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Completed

NCT Number: NCT05722847

Risk Stratification 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Lineberger

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patient Participants:

  • Age ≥ 18 years at the time of screening.
  • Hospital-diagnosed Advanced lung cancer with histological confirmation of disease or suspected lung cancer in the opinion of the treating oncologist.

For PROs only

  • Able to complete a web-based or telephonic symptom survey.

Exclusion criteria

for Patient Participants:

  • Enrollment in hospice upon discharge from the index hospitalization For PROs only
  • Inability to read or speak English.
  • 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.
  • Current incarceration.
  • Any condition that would prohibit the patient from completing PROs

Inclusion criteria

for Health Care Provider Participants:

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Time to receipt of outpatient palliative care

    Time frame: Up 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.

  2. Acceptability of the supportive care intervention

    Time frame: Up 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.

  3. Acceptability of the risk stratification system the time to complete for providers

    Time frame: Up 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.

  4. Acceptability of the risk stratification system time to complete thoracic oncology clinical team

    Time frame: Up 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

  5. Implementation of PRO-based symptom monitoring

    Time frame: Up 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.

  6. Implementation of PRO-based symptom monitoring reported to clinical team

    Time frame: Up to 90 days

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

  7. Acceptability of PRO-based symptom monitoring subject

    Time frame: Up 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%).

  8. Acceptability of PRO-based symptom monitoring to the clinical team

    Time frame: Up 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).

  9. Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team

    Time frame: Up 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).

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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