Lung Cancer Screening Navigation for Homeless People

Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Lung Cancer; Homelessness
• Intervention / Treatment: Behavioral: Patient Navigation

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Health Care for the Homeless Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months (26 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months (26 weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Travis P Baggett, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): June 27, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: smoking; lung cancer screening; tobacco use; low-dose computed tomography; homeless persons
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2018P001344; RSG-17-157-01-CPPB (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No