Lung CancerNCT05722847
Risk Stratification for Patients With Hospital-diagnosed Advanced Lung Cancer
An observational study of Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 2 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study has 2 different populations: Patient participants and Health Care Providers. Subjects with hospital-diagnosed advanced lung cancer must meet all of the eligibility criteria, and Health Care Workers provide care to these subjects.
Who may be able to join
- 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
- 1. Able to complete a web-based or telephonic symptom survey.
- 1. Thoracic medical oncology physicians, advance practice providers, and nurse navigators work in the study site and respond to the survey that assesses acceptability.
Who cannot join
- 1. 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- Advanced Cancer, High-Risk, patient reported outcome
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Health Care Providers Group | Thoracic medical oncology physicians, advance practice providers, and nurse navigators respond to the survey that assess acceptability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 16 days
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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%).
Measured: 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).
Measured: 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).
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start14 Mar 2023
- Primary completion5 Jan 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Ray, MD, Principal investigator, Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722847
- Sponsor's protocol ID
- LCCC2205
- Status last verified
- May 2025
- First submitted
- 26 Jan 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Enhanced Risk Stratification System for Patients With Hospital-diagnosed Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT05722847
- Acronym / sponsor ID
- LCCC2205
- Conditions
- Lung Cancer
- Keywords
- Advanced Cancer, High-Risk, patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Health Care Providers Group | – | –Thoracic medical oncology physicians, advance practice providers, and nurse navigators respond to the survey that assess acceptability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study has 2 different populations: Patient participants and Health Care Providers. Subjects with hospital-diagnosed advanced lung cancer must meet all of the eligibility criteria, and Health Care Workers provide care to these subjects.
Key inclusion criteria (5 listed)
- 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
- 1. Able to complete a web-based or telephonic symptom survey.
- 1. Thoracic medical oncology physicians, advance practice providers, and nurse navigators work in the study site and respond to the survey that assesses acceptability.
Key exclusion criteria (5 listed)
- 1. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 - 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 - 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 - 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.
9 secondary outcomes
Time to receipt of outpatient palliative care
Time frame: Up to 90 days
Acceptability of the supportive care intervention
Time frame: Up to 180 days
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 thoracic oncology clinical team
Time frame: Up to 90 days
Implementation of PRO-based symptom monitoring
Time frame: Up to 90 days
Implementation of PRO-based symptom monitoring reported to clinical team
Time frame: Up to 90 days
Acceptability of PRO-based symptom monitoring subject
Time frame: Up to 90 days
Acceptability of PRO-based symptom monitoring to the clinical team
Time frame: Up to 90 days
Acceptability of PRO-based symptom monitoring to the thoracic oncology clinical team
Time frame: Up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Ray, MD principal investigator
Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the risk-based stratification system implementation - contacted (time frame: Up to 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.