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

NCT ID: NCT05677802

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2026-01-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health Services Research (stress management therapy)

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Medical Chart Review

Intervention Type: OTHER

Undergo medical cart review

Stress Management Therapy

Intervention Type: PROCEDURE

Receive biobehavioral stress reduction intervention

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Medical Chart Review

Undergo medical cart review

Intervention Type: OTHER

Stress Management Therapy

Receive biobehavioral stress reduction intervention

Intervention Type: PROCEDURE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; Chart Review

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Samilia Obeng-Gyasi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samilia Obeng-Gyasi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

MetroHealth

Cleveland, Ohio, United States

Site Status: RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

The Ohio State Comprehensive Cancer Center

Role: CONTACT

OSUCCCClinicaltrials@osumc.edu

800-293-5066

Facility Contacts

Natalie Joseph, MD

Role: primary

216-778-7800

Samilia Obeng-Gyasi, MD, MPH

Role: primary

samilia.obeng-gyasi@osumc.edu

614-293-6408

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2022-08781

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-22083

Identifier Type: -

Identifier Source: org_study_id