Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer

NCT ID: NCT05722847

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2025-05-02

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low risk

Subjects will be considered low risk if they have non-small cell histology, a length of hospital stay \<= 8 days, no or low comorbidity, no emergency department use or hospitalization in the 6 months prior, no wheelchair requirement when hospital discharge, or other than Black and/or Hispanic race.

No interventions assigned to this group

High risk

Subjects will be considered high risk if they have small cell histology, a length of hospital stay \> 8 days, high comorbidity, emergency department use or hospitalization in the 6 months prior, prescription of a wheelchair when hospital discharge, or Black and/or Hispanic race.

No interventions assigned to this group

Health Care Providers Group

Thoracic medical oncology physicians, advance practice providers, and nurse navigators respond to the survey that assess acceptability.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

1. Thoracic medical oncology physicians, advance practice providers, and nurse navigators work in the study site and respond to the survey that assesses acceptability.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Locations

UNC Lineberger

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC2205

Identifier Type: -

Identifier Source: org_study_id