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Clinical Trials/NCT05574478
NCT05574478
Completed
Not Applicable

Evaluation of the Acceptability, Appropriateness, Feasibility and Utility of a Metastatic Breast Cancer-Specific Prognostic Tool Among Patients With Metastatic Breast Cancer and Their Caregivers

UNC Lineberger Comprehensive Cancer Center1 site in 1 country19 target enrollmentSeptember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Breast Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
19
Locations
1
Primary Endpoint
Determining the key patient and caregiver factors impacting implementation of a metastatic breast cancer prognostic tool through semi-structured qualitative interviews.
Status
Completed
Last Updated
9 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
February 28, 2024
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.
  • Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
  • Diagnosis of metastatic breast cancer or primary caregiver for someone with a diagnosis of metastatic breast cancer
  • Age \> 18 years
  • Verbal informed consent obtained to participate in the study.
  • Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

Exclusion Criteria

  • Non-English speaking

Outcomes

Primary Outcomes

Determining the key patient and caregiver factors impacting implementation of a metastatic breast cancer prognostic tool through semi-structured qualitative interviews.

Time Frame: 12 months

Study Investigators have developed a metastatic breast cancer (MBC)-specific prognostic calculator using the ASCO CancerLinQ Discovery database to help oncologists better estimate prognosis in MBC patients. Key factors impacting implementation of a MBC prognostic tool will be evaluated through semi-structured qualitative interviews with patients and caregivers.

Study Sites (1)

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