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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT05677802
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Medical Chart Review — OTHER
    Undergo medical cart review
  • Stress Management Therapy — PROCEDURE
    Receive biobehavioral stress reduction intervention
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Dec 14, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Participant Satisfaction with the Biobehavioral Intervention [ Time Frame: Up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MetroHealthClevelandOhio44109
Natalie Joseph, MD
216-778-7800
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Samilia Obeng-Gyasi, MD, MPH
[email protected]
614-293-6408
Samilia Obeng-Gyasi, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
MetroHealth· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OH

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