Clinical trial NCT04308226: Lung Cancer Screening Navigation for Homeless People
Official title: Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Tobacco Use
Homelessness
Keywords: lung cancer screening
tobacco use
homeless persons
smoking
low-dose computed tomography
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-03-13
Enrollment: 261
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number (Percentage) of Participants Who Receive Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS) at 6 Months (26 Weeks).
timeFrame: 6 months (26 weeks)
Secondary outcomes:
measure: 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.
timeFrame: 6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)
Other outcomes:
measure: Time to Completion of Low-dose Computed Tomography (LDCT) for Lung Cancer Screening (LCS)
timeFrame: 6 months (26 weeks)
Locations:
city: Boston
country: United States
facility: Boston Health Care for the Homeless Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Travis P Baggett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: