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

NCT05440929 | Recruiting

• 1 other identifier: LCCC2207
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer; End of Life

Keywords

Metastatic Breast Cancer; Prognostic Tool; End of life; Clinicians; Prognosis; Qualitative Interview; Caregivers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Key barriers for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer

  12 months

• Key facilitators for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer

  12 months

Study Arms (1)

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

Interventions

Clinician 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.

Clinicans

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• Physician, nurse practitioner, physician assistant, or nurse navigator
• At least 6 months of experience in the clinical care of patients with metastatic breast cancer in the United States.

You may not qualify if:

• Non-English Speaking

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Conquer Cancer Foundation: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

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, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri Eubanks, BSBA

CONTACT

919-966-4530; teubanks@med.unc.edu

Erin Kelly, MPH, RD, LDN

CONTACT

919-966-0040; erin_kelly@med.unc.edu

Study Design

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

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 1, 2022
• Study Start: July 7, 2022
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): August 10, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)