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NCT06855654 · ClinicalTrials.gov registry record · NA

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

A NA study of Breast Cancer and Metastatic Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
NA
Development phase
120
Enrollment target
2
Study locations

NCT06855654 is a NA study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 120 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06855654, a NA study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
NA
Development phase
120 participants
Enrollment target
2
Study locations

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.

Interventions

  • BEHAVIORAL Promoting Resilience in Women with Breast Cancer (PRISM)

Study Locations (2)

Alabama

  • The University of Alabama - Birmingham

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-01-01
Est. Completion 2027-12-01
Phase NA

What the Registry Record Tells You About NCT06855654

The ClinicalTrials.gov registry entry for NCT06855654 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Promoting Resilience in Women with Breast Cancer (PRISM) is the first listed.

NCT06855654 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06855654 about?

NCT06855654 is a clinical study titled "Promoting Resilience in Women With Breast Cancer (PRISM -MBC)". 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) interventi...

What is the current status of trial NCT06855654?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-01-01. Estimated completion is 2027-12-01.

What conditions does trial NCT06855654 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer.

What interventions are being tested in trial NCT06855654?

The interventions under investigation include: Promoting Resilience in Women with Breast Cancer (PRISM) (BEHAVIORAL).

Who is sponsoring clinical trial NCT06855654?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06855654 being conducted?

This trial has 2 study locations across Alabama, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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