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

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.

• Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection: Undergo blood sample collection
• Medical Chart Review (Other), also known as Chart Review: Undergo medical cart review
• Stress Management Therapy (Procedure): Receive biobehavioral stress reduction intervention
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Participant Satisfaction with the Biobehavioral Intervention [Up 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 Intervention [Up 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 Intervention [Up 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.

Secondary outcomes

• Biomarkers for allostatic load [Up to 2 years]: The points for each biomarker will be summarized into a total score ranging from 0-12. The pre-test allostatic load biomarker will be based on the distribution of each biomarker within the study sample at diagnosis. For each biomarker, each patient will be stratified into quartiles. A point will be assigned for membership in the worst quartile. The post-test allostatic load will be calculated similar to the pre-test allostatic load using biomarkers collected after the intervention.

Sex: Female, ages: 18 Years to any

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

• Samilia Obeng-Gyasi, MD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center