Biobehavioral stress reduction for patients with triple negative breast cancer
Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients
This study is testing a stress reduction program for people who have just been diagnosed with triple negative breast cancer to see if it helps them feel better and cope with their situation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT05677802 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of a biobehavioral stress reduction program for patients with newly diagnosed triple negative breast cancer. Over ten weeks, participants will engage in stress reduction techniques, coping strategies, and receive support for health-related social needs. The study will assess patient satisfaction, tolerability, and feasibility through various metrics, including completion rates and biological markers related to stress. Additionally, the impact on psychological symptoms and stress levels will be explored through pre- and post-intervention assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated, newly diagnosed triple negative breast cancer at stages I-III.
Not a fit: Patients with a history of invasive breast cancer or stage IV breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help reduce stress and improve overall well-being in patients with triple negative breast cancer.
How similar studies have performed: While the specific approach may be novel, similar studies have shown that stress reduction interventions can positively impact cancer patients' quality of life.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio and 1 other locations
- MetroHealth — Cleveland, Ohio, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Samilia Obeng-Gyasi, MD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.