NCT04308226

Lung Cancer Screening Navigation for Homeless People

Completed NA Results posted Last updated 9 October 2024

What this trial tests

NA trial testing Patient Navigation in Lung Cancer in 261 participants. Completed in 29 March 2023.

Timeline

20 November 2020

Primary endpoint
6 February 2023

29 March 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	261
Start date	20 November 2020
Primary completion	6 February 2023
Estimated completion	29 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Patient Navigation

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Tobacco Use — all drugs for Tobacco Use →
• Homelessness — all drugs for Homelessness →

Sponsor

Massachusetts General Hospital

Who can join

Adults 55 to 77, any sex, with Lung Cancer or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks). Primary · 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.

Group	Value	95% CI
Usual Care Without Patient Navigation	8
Usual Care With Patient Navigation	75

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. Secondary · 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.

Group	Value	95% CI
Usual Care Without Patient Navigation	1
Usual Care With Patient Navigation	2

Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) Secondary · 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)

Group	Value	95% CI
Usual Care Without Patient Navigation	NA	NA – NA
Usual Care With Patient Navigation	9.7	7.3 – 12.1

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clonal Evolution and Heterogeneity of Osimertinib Acquired Resistance Mechanisms in EGFR Mutant Lung Cancer.
   Roper N, Brown AL, Wei JS, Pack S, et al · · 2020 · cited 135× · PMID 32483558 · DOI 10.1016/j.xcrm.2020.100007
2. Patient Navigation for Lung Cancer Screening at a Health Care for the Homeless Program: A Randomized Clinical Trial.
   Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, et al · · 2024 · cited 15× · PMID 38856994 · DOI 10.1001/jamainternmed.2024.1662
3. Homelessness, Patient Navigation, and Lung Cancer Screening in a Health Center Setting: A Subgroup Analysis of a Randomized Clinical Trial.
   Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, et al · · 2025 · PMID 40674053 · DOI 10.1001/jamanetworkopen.2025.19780