Lung CancerNCT04308226
Lung Cancer Screening Navigation for Homeless People
A study testing Patient Navigation in people with Lung Cancer and Tobacco Use, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 77 years
- Conditions the study is for
- Lung Cancer, Tobacco Use, Homelessness
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently or formerly homeless
- Have a 30 pack-year smoking history and have smoked within the past 15 years
- Have a Boston Health Care for the Homeless (BHCHP) primary care provider (PCP)
- Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers
Who cannot join
- Prior chest computed tomography (CT) imaging in the past 12 months
- Personal history of lung cancer, or current presentation with symptoms concerning for lung cancer (e.g. hemoptysis or unexplained weight loss of >15 lbs. in the past year)
- PCP is the principal investigator
- Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Health Care for the Homeless Program
Boston, Massachusetts, 02118
About this study
Official title: Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial
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.
Read more
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 for improving the navigation intervention for future use.
- Conditions
- Lung Cancer, Tobacco Use, Homelessness
- Being tested
- Patient Navigation
- Keywords
- lung cancer screening, tobacco use, homeless persons, smoking, low-dose computed tomography
- Medical subject headings
- Lung Neoplasms, Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
The navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing Boston Health Care for the Homeless (BHCHP) clinical structure and collaborate with participants' primary care providers (PCPs) to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke.
| Study group | Role | What they receive |
|---|---|---|
| Usual care without patient navigation | No intervention | Participants assigned to this arm will be given basic educational materials on general lung health and referred back to their primary care provider (PCP) for management as per usual practice. |
| Usual care with patient navigation | Experimental | Participants assigned to this arm will be informed about lung cancer screening (LCS), provided educational materials on LCS and patient navigation, and offered access to an LCS navigator who will partner with participants and primary care providers (PCPs) to facilitate low-dose computed tomography (LDCT) completion and follow-up. Receives: Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks).
This outcome will be based on radiology records verifying that a chest computed tomography (CT) was performed for LCS and interpreted according to the lung imaging reporting and data system (Lung-RADS) framework.
Measured: 6 months (26 weeks)
Secondary outcomes (1)
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks) With Diagnostic Follow-up of Abnormal Results Within 1 Month (4 Weeks) of the Recommended Time Frame.
Participants must achieve the primary outcome and, if the result is abnormal (lung imaging reporting and data system lung imaging reporting and data system (Lung-RADS) category 3 or 4), also obtain the next recommended follow-up test within 1 month (4 weeks) of the advised timeframe based on the Lung-RADS framework. Radiology records will be obtained for participants who underwent LDCT for LCS to document the findings of the study, determine the Lung-RADS category associated with those findings, and ascertain the recommended diagnostic follow-up plan.
Measured: 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start20 Nov 2020
- Primary completion6 Feb 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 2:1 ratio to usual care with (N=200) or without (N=100) lung cancer screening (LCS) navigation. Randomization will be stratified by smoking status, housing status, clinical site, and whether participants have already discussed LCS with their primary care provider (PCP) to ensure balance between study arms on these variables.
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Travis Paul Baggett, Massachusetts General Hospital
- Investigators
- Travis P Baggett, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308226
- Sponsor's protocol ID
- 2018P001344
- Other IDs
- RSG-17-157-01-CPPB
- Status last verified
- Oct 2024
- First submitted
- 11 Mar 2020
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Little BR, Chang Y, Park ER, Rigotti NA, Fine DR. Homelessness, Patient Navigation, and Lung Cancer Screening in a Health Center Setting: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519780. doi: 10.1001/jamanetworkopen.2025.19780.
PubMed 40674053Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Critchley N, Kennedy E, Hart K, Joyce A, Chang Y, Percac-Lima S, Park ER, Rigotti NA. Patient Navigation for Lung Cancer Screening at a Health Care for the Homeless Program: A Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):892-902. doi: 10.1001/jamainternmed.2024.1662.
PubMed 38856994
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04308226
- Acronym / sponsor ID
- 2018P001344
- Conditions
- Lung Cancer, Tobacco Use, Homelessness
- Keywords
- lung cancer screening, tobacco use, homeless persons, smoking, low-dose computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 for improving the navigation intervention for future use.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 ratio to usual care with (N=200) or without (N=100) lung cancer screening (LCS) navigation. Randomization will be stratified by smoking status, housing status, clinical site, and whether participants have already discussed LCS with their primary care provider (PCP) to ensure balance between study arms on these variables.
| Arm | Type | Receives |
|---|---|---|
| Usual care without patient navigation | No intervention | –Participants assigned to this arm will be given basic educational materials on general lung health and referred back to their primary care provider (PCP) for management as per usual practice. |
| Usual care with patient navigation | Experimental | Behavioral: Patient NavigationParticipants assigned to this arm will be informed about lung cancer screening (LCS), provided educational materials on LCS and patient navigation, and offered access to an LCS navigator who will partner with participants and primary care providers (PCPs) to facilitate low-dose computed tomography (LDCT) completion and follow-up. |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently or formerly homeless
- Have a 30 pack-year smoking history and have smoked within the past 15 years
- Have a Boston Health Care for the Homeless (BHCHP) primary care provider (PCP)
- Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers
Key exclusion criteria (4 listed)
- Prior chest computed tomography (CT) imaging in the past 12 months
- Personal history of lung cancer, or current presentation with symptoms concerning for lung cancer (e.g. hemoptysis or unexplained weight loss of >15 lbs. in the past year)
- PCP is the principal investigator
- Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationThe navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing Boston Health Care for the Homeless (BHCHP) clinical structure and collaborate with participants' primary care providers (PCPs) to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke. | Behavioural | Usual care with patient navigation |
Primary outcome
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks).
Time frame: 6 months (26 weeks)
This outcome will be based on radiology records verifying that a chest computed tomography (CT) was performed for LCS and interpreted according to the lung imaging reporting and data system (Lung-RADS) framework.
1 secondary outcome
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks) With Diagnostic Follow-up of Abnormal Results Within 1 Month (4 Weeks) of the Recommended Time Frame.
Time frame: 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40674053Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Little BR, Chang Y, Park ER, Rigotti NA, Fine DR. Homelessness, Patient Navigation, and Lung Cancer Screening in a Health Center Setting: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519780. doi: 10.1001/jamanetworkopen.2025.19780.
- Derived from this study: PubMed 38856994Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Critchley N, Kennedy E, Hart K, Joyce A, Chang Y, Percac-Lima S, Park ER, Rigotti NA. Patient Navigation for Lung Cancer Screening at a Health Care for the Homeless Program: A Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):892-902. doi: 10.1001/jamainternmed.2024.1662.
- 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.
Travis P Baggett, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Lung Cancer and Tobacco Use, run by Massachusetts General Hospital 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 4 inclusion and 4 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 9 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks). (time frame: 6 months (26 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308226, which also lists 2 linked publications.
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 9 Oct 2024.