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Biobehavioral Stress Reduction for Triple Negative Breast Cancer

This study is looking at whether a stress reduction program can help patients with newly diagnosed triple negative breast cancer (stages I-III). The program, called a biobehavioral stress reduction intervention, lasts ten weeks and includes techniques like progressive muscle relaxation, coping skills, and communication strategies. It also helps address social needs like transportation or utilities by connecting you with social work. Researchers will look at how satisfied you are with the program, your mood, and also collect blood samples to check for biological markers related to stress. The goal is to see if this type of program is practical and helpful for patients.

Study design
This is an interventional study with an estimated enrollment of 40 women. It is not specified if it is randomized or blinded.
What's involved
You would receive the biobehavioral stress reduction intervention, which is a 10-week program. You would also have blood samples collected, medical chart reviews, and complete surveys.
Compensation
Not stated in the trial record.
Follow-up
Your satisfaction, mood, and participation in the intervention will be measured for up to 2 years.

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NCT05677802

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

Recruiting
NAAges 18+InterventionalHealth services
Ohio State University Comprehensive Cancer Center
~40 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMedical Chart ReviewStress Management TherapySurvey Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participant Satisfaction with the Biobehavioral Intervention
Measured over Up to 2 years
+2 more outcomes measured

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

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Breast Carcinoma

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Samilia Obeng-Gyasi, MD, MPH · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>=18 years
Untreated newly diagnosed triple negative breast cancer
Stages I-III

Exclusion

Prisoners
Male
Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander
Individuals not able to speak and understand English
Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer
Stage IV breast cancer

What this trial measures

  • Participant Satisfaction with the Biobehavioral InterventionUp to 2 years

    Acceptability will be measured at the end of the intervention using the Client Satisfaction Questionnaire (CSQ). CSQ scores range from 8-32 with higher scores indicating higher satisfaction.

  • Profile of Mood States for the Biobehavioral InterventionUp to 2 years

    This will be assessed analyzing pre to post treatment change on the Profile of Mood States short form. The Profile of Mood States short from is a 37 item survey with lower scores indicative of stable mood.

  • Participant Biobehavioral InterventionUp to 2 years

    Feasibility will be evaluated using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each Biobehavioral intervention (BBI) session; and, 3) number/percent of patients retained and completing 10 BBI sessions.