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Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder

Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04007458
Enrollment
396
Registered
2019-07-05
Start date
2019-07-16
Completion date
2019-12-16
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Screening

Brief summary

This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.

Detailed description

This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.

Interventions

BEHAVIORALLetter

MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.

BEHAVIORALCommunity Health Worker Phone Call

Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.

Sponsors

Anne Conners
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor will be blind to which intervention the subjects have received.

Intervention model description

Eligible patients will be randomly assigned to one of the following two groups: 1\. Control Group: o Annual reminder letter only 1. Intervention Group: 2. Annual reminder letter and Community Health Worker proactive outreach

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 30 or more pack years of tobacco use * If no longer using tobacco, no more than 15 years since last use * At least 13 months since last low dose CT scan screening

Exclusion criteria

* Development of serious medical condition that would preclude treatment of lung cancer if found * Death since baseline screen

Design outcomes

Primary

MeasureTime frameDescription
Completed low dose CT scanthrough study completion, an average of 1 yearPercentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter

Secondary

MeasureTime frameDescription
Scheduled low dose CT scanthrough study completion, an average of one yearPercentage of patients who schedule a low dose CT scan within 3 months of the date on which they were initially contacted by letter
Tobacco counselingthrough study completion, an average of one yearPercentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment
Maine Tobacco Helpline Referraltrhough study compeltion, an average of one yearPercentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026