Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
NCT05677802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-11
Summary
This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- HER2-Negative Breast Carcinoma
- Hormone Receptor-Negative Breast Carcinoma
- Triple-Negative Breast Carcinoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- OTHER
-
Medical Chart Review
Undergo medical cart review
- PROCEDURE
-
Stress Management Therapy
Receive biobehavioral stress reduction intervention
- OTHER
-
Survey Administration
Ancillary studies
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Samilia Obeng-Gyasi, MD, MPH · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-14
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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