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Trial Title:
Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer
NCT ID:
NCT05722847
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Advanced Cancer
High-Risk
patient reported outcome
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
This study explores whether supportive care interventions that might reduce
rehospitalization could be implemented and feasible, in subjects within a high-risk group
of subjects with newly diagnosed hospitalized advanced lung cancer (ALC).
This study screened 50 subjects from health records and consented to 15 of these screened
subjects. These 15 subjects responded to PRO questionnaires.
Detailed description:
Subjects will be considered high risk if they have small cell histology, longer than 8
days hospitalization, high comorbidity, emergency department use or hospitalization in
the previous 6 months, prescription of a wheelchair on hospital discharge, or Black
and/or Hispanic race. Supportive care interventions such as navigation and palliative
care will be recommended for this group.
All hospitalized subjects with newly diagnosed ALC will be offered web- or
telephone-based patient-reported outcome (PRO) symptom monitoring for 90 days following
hospital discharge if they provide consent. Medical record evaluation of consented
subjects will provide data for risk assessment and the high-risk group definition.
Healthcare utilization including emergency department visits, hospitalizations,
outpatient palliative care, and cancer treatment received will be compared.
Criteria for eligibility:
Study pop:
This study has 2 different populations: Patient participants and Health Care Providers.
Subjects with hospital-diagnosed advanced lung cancer must meet all of the eligibility
criteria, and Health Care Workers provide care to these subjects.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria for Patient Participants:
1. Age ≥ 18 years at the time of screening.
2. Hospital-diagnosed Advanced lung cancer with histological confirmation of disease or
suspected lung cancer in the opinion of the treating oncologist.
For PROs only
1. Able to complete a web-based or telephonic symptom survey.
Exclusion Criteria for Patient Participants:
1. Enrollment in hospice upon discharge from the index hospitalization For PROs only
1. Inability to read or speak English.
2. Dementia, altered mental status, or any psychiatric condition as determined by the
clinical or study team that would prohibit the understanding or rendering of
informed consent.
3. Current incarceration.
4. Any condition that would prohibit the patient from completing PROs
Inclusion Criteria for Health Care Provider Participants:
1. Thoracic medical oncology physicians, advance practice providers, and nurse
navigators work in the study site and respond to the survey that assesses
acceptability.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Start date:
March 14, 2023
Completion date:
May 2, 2025
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722847
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
