Metastatic Breast Cancer-Specific Prognostic Tool

NCT05574478 | Completed

• 1 other identifier: LCCC2213
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Patients; End of life; Caregivers

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Study Arms (1)

Patients and Caregivers

Participants will include patients diagnosed with metastatic breast cancer and caregivers for 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).

Behavioral: Patients and Caregivers Qualitative Interview

Interventions

Patients and Caregivers Qualitative Interview BEHAVIORAL

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.

Patients and Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• \. Non-English speaking

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Conquer Cancer Foundation: collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Terri Eubanks

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms; Death

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Ray, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: September 20, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

US (1)