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

November 25, 2020 updated by: Anne Conners
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Augusta, Maine, United States, 04330
        • MaineGeneral Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Letter
Patients will receive a letter reminding them that they are overdue for repeat annual screening.
Behavioral: Letter
MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.
Experimental: Community 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.
Behavioral: Community 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completed low dose CT scan
Time Frame: through study completion, an average of 1 year
Percentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scheduled low dose CT scan
Time Frame: through study completion, an average of one year
Percentage of patients who schedule a low dose CT scan within 3 months of the date on which they were initially contacted by letter
through study completion, an average of one year
Tobacco counseling
Time Frame: through study completion, an average of one year
Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment
through study completion, an average of one year
Maine Tobacco Helpline Referral
Time Frame: trhough study compeltion, an average of one year
Percentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline
trhough study compeltion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne Conners

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1419555

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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