This clinical trial evaluates the feasibility of delivering a biobehavioral stress reduction intervention for reducing stress levels in patients with stage I-III triple negative breast cancer. Patients with triple negative breast cancer have been shown to have higher rates of death due to adverse social aspects of health. Stress in particular results in suppression of the immune response, which can prevent wound healing and intensify tumor progression. This biobehavioral stress reduction intervention includes muscle relaxation techniques, coping skills, as well as problem solving and social support sessions, which may help improve health outcomes in this population of cancer patients.
Additional locations may be listed on ClinicalTrials.gov for NCT05677802.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Samilia Obeng-Gyasi
Phone: 614-293-6408
PRIMARY OBJECTIVES:
I. To determine the feasibility, treatment adherence of a biobehavioral stress reduction intervention tailored to patients with triple negative breast cancer at the Stefanie Spielman Comprehensive Cancer Center (SSCBC).
II. Additionally, the mode of delivery (in person, virtual), frequency of contact, and duration of contacts will be studied to identify efficiencies to achieve implementation.
SECONDARY OBJECTIVE:
I. To examine the feasibility of collecting biomarkers––anthropometric data and labs, to calculate allostatic load, a biological correlate of stress.
EXPLORATORY OBJECTIVE:
I. To test for pre/post effects of the biobehavioral stress reduction intervention on measures of stress (Impact of Events Scale), mood and psychological symptoms, and allostatic load.
OUTLINE:
Patients receive biobehavioral stress reduction intervention in 10 sessions over 10-weeks while on study. Patients undergo blood specimen collection at baseline and follow up and have their medical records reviewed.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSamilia Obeng-Gyasi
