NCT06855654 Promoting Resilience in Women With Breast Cancer (PRISM -MBC)
| NCT ID | NCT06855654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population. Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.
Eligibility 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.
Contact & Investigator
Katie Reeder-Hayes, MD, MBA, MSCR
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06855654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855654 currently recruiting?
Yes, NCT06855654 is actively recruiting participants. Contact the research team at erin_laurie@med.unc.edu for enrollment information.
Where is the NCT06855654 trial being conducted?
This trial is being conducted at Birmingham, United States, Chapel Hill, United States.
Who is sponsoring the NCT06855654 clinical trial?
NCT06855654 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Katie Reeder-Hayes, MD, MBA, MSCR at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 120 participants.
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