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

NCT05677802 | Recruiting DMC

• 2 other identifiers: OSU-22083NCI-2022-08781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Participant Satisfaction with the Biobehavioral Intervention

  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.

  Up to 2 years

• Profile of Mood States for the Biobehavioral Intervention

  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.

  Up to 2 years

• Participant Biobehavioral Intervention

  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.

  Up to 2 years

Secondary Outcomes (1)

• Biomarkers for allostatic load

  Up to 2 years

Study Arms (1)

Health Services Research (stress management therapy)

EXPERIMENTAL

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Health Services Research (stress management therapy)

Medical Chart Review OTHER

Undergo medical cart review

Also known as: Chart Review

Health Services Research (stress management therapy)

Stress Management Therapy PROCEDURE

Receive biobehavioral stress reduction intervention

Health Services Research (stress management therapy)

Survey Administration OTHER

Ancillary studies

Health Services Research (stress management therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years
• Untreated newly diagnosed triple negative breast cancer
• Stages I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (2)

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Samilia Obeng-Gyasi, MD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 10, 2023
• Study Start: December 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)