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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05722847
Enrollment
18
Registered
2023-02-10
Start date
2023-03-14
Completion date
2025-05-02
Last updated
2025-05-25

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

Conditions

Lung Cancer

Keywords

Advanced Cancer, High-Risk, patient reported outcome

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.

Interventions

None listed

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Success of the risk-based stratification system implementation - contactedUp to 5 daysThe 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.
Success of the risk-based stratification system implementation - referredUp to 5 daysThe 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.
Success of the risk-based stratification system implementation - navigationUp to 16 daysThe 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.
Success of the risk-based stratification system implementation - palliative careUp to 16 daysThe 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.

Secondary

MeasureTime frameDescription
Implementation of PRO-based symptom monitoringUp to 90 daysImplementation 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.
Implementation of PRO-based symptom monitoring reported to clinical teamUp to 90 daysImplementation of PRO-based symptom monitoring will be determined by the percentage of concerning symptoms reported to the clinical team.
Time to receipt of outpatient palliative careUp to 90 daysThe 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.
Acceptability of PRO-based symptom monitoring to the clinical teamUp to 90 daysAcceptability 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).
Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical teamUp to 90 daysAcceptability 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).
Acceptability of PRO-based symptom monitoring subjectUp to 90 daysAcceptability 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%).
Acceptability of the supportive care interventionUp to 180 daysAcceptability 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.
Acceptability of the risk stratification system the time to complete for providersUp to 90 daysAcceptability of the risk stratification system time to complete for providers will be assessed by the time to complete risk stratification per subject.
Acceptability of the risk stratification system time to complete thoracic oncology clinical teamUp to 90 daysAcceptability 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026