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

NCT06855654 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Promoting Resilience in Women with Breast Cancer (PRISM)

PRISM is a brief, skills-based intervention targeting 4 core resilience resources (stress management, goal setting, cognitive reframing, and meaning-making) followed by an optional family session. This adapted version of the PRISM intervention will be delivered1:1 by trained coaches who speak English or Spanish via HIPAA-compliant video conference.A single coach conducts the program with a single patient. Each session is 30-60 minutes, for a total of 2- 4 hours. Sessions are delivered every 1-2 weeks per patient's preference. To facilitate on-demand skills-practice between sessions, all participants have access to the PRISM app, available for iOS/Android, and thus available to the \>90% of U.S. adults who own a smartphone. Participants will be assisted to download the PRISM app to their device at the time of registration; however, coaches can also provide assistance with app access during intervention sessions.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Katie Reeder-Hayes, MD, MBA, MSCR · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855654 on ClinicalTrials.gov