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NCT04308226 · ClinicalTrials.gov registry record · NA
Lung Cancer Screening Navigation for Homeless People
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 261
- Enrollment target
NCT04308226: Completed NA study, sponsored by Massachusetts General Hospital.
NCT04308226 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 261 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308226, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 261 participants
- Enrollment target
Study Summary
The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and the investigators hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS. The investigators will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers. The primary aim of the trial is to determine-among homeless-experienced people who are eligible for LCS-the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records. Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities f
Interventions
- BEHAVIORAL Patient Navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2023-03-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04308226
The ClinicalTrials.gov registry entry for NCT04308226 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 261 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Patient Navigation is the first listed.
NCT04308226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04308226 about?
NCT04308226 is a clinical study titled "Lung Cancer Screening Navigation for Homeless People". The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is...
What is the current status of trial NCT04308226?
This trial is currently completed. It is a NA study. The enrollment target is 261 participants. The study started on 2020-11-20. Estimated completion is 2023-03-29.
What interventions are being tested in trial NCT04308226?
The interventions under investigation include: Patient Navigation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04308226?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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