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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; End of Life
• Intervention / Treatment: Behavioral: Clinician Qualitative Interview

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.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Terri Eubanks, BSBA; Phone Number: 919-966-4530; Email: teubanks@med.unc.edu
• Study Contact Backup: Name: Erin Kelly, MPH, RD, LDN; Phone Number: 919-966-0040; Email: erin_kelly@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: Emily Ray, MD; Email: emily_ray@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Clinician participants will include physicians, nurse practitioners, physician assistants, and nurse navigators. 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Clinicans; Participants will include: physicians, nurse practitioners, physician assistants, and nurse navigators. 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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Conquer Cancer Foundation
• Investigators: Principal Investigator: Emily Ray, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): August 10, 2027

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Caregivers; Metastatic Breast Cancer; End of life; Qualitative Interview; Prognostic Tool; Clinicians
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Death
• Other Study ID Numbers: LCCC2207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No