Clinical trial NCT05574478: Metastatic Breast Cancer-Specific Prognostic Tool
Official title: Evaluation of the Acceptability, Appropriateness, Feasibility and Utility of a Metastatic Breast Cancer-Specific Prognostic Tool Among Patients With Metastatic Breast Cancer and Their Caregivers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Breast Cancer
Keywords: Patients
End of life
Caregivers
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
name: Doris Duke Charitable Foundation
First posted: 2022-10-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients diagnosed with metastatic breast cancer and/or caregivers of patients diagnosed with metastatic breast cancer. 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: In 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 20-30 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. In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.
2. Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
3. Diagnosis of metastatic breast cancer or primary caregiver for someone with a diagnosis of metastatic breast cancer
4. Age \> 18 years
5. Verbal informed consent obtained to participate in the study.
6. Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

Exclusion Criteria:

1. Non-English speaking

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Primary outcomes:
measure: Determining the key patient and caregiver factors impacting implementation of a metastatic breast cancer prognostic tool through semi-structured qualitative interviews.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Terri Eubanks
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Emily Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: