Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians

Metastatic Breast Cancer Clinical Trial

Official title:

Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440929
• Other study ID #: LCCC2207
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: July 15, 2025

Study information

• Verified date: November 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Terri Eubanks, BSBA
• Phone: 919-966-4530
• Email: teubanks[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

I 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 10 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

2. Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

3. Physician, nurse practitioner, physician assistant, or nurse navigator

4. At least 6 months of experience in the clinical care of patients with metastatic breast cancer in the United States.

Exclusion Criteria:

• Non-English Speaking

Related Conditions & MeSH terms

• Breast Neoplasms
• Death
• End of Life
• Metastatic Breast Cancer

Intervention

Behavioral:
• Clinician Qualitative Interview
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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key barriers for use a metastatic breast cancer-specific prognostic tool	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 barriers using this metastatic breast cancer-specific prognostic tool will be identified, through semi-structured qualitative interviews with oncology clinicians.	12 months
Primary	Key facilitators for use of a metastatic breast cancer-specific prognostic tool	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 facilitators using this metastatic breast cancer-specific prognostic tool will be identified, through semi-structured qualitative interviews with oncology clinicians.	12 months
Secondary	Key barriers for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer	Key barriers for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer will be identified, through semi-structured qualitative interviews with oncology clinicians.	12 months
Secondary	Key facilitators for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer	Key facilitators for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer will be identified, through semi-structured qualitative interviews with oncology clinicians.	12 months