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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007458
• Other study ID #: 1419555
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: November 2020
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	MaineGeneral Medical Center	Augusta	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Anne Conners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completed low dose CT scan	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	Scheduled low dose CT scan	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
Secondary	Tobacco counseling	Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment	through study completion, an average of one year
Secondary	Maine Tobacco Helpline Referral	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