Promoting Resilience in Women With Breast Cancer (PRISM -MBC)

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Metastatic Breast Cancer

In brief

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.

Key facts

Study ID: NCT06855654
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 120
Starts: 2025-01-01
Expected to finish: 2027-12-01
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

The University of Alabama — Birmingham, Alabama, United States (enrolling)
University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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