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Lung Cancer Screening Navigation for Homeless People

Primary Purpose

Lung Cancer, Tobacco Use, Homelessness

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring lung cancer screening, tobacco use, homeless persons, smoking, low-dose computed tomography

Eligibility Criteria

55 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Boston Health Care for the Homeless Program

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care without patient navigation

Usual care with patient navigation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.
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.

Full Information

First Posted
March 11, 2020
Last Updated
August 11, 2022
Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04308226
Brief Title
Lung Cancer Screening Navigation for Homeless People
Official Title
Lung Cancer Screening Navigation for Homeless People: A Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Tobacco Use, Homelessness
Keywords
lung cancer screening, tobacco use, homeless persons, smoking, low-dose computed tomography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care without patient navigation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Usual care with patient navigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number (percentage) of participants who receive low-dose computed tomography (LDCT) for lung cancer screening (LCS) at 6 months (26 weeks).
Description
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.
Time Frame
6 months (26 weeks)
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months (26 weeks) plus guideline-recommended follow-up timeframe plus 1 month (4 weeks)
Other Pre-specified Outcome Measures:
Title
Time to completion of low-dose computed tomography (LDCT) for lung cancer screening (LCS)
Description
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)
Time Frame
6 months (26 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis P Baggett, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Health Care for the Homeless Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lung Cancer Screening Navigation for Homeless People

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