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

The Ohio State University

Status: Enrolling

Conditions: Anatomic Stage III Breast Cancer AJCC V8; HER2-Negative Breast Carcinoma; Triple-Negative Breast Carcinoma; Anatomic Stage II Breast Cancer AJCC V8; Anatomic Stage I Breast Cancer AJCC V8; Hormone Receptor-Negative Breast Carcinoma

Treatments: Other: Survey Administration; Procedure: Stress Management Therapy; Procedure: Biospecimen Collection; Other: Medical Chart Review

Study type: Interventional

Funder types: Other

Identifiers

NCT05677802

OSU-22083

NCI-2022-08781 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Health Services Research (stress management therapy)

Experimental group

Description:

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.

Treatment:

Other: Medical Chart Review

Procedure: Stress Management Therapy

Procedure: Biospecimen Collection

Other: Survey Administration