Clinical trial NCT05722847: Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer
Official title: Development of an Enhanced Risk Stratification System for Patients With Hospital-diagnosed Advanced Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Advanced Cancer
High-Risk
patient reported outcome
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Success of the risk-based stratification system implementation - contacted
timeFrame: Up to 5 days
measure: Success of the risk-based stratification system implementation - referred
timeFrame: Up to 5 days
measure: Success of the risk-based stratification system implementation - navigation
timeFrame: Up to 16 days
measure: Success of the risk-based stratification system implementation - palliative care
timeFrame: Up to 16 days
Secondary outcomes:
measure: Time to receipt of outpatient palliative care
timeFrame: Up to 90 days
measure: Acceptability of the supportive care intervention
timeFrame: Up to 180 days
measure: Acceptability of the risk stratification system the time to complete for providers
timeFrame: Up to 90 days
measure: Acceptability of the risk stratification system time to complete thoracic oncology clinical team
timeFrame: Up to 90 days
measure: Implementation of PRO-based symptom monitoring
timeFrame: Up to 90 days
measure: Implementation of PRO-based symptom monitoring reported to clinical team
timeFrame: Up to 90 days
measure: Acceptability of PRO-based symptom monitoring subject
timeFrame: Up to 90 days
measure: Acceptability of PRO-based symptom monitoring to the clinical team
timeFrame: Up to 90 days
measure: Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger
state: North Carolina
Study officials:
affiliation: Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
name: Emily Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: