Promoting resilience in Black women with metastatic breast cancer
Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC)
This study is testing a new program to see if it can help Black women with metastatic breast cancer feel stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06855654 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study evaluates the effectiveness of the Promoting Resilience in Women with Breast Cancer (PRISM) intervention on resilience and patient-reported outcomes in Black women diagnosed with metastatic breast cancer. The study aims to assess changes from baseline to post-intervention, focusing on the unique challenges faced by this population due to adverse social determinants of health. It also seeks to determine the feasibility and acceptability of the intervention among participants. By addressing both psychological and social factors, the study hopes to improve quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are Black women aged over 18 who have been diagnosed with metastatic breast cancer within the last 182 days.
Not a fit: Patients who do not identify as Black or those who are not diagnosed with metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance resilience and quality of life for Black women with metastatic breast cancer.
How similar studies have performed: Other studies have shown promise in addressing resilience and quality of life in cancer patients, but this specific approach focusing on Black women with metastatic breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Participants are willing and able to comply with study procedures based on the judgement of the investigator. * Male and female patients of age \>18 years. * Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date. * Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English). * Indicate intent to receive ongoing cancer care at the enrolling institution. Exclusion Criteria: Individuals meeting any of the following exclusion criteria will be excluded from study participation. * Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer. * Patient unwilling or unable to provide verbal or signed consent to participate. * Participant cannot read English. * Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.
Where this trial is running
Birmingham, Alabama and 1 other locations
- The University of Alabama — Birmingham, Alabama, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katie Reeder-Hayes, MD, MBA, MSCR — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Erin Laurie-Zehr
- Email: erin_laurie@med.unc.edu
- Phone: (919)-445-4941
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.