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RecruitingNCT05440929Updated Sep 24, 2025

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

An observational study in Metastatic Breast Cancer and End of Life, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
15
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metastatic Breast Cancer
  • End of Life

Keywords

  • Metastatic Breast Cancer
  • Prognostic Tool
  • End of life
  • Clinicians
  • Prognosis
  • Qualitative Interview
  • Caregivers
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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).

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

Exclusion Criteria:

  • Non-English Speaking
04

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralClinician 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT05440929
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Conquer Cancer Foundation
Responsible party
Sponsor
First posted
Jul 1, 2022
Start date
Jul 7, 2022
Primary completion
Aug 10, 2027 (estimated)
Completion
Aug 10, 2027 (estimated)
Last update
Sep 24, 2025

Study contacts

Terri Eubanks, BSBA
Contact
teubanks@med.unc.edu
919-966-4530
Erin Kelly, MPH, RD, LDN
Contact
erin_kelly@med.unc.edu
919-966-0040
Emily Ray, MD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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