Lung Cancer Screening Navigation for Homeless People

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04308226

Collaborator

American Cancer Society, Inc. (Other)

300

Enrollment

Location

Arms

25.4

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Tobacco Use Homelessness	Behavioral: Patient Navigation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

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.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

Official Title:

Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number (percentage) of participants who receive low-dose computed tomography (LDCT) for lung cancer screening (LCS) at 6 months (26 weeks). [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.

Secondary Outcome Measures

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)]
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.

Other Outcome Measures

Time to completion of low-dose computed tomography (LDCT) for lung cancer screening (LCS) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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