Clinical trial NCT05677802: Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
Official title: Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Satisfaction with the Biobehavioral Intervention
timeFrame: Up to 2 years
measure: Profile of Mood States for the Biobehavioral Intervention
timeFrame: Up to 2 years
measure: Participant Biobehavioral Intervention
timeFrame: Up to 2 years
Secondary outcomes:
measure: Biomarkers for allostatic load
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Samilia Obeng-Gyasi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: