Lung Cancer Screening Navigation for Homeless People

NCT04308226 | Completed Results

• 2 other identifiers: 2018P001344RSG-17-157-01-CPPB
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Tobacco Use; Homelessness

Keywords

lung cancer screening; tobacco use; homeless persons; smoking; low-dose computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)

Other Outcomes (1)

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

  6 months (26 weeks)

Study Arms (2)

Usual care without patient navigation

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Patient Navigation BEHAVIORAL

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.

Usual care with patient navigation

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Boston Health Care for the Homeless Program

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Little BR, Chang Y, Park ER, Rigotti NA, Fine DR. Homelessness, Patient Navigation, and Lung Cancer Screening in a Health Center Setting: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519780. doi: 10.1001/jamanetworkopen.2025.19780.

  PMID: 40674053 DERIVED

• Baggett TP, Sporn N, Barbosa Teixeira J, Rodriguez EC, Anandakugan N, Critchley N, Kennedy E, Hart K, Joyce A, Chang Y, Percac-Lima S, Park ER, Rigotti NA. Patient Navigation for Lung Cancer Screening at a Health Care for the Homeless Program: A Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):892-902. doi: 10.1001/jamainternmed.2024.1662.

  PMID: 38856994 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use; Smoking

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Travis Baggett, MD, MPH
• Organization: Division of General Internal Medicine, Massachusetts General Hospital

tbaggett@mgh.harvard.edu

617-643-9314

Study Officials

• Travis P Baggett, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: November 20, 2020
• Primary Completion: February 6, 2023
• Study Completion: March 29, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)