RecruitingNot ApplicableNCT06855654

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

Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC)


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

120 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a counseling program called PRISM (Promoting Resilience in Stress Management) designed to help people recently diagnosed with metastatic breast cancer (cancer that has spread to other parts of the body) build emotional resilience and improve their quality of life. **You may be eligible if:** - You are 18 years or older (male or female) - You have been diagnosed with metastatic breast cancer within the last 6 months - You intend to continue receiving cancer care at the enrolling hospital - You can respond to surveys and counseling sessions in English **You may NOT be eligible if:** - You are unable or unwilling to complete surveys (by paper or electronically) - You cannot read English - You are currently in hospice care or are not receiving any cancer treatment - You are expected to die within 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPromoting 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.


Locations(2)

The University of Alabama

Birmingham, Alabama, United States

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT06855654


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