RecruitingNot ApplicableNCT05677802

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

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERMedical Chart Review

Undergo medical cart review

PROCEDUREStress Management Therapy

Receive biobehavioral stress reduction intervention

OTHERSurvey Administration

Ancillary studies


Locations(2)

MetroHealth

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT05677802


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