Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer

Development of an Enhanced Risk Stratification System for Patients With Hospital-diagnosed Advanced Lung Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

subject with hospital-diagnosed advanced lung cancer and must meet all of the eligibility criteria.

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the risk-based stratification system implementation - contacted	The success of the risk-based stratification system implementation- contacted will be determined by the ratio of subjects who were contacted to the whole group is equal to or higher than 70%, in the high-risk group.	Up to 5 days
Success of the risk-based stratification system implementation - referred	The success of the risk-based stratification system implementation- referred will be determined by the ratio of subjects who were referred to the whole group is equal to or higher than 70%, in the high-risk group.	Up to 5 days
Success of the risk-based stratification system implementation - navigation	The success of the risk-based stratification system implementation- navigation will be determined by the ratio of subjects who received guidance to the whole group is equal to or higher than 70%, in the high-risk group.	Up to 16 days
Success of the risk-based stratification system implementation - palliative care	The success of the risk-based stratification system implementation - palliative care will be determined by the ratio of subjects who received palliative care to the whole group is equal to or higher than 70%, in the high-risk group.	Up to 16 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to receipt of outpatient palliative care	The time to receipt of outpatient palliative care will be defined as the time between the date of palliative care and hospital discharge based on the high-risk and low-risk groups.	Up to 90 days
Acceptability of the supportive care intervention	Acceptability of the supportive care intervention will be assessed by the percentage of subjects who attend supportive care consultations as determined through electronic health records ( EHR) review.	Up to 180 days
Acceptability of the risk stratification system the time to complete for providers	Acceptability of the risk stratification system time to complete for providers will be assessed by the time to complete risk stratification per subject.	Up to 90 days
Acceptability of the risk stratification system time to complete thoracic oncology clinical team	Acceptability of the risk stratification system time to complete the thoracic oncology clinical team will be assessed by the perceived usefulness to the thoracic oncology clinical team	Up to 90 days
Implementation of PRO-based symptom monitoring	Implementation of patient reported outcomes (PRO)-based symptom monitoring will be determined by the percentage of eligible subjects who complete weekly PROs and the percentage of concerning symptoms reported to the clinical team of more than 70.	Up to 90 days
Implementation of PRO-based symptom monitoring reported to clinical team	Implementation of PRO-based symptom monitoring will be determined by the percentage of concerning symptoms reported to the clinical team.	Up to 90 days
Acceptability of PRO-based symptom monitoring subject	Acceptability of PRO-based symptom monitoring to subjects will be measured by the percentage of eligible subjects who agree to participate in the patient-reported outcome report (PRO) system (success: >66%).	Up to 90 days
Acceptability of PRO-based symptom monitoring to the clinical team	Acceptability of PRO-based symptom monitoring to the clinical team will be determined by the percentage of concerning symptoms resulting in action by any member of the clinical team.(success: >75% reporting somewhat useful, useful, or very useful).	Up to 90 days
Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team	Acceptability of PRO-based symptom monitoring to the clinical team will be determined by the percentage of concerning symptoms perceived usefulness to the thoracic oncology clinical team (success: >75% reporting somewhat useful, useful, or very useful).	Up to 90 days

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Emily Ray, MD, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): January 5, 2025
• Study Completion (Estimated): May 2, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Cancer; patient reported outcome; High-Risk
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LCCC2205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No