Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05440929

Conditions

Metastatic Breast Cancer

End of Life

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Clinician Qualitative Interview

Study Details

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

Study ID

NCT05440929

Start date

Jul 7, 2022

Status verified date

Sep, 2025

Completion date

Aug 10, 2027

Anticipated

Primary completion date

Aug 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

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.

Primary outcome measure

  • Key barriers for use a metastatic breast cancer-specific prognostic tool [ Time Frame: 12 months ]
  • Key facilitators for use of a metastatic breast cancer-specific prognostic tool [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Terri Eubanks, BSBA

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

Erin Kelly, MPH, RD, LDN

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

Locations

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Emily Ray, MD

emily_ray@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-09-24.