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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Letter

Community Health Worker Phone Call

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Screening

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MaineGeneral Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Letter

Community Health Worker phone call

Arm Description

Patients will receive a letter reminding them that they are overdue for repeat annual screening.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Tobacco counseling

Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment

Maine Tobacco Helpline Referral

Percentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline

Full Information

NCT ID

NCT04007458

First Posted

July 1, 2019

Last Updated

November 25, 2020

Sponsor

Anne Conners

1. Study Identification

Unique Protocol Identification Number

NCT04007458

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 16, 2019 (Actual)

Primary Completion Date

December 16, 2019 (Actual)

Study Completion Date

December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anne Conners

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Screening

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Letter

Arm Type

Active Comparator

Arm Description

Patients will receive a letter reminding them that they are overdue for repeat annual screening.

Arm Title

Community Health Worker phone call

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Letter

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Community Health Worker Phone Call

Intervention Description

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.

Primary Outcome Measure Information:

Title

Completed low dose CT scan

Description

Percentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Scheduled low dose CT scan

Description

Percentage of patients who schedule a low dose CT scan within 3 months of the date on which they were initially contacted by letter

Time Frame

through study completion, an average of one year

Title

Tobacco counseling

Description

Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment

Time Frame

through study completion, an average of one year

Title

Maine Tobacco Helpline Referral

Description

Percentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline

Time Frame

trhough study compeltion, an average of one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

MaineGeneral Medical Center

City

Augusta

State/Province

Maine

ZIP/Postal Code

04330

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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