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NCT Number: NCT05440929

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Death End of Life Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Emily Ray, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Non-English Speaking

Treatment and study plan

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.

Primary outcomes

  1. Key barriers for use a metastatic breast cancer-specific prognostic tool

    Time frame: 12 months

    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.

  2. Key facilitators for use of a metastatic breast cancer-specific prognostic tool

    Time frame: 12 months

    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.

Secondary outcomes

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

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Kelly, MPH, RD, LDN

CONTACT

[email protected]

919-966-0040

Terri Eubanks, BSBA

CONTACT

[email protected]

919-966-4530

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Conquer Cancer Foundation

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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