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Metastatic Breast Cancer-Specific Prognostic Tool

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05574478
Enrollment
19
Registered
2022-10-10
Start date
2022-09-20
Completion date
2024-02-28
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Patients, End of life, Caregivers

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.

Interventions

BEHAVIORALPatients and Caregivers 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.

Sponsors

Conquer Cancer Foundation
CollaboratorOTHER
Doris Duke Charitable Foundation
CollaboratorOTHER
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Determining the key patient and caregiver factors impacting implementation of a metastatic breast cancer prognostic tool through semi-structured qualitative interviews.12 monthsStudy 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 factors impacting implementation of a MBC prognostic tool will be evaluated through semi-structured qualitative interviews with patients and caregivers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026