Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Negative Breast Carcinoma, Triple-Negative Breast Carcinoma
Conditions
Brief 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHERMedical Chart Review
Undergo medical cart review
PROCEDUREStress Management Therapy
Receive biobehavioral stress reduction intervention
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTThe Ohio State Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORSamilia Obeng-Gyasi, MD, MPH
Ohio State University Comprehensive Cancer Center
Outcome results
None listed