RecruitingNot ApplicableNCT05677802

Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a mind-body stress reduction program for women newly diagnosed with triple-negative breast cancer — an aggressive subtype of breast cancer. Researchers want to see if reducing stress before and during treatment can improve patients' health outcomes. **You may be eligible if...** - You are a woman aged 18 or older - You have been newly diagnosed with triple-negative breast cancer (Stages I–III) and have not yet started treatment **You may NOT be eligible if...** - You identify as male - You identify as American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander (this pilot study is focused on a specific population) - You do not speak or understand English - You have a personal history of breast cancer (including DCIS) - You have Stage IV (metastatic) breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERMedical Chart Review

Undergo medical cart review

PROCEDUREStress Management Therapy

Receive biobehavioral stress reduction intervention

OTHERSurvey Administration

Ancillary studies


Locations(2)

MetroHealth

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05677802


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