Metastatic Breast Cancer-Specific Prognostic Tool

Trial Title: Metastatic Breast Cancer-Specific Prognostic Tool

NCT ID: NCT05574478

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Patients
End of life
Caregivers

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Patients and Caregivers Qualitative Interview
Description: Interviews will be conducted by experienced qualitative researchers from the UNC Connected Health for Applications & Interventions (CHAI) Core. The interview will be conducted over the phone or secure videoconferencing. The interview will be conducted in a semi-structured fashion using an interview guide. However, because the purpose of this semi-structured qualitative interview study is to determine which themes participants identify as important, the exact content of each interview will differ, and the interview guide will be modified as additional interviews are conducted. Interviews will be audio recorded with concurrent notetaking by the interviewer.
Arm group label: Patients and Caregivers

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.

Detailed 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.

Criteria for eligibility:

Study pop:
Participants will be patients diagnosed with metastatic breast cancer and/or caregivers of patients diagnosed with metastatic breast cancer. Participants will be recruited from the UNC Medical Center breast oncology group as well as other practices identified by the Principal Investigator based on existing professional networks (referring physicians, other UNC oncology entities, collaborative groups).

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below. 2. Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. 3. Diagnosis of metastatic breast cancer or primary caregiver for someone with a diagnosis 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 judgement of the investigator or protocol designee. Exclusion Criteria: 1. Non-English speaking -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Terri Eubanks

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Start date: September 20, 2022

Completion date: February 2, 2026

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: Conquer Cancer Foundation
Agency class: Other

Collaborator:
Agency: Doris Duke Charitable Foundation
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05574478
http://unclineberger.org/patientcare/clinical-trials/clinical-trials