Lung Cancer Screening Navigation for Homeless People
Condition: Lung Cancer; Tobacco Use; Homelessness
MeSH terms: Lung Neoplasms
Study type: Interventional

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.
    


Intervention name(s): Patient Navigation
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: lung cancer screening; tobacco use; homeless persons; smoking; low-dose computed tomography