Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT05677802

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Medical Chart Review

Stress Management Therapy

Survey Administration

Study Details

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

Study ID

NCT05677802

Start date

Dec 14, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Medical Chart Review

Undergo medical cart review

Stress Management Therapy

Receive biobehavioral stress reduction intervention

Survey Administration

Ancillary studies

Primary outcome measure

  • Participant Satisfaction with the Biobehavioral Intervention [ Time Frame: Up to 2 years ]
  • Profile of Mood States for the Biobehavioral Intervention [ Time Frame: Up to 2 years ]
  • Participant Biobehavioral Intervention [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Natalie Joseph, MD

216-778-7800

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Samilia Obeng-Gyasi, MD, MPH

614-293-6408samilia.obeng-gyasi@osumc.edu

Principal Investigator:

Samilia Obeng-Gyasi, MD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-29.