MedPath

Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer

Active, not recruiting
Conditions
Lung Cancer
Registration Number
NCT05722847
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Success of the risk-based stratification system implementation - navigationUp to 16 days

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.

Success of the risk-based stratification system implementation - referredUp to 5 days

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.

Success of the risk-based stratification system implementation - contactedUp to 5 days

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.

Success of the risk-based stratification system implementation - palliative careUp to 16 days

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.

Secondary Outcome Measures
NameTimeMethod
Acceptability of the supportive care interventionUp to 180 days

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.

Acceptability of the risk stratification system time to complete thoracic oncology clinical teamUp to 90 days

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

Time to receipt of outpatient palliative careUp to 90 days

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.

Acceptability of the risk stratification system the time to complete for providersUp to 90 days

Acceptability of the risk stratification system time to complete for providers will be assessed by the time to complete risk stratification per subject.

Implementation of PRO-based symptom monitoring reported to clinical teamUp to 90 days

Implementation of PRO-based symptom monitoring will be determined by the percentage of concerning symptoms reported to the clinical team.

Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical teamUp to 90 days

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).

Acceptability of PRO-based symptom monitoring to the clinical teamUp to 90 days

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).

Implementation of PRO-based symptom monitoringUp to 90 days

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.

Acceptability of PRO-based symptom monitoring subjectUp to 90 days

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%).

Trial Locations

Locations (1)

UNC Lineberger

🇺🇸

Chapel Hill, North Carolina, United States

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