Trial Outcomes & Findings for Lung Cancer Screening Navigation for Homeless People (NCT NCT04308226)
NCT ID: NCT04308226
Last Updated: 2024-10-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
261 participants
Primary outcome timeframe
6 months (26 weeks)
Results posted on
2024-10-09
Participant Flow
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.
In total, 261 participants enrolled but one participant chose to withdraw before completing the baseline survey and therefore could not be randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
173
|
|
Overall Study
COMPLETED
|
87
|
173
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lung Cancer Screening Navigation for Homeless People
Baseline characteristics by cohort
| Measure |
Usual Care Without Patient Navigation
n=87 Participants
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
n=173 Participants
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.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
61 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
24 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
30 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
29 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Housing status
Currently homeless
|
28 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Housing status
Formerly homeless
|
59 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Health insurance
With health insurance
|
86 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Health insurance
Without health insurance
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary care location
BHCHP program headquarters
|
63 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Primary care location
BHCHP satellite site
|
24 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Prior discussion of LCS with PCP
Yes
|
32 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Prior discussion of LCS with PCP
No
|
55 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
General self-efficacy score
|
32.4 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
32.6 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
32.5 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Health status
Fair/poor
|
46 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Health status
Excellent/very good/good
|
41 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Mental health problem
Yes
|
24 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Mental health problem
No
|
62 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Mental health problem
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Alcohol use problem
Yes
|
16 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Alcohol use problem
No
|
68 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Alcohol use problem
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Drug use problem
Yes
|
21 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Drug use problem
No
|
65 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Drug use problem
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smoking status
Current smoker
|
75 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Pack-years of smoking
|
50.1 pack-years
STANDARD_DEVIATION 21.5 • n=5 Participants
|
47.1 pack-years
STANDARD_DEVIATION 18.3 • n=7 Participants
|
48.1 pack-years
STANDARD_DEVIATION 19.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Usual Care Without Patient Navigation
n=87 Participants
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
n=173 Participants
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.
|
|---|---|---|
|
Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks).
|
8 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Usual Care Without Patient Navigation
n=1 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
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
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months (26 weeks)Population: Outcome summarized by 25th percentile achieving completion.
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 measures
| Measure |
Usual Care Without Patient Navigation
n=87 Participants
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
n=173 Participants
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.
|
|---|---|---|
|
Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS)
|
NA weeks
"Median" is used here to indicate 25th percentile. Not enough participants in this arm achieved the outcome to calculate the 25th percentile and 95% confidence interval.
|
9.7 weeks
Interval 7.3 to 12.1
|
Adverse Events
Usual Care Without Patient Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care With Patient Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Travis Baggett, MD, MPH
Division of General Internal Medicine, Massachusetts General Hospital
Phone: 617-643-9314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place