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Clinical Trials/NCT05722847
NCT05722847
Completed
Not Applicable

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

UNC Lineberger Comprehensive Cancer Center1 site in 1 country18 target enrollmentMarch 14, 2023
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
18
Locations
1
Primary Endpoint
Success of the risk-based stratification system implementation - navigation
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 14, 2023
End Date
May 2, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Success of the risk-based stratification system implementation - navigation

Time Frame: Up 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 - referred

Time Frame: Up 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 - contacted

Time Frame: Up 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 care

Time Frame: Up 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 Outcomes

  • Acceptability of the supportive care intervention(Up to 180 days)
  • Acceptability of the risk stratification system time to complete thoracic oncology clinical team(Up to 90 days)
  • Time to receipt of outpatient palliative care(Up to 90 days)
  • Acceptability of the risk stratification system the time to complete for providers(Up to 90 days)
  • Implementation of PRO-based symptom monitoring reported to clinical team(Up to 90 days)
  • Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team(Up to 90 days)
  • Acceptability of PRO-based symptom monitoring to the clinical team(Up to 90 days)
  • Implementation of PRO-based symptom monitoring(Up to 90 days)
  • Acceptability of PRO-based symptom monitoring subject(Up to 90 days)

Study Sites (1)

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