Homelessness, Lung Cancer, Tobacco Use
Conditions
Keywords
lung cancer screening, tobacco use, homeless persons, smoking, low-dose computed tomography
Brief 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 for improving the navigation intervention for future use.
Interventions
BEHAVIORALPatient 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.
Sponsors
American Cancer Society, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) | 6 months (26 weeks) | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
In total, 261 participants enrolled but one participant chose to withdraw before completing the baseline survey and therefore could not be randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 87 |
| 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. | 173 |
| Total | 260 |
Baseline characteristics
| Characteristic | Usual Care With Patient Navigation | Total | Usual Care Without Patient Navigation |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 4.4 | 60.5 years STANDARD_DEVIATION 4.7 | 60.7 years STANDARD_DEVIATION 5.4 |
| Alcohol use problem No | 126 Participants | 194 Participants | 68 Participants |
| Alcohol use problem Unknown | 2 Participants | 5 Participants | 3 Participants |
| Alcohol use problem Yes | 45 Participants | 61 Participants | 16 Participants |
| Drug use problem No | 122 Participants | 187 Participants | 65 Participants |
| Drug use problem Unknown | 0 Participants | 1 Participants | 1 Participants |
| Drug use problem Yes | 51 Participants | 72 Participants | 21 Participants |
| General self-efficacy score | 32.6 units on a scale STANDARD_DEVIATION 5.8 | 32.5 units on a scale STANDARD_DEVIATION 5.6 | 32.4 units on a scale STANDARD_DEVIATION 5.2 |
| Health insurance With health insurance | 173 Participants | 259 Participants | 86 Participants |
| Health insurance Without health insurance | 0 Participants | 1 Participants | 1 Participants |
| Health status Excellent/very good/good | 87 Participants | 128 Participants | 41 Participants |
| Health status Fair/poor | 86 Participants | 132 Participants | 46 Participants |
| Housing status Currently homeless | 56 Participants | 84 Participants | 28 Participants |
| Housing status Formerly homeless | 117 Participants | 176 Participants | 59 Participants |
| Mental health problem No | 121 Participants | 183 Participants | 62 Participants |
| Mental health problem Unknown | 1 Participants | 2 Participants | 1 Participants |
| Mental health problem Yes | 51 Participants | 75 Participants | 24 Participants |
| Pack-years of smoking | 47.1 pack-years STANDARD_DEVIATION 18.3 | 48.1 pack-years STANDARD_DEVIATION 19.5 | 50.1 pack-years STANDARD_DEVIATION 21.5 |
| Primary care location BHCHP program headquarters | 121 Participants | 184 Participants | 63 Participants |
| Primary care location BHCHP satellite site | 52 Participants | 76 Participants | 24 Participants |
| Prior discussion of LCS with PCP No | 106 Participants | 161 Participants | 55 Participants |
| Prior discussion of LCS with PCP Yes | 67 Participants | 99 Participants | 32 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 24 Participants | 38 Participants | 14 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 66 Participants | 96 Participants | 30 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 14 Participants | 26 Participants | 12 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 67 Participants | 96 Participants | 29 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 4 Participants | 2 Participants |
| Sex/Gender, Customized Female | 50 Participants | 74 Participants | 24 Participants |
| Sex/Gender, Customized Male | 123 Participants | 184 Participants | 61 Participants |
| Sex/Gender, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Smoking status Current smoker | 146 Participants | 221 Participants | 75 Participants |
| Smoking status Former smoker | 27 Participants | 39 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 87 | 1 / 173 |
| other Total, other adverse events | 0 / 87 | 0 / 173 |
| serious Total, serious adverse events | 0 / 87 | 0 / 173 |
Outcome results
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.
Time frame: 6 months (26 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Without Patient Navigation | Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks). | 8 Participants |
| Usual Care With Patient Navigation | Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks). | 75 Participants |
p-value: <0.001Chi-squared
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.
Time frame: 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Without Patient Navigation | 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. | 1 Participants |
| Usual Care With Patient Navigation | 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. | 2 Participants |
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)
Time frame: 6 months (26 weeks)
Population: Outcome summarized by 25th percentile achieving completion.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care Without Patient Navigation | Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) | NA weeks |
| Usual Care With Patient Navigation | Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) | 9.7 weeks |
p-value: <0.001Log Rank