Back to Trials
NCT05677802NARecruiting

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

Ohio State University Comprehensive Cancer Center

Start Date

12/14/2022

Completion Date

6/30/2027

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.

Detailed Description

PRIMARY OBJECTIVES: I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire (CSQ). CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction (e.g., quality of service, the degree to which needs were met, overall satisfaction). III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States. III Feasibility of the biobehavioral intervention will be assessed using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each BBI session; and, 3) number/percent of patients retained and completing 10 BBI sessions. SECONDARY OBJECTIVE: I. To examine the feasibility of collecting biomarkers--white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI). 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 while on study. Patients undergo blood specimen collection at baseline and follow up, and have their medical records reviewed.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age \>=18 years * Untreated newly diagnosed triple negative breast cancer * Stages I-III Exclusion Criteria: * 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

Interventions

PROCEDURE

Biospecimen Collection

OTHER

Medical Chart Review

PROCEDURE

Stress Management Therapy

OTHER

Survey Administration

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Negative Breast CarcinomaHormone Receptor-Negative Breast CarcinomaTriple-Negative Breast Carcinoma

Locations

MetroHealth

Cleveland, Ohio 44109

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States