Metastatic Breast Cancer-Specific Prognostic Tool

Last updated: August 1, 2025
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Metastatic Cancer

Breast Cancer

Treatment

Patients and Caregivers Qualitative Interview

Clinical Study ID

NCT05574478
LCCC2213
  • Ages > 18
  • All Genders

Study Summary

In this qualitative study, Investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. These interviews will be conducted by the UNC CHAI Core and will continue until thematic saturation (estimated 20-30 participants). The investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the Consolidated Framework for Implementation Research (CFIR). The information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. In order to participate in this study a subject must meet ALL of the eligibilitycriteria outlined below.

  2. Subjects is willing and able to comply with study procedures based on the judgementof the investigator or protocol designee.

  3. Diagnosis of metastatic breast cancer or primary caregiver for someone with adiagnosis of metastatic breast cancer

  4. Age > 18 years

  5. Verbal informed consent obtained to participate in the study.

  6. Subject is willing and able to comply with study procedures based on the judgementof the investigator or protocol designee.

Exclusion

Exclusion Criteria:

  1. Non-English speaking

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: Patients and Caregivers Qualitative Interview
Phase:
Study Start date:
September 20, 2022
Estimated Completion Date:
February 28, 2024

Study Description

If this study is successful, Investigators will implement an MBC-specific prognostic tool to help clinicians identify patients who are at high risk of death in the next 30 days. Based on the input from clinicians in this proposal, as well as additional qualitative studies with patients and families, Investigators will design an implementation protocol to inform how to use this tool in clinical practice. Rather than simply publishing a prognostic tool that may not be adopted into practice, this project aims to ensure successful implementation of an evidence-based tool into the routine care of patients with MBC. Doing so will serve as an important step towards identifying high-risk patients and connecting ort to ensure high-quality, patient-centered end-of-life care.

Connect with a study center

  • Terri Eubanks

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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