Actively Recruiting
Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients
Led by Ohio State University Comprehensive Cancer Center ยท Updated on 2026-02-11
40
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if patients with triple negative breast cancer can complete a ten-week biobehavioral stress reduction program that also addresses health-related social needs such as utilities and transportation. The study focuses on understanding the acceptability, tolerability, and feasibility of this program in patients with stages I to III triple negative breast cancer. Researchers will assess stress levels reported by patients as well as biological markers related to stress and overall health. Participants will receive a biobehavioral stress reduction intervention that includes techniques like progressive muscle relaxation, coping strategies, problem solving, communication, and social support. Health-related social needs are assessed at the start, and referrals to social work are provided as needed. Blood samples will be collected at baseline and follow-up visits, and medical records will be reviewed during the study. During the study, participants will complete surveys including the Client Satisfaction Questionnaire and Profile of Mood States to evaluate treatment satisfaction and mood changes. Researchers will also measure various biomarkers such as white blood cell count, C-reactive protein, interleukin-6, TNF-alpha, blood pressure, heart rate, cholesterol levels, hemoglobin A1C, and body mass index. These assessments will help examine the effects of the intervention on stress, mood, psychological symptoms, and allostatic load over a period of up to two years.
CONDITIONS
Brief Title
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >=18 years
- Female with newly diagnosed untreated triple negative breast cancer
- Breast cancer stage I, II, or III
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive a biobehavioral stress reduction intervention while on study.
10 intervention sessions
Duration - Up to 2 years
Participants undergo blood specimen collection at baseline and follow-up visits and have their medical records reviewed to assess biomarkers and other health indicators.
2 visits (baseline and follow-up)
Trial Site Locations
Total: 2 locations
1
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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