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| ID | Type | Description | Link |
|---|---|---|---|
| RSG-17-157-01-CPPB | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months (26 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) | Time between date of randomization and date of receipt of low-dose computed tomography (LDCT) for lung cancer screening (LCS) or date of censoring (6 months / 26 weeks) | 6 months (26 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Travis P Baggett, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Health Care for the Homeless Program | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40674053 | Derived | 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. | |
| 38856994 |
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In total, 261 participants enrolled but one participant chose to withdraw before completing the baseline survey and therefore could not be randomized.
Trial recruitment occurred between 2020-2022. The trial was conducted at Boston Health Care for the Homeless Program (BHCHP), a federally-qualified healthcare for the homeless program that serves nearly 10,000 patients each year across more than 30 service sites in greater Boston (www.bhchp.org). Individuals were recruited through a combination of in-person and phone-based outreach as well as referrals from BHCHP primary care providers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Without Patient Navigation | 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. |
| FG001 | Usual Care With Patient Navigation | 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. Patient Navigation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Without Patient Navigation | 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. |
| BG001 | Usual Care With Patient Navigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months (26 weeks) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Without Patient Navigation | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis Baggett, MD, MPH | Division of General Internal Medicine, Massachusetts General Hospital | 617-643-9314 | tbaggett@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2021 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D064424 | Tobacco Use |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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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.
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| 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks) |
| Baggett 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. |
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. Patient Navigation: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 4 participants had unknown race/ethnicity due to item non-response. | Count of Participants | Participants |
|
| Housing status | Operationalization of current homelessness is concordant with the definition in the HEARTH Act of 20091 and used by the US Department of Housing and Urban Development. | Count of Participants | Participants |
|
| Health insurance | Count of Participants | Participants |
|
| Primary care location | Count of Participants | Participants |
|
| Prior discussion of LCS with PCP | Whether participants had ever discussed lung cancer screening with their primary care provider prior to study enrollment (self-reported). | Count of Participants | Participants |
|
| General self-efficacy score | Score range 10-40; higher scores represent greater self-efficacy. | Mean | Standard Deviation | units on a scale |
|
| Health status | Based on a single-item assessment of self-rated health. | Count of Participants | Participants |
|
| Mental health problem | Defined as a score ≥13 on the 6-item Kessler Psychological Distress Scale (K6); 2 participants with status unknown due to item non-response. | Count of Participants | Participants |
|
| Alcohol use problem | Defined as a score ≥3 on the Alcohol Use Disorders Identification Test - Concise (AUDIT-C); 5 participants with status unknown due to item non-response. | Count of Participants | Participants |
|
| Drug use problem | Defined as a score ≥3 on the Drug Abuse Screening Test (DAST-10); 1 participant with status unknown due to item non-response. | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Pack-years of smoking | Calculated by multiplying the number of years of smoking by the typical number of packs per day consumed during those years. | Mean | Standard Deviation | pack-years |
|
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.
Patient Navigation: 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.
|
|
|
| Secondary | 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. | Participants who completed LDCT for LCS with Lung-RADS scores ≥3 meriting earlier than annual follow-up (typically 6 months for Lung-RADS 3, 3 months for Lung-RADS 4A, and immediate for Lung-RADS 4B/X). In the usual care without patient navigation arm, 1 participant received a Lung-RADS score of 4A. In the usual care with patient navigation arm, 6 participants received a Lung-RADS score of 3, 2 participants received a score of 4A, and 1 participant received a score of 4B. | Posted | Count of Participants | Participants | 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks) |
|
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|
| Other Pre-specified | Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) | Time between date of randomization and date of receipt of low-dose computed tomography (LDCT) for lung cancer screening (LCS) or date of censoring (6 months / 26 weeks) | Outcome summarized by 25th percentile achieving completion. | Posted | Median | 95% Confidence Interval | weeks | 6 months (26 weeks) |
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|
| 1 |
| 87 |
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Usual Care With Patient Navigation | 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. Patient Navigation: 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. | 1 | 173 | 0 | 173 | 0 | 173 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D006298 | Health Services Administration |