Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06855654

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-05-07

120

Participants Needed

2

Research Sites

152 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent and HIPAA authorization
  • Willing and able to comply with study procedures
  • Male or female aged over 18 years
  • Diagnosed with metastatic breast cancer within 182 days before enrollment
  • Able to answer surveys and participate in counseling sessions in English
  • Intend to receive ongoing cancer care at the enrolling institution
Not Eligible

You will not qualify if you...

  • Unable or unwilling to complete surveys via paper or electronic methods
  • Unable or unwilling to provide verbal or signed consent
  • Cannot read English
  • Have permanently stopped cancer-directed therapy, are in hospice care, hospitalized, or expected to die within 90 days according to provider documentation

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The University of Alabama

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

E

Erin Laurie-Zehr

CONTACT

K

Kacee Little

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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