Type: -

Identifier Source: org_study_id

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