Clinical trial NCT05440929: Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians
Official title: Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Breast Cancer
End of Life
Keywords: Metastatic Breast Cancer
Prognostic Tool
End of life
Clinicians
Prognosis
Qualitative Interview
Caregivers
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2022-07-01
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Key barriers for use a metastatic breast cancer-specific prognostic tool
timeFrame: 12 months
measure: Key facilitators for use of a metastatic breast cancer-specific prognostic tool
timeFrame: 12 months
Secondary outcomes:
measure: Key barriers for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer
timeFrame: 12 months
measure: Key facilitators for discussion of prognosis between oncology clinicians and patients with metastatic breast cancer
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: