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

NCT ID: NCT04007458

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2019-12-16

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

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

Study Groups

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Letter

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

Group Type ACTIVE_COMPARATOR

Letter

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Community Health Worker Phone Call

Intervention Type BEHAVIORAL

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.

Interventions

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Letter

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anne Conners

OTHER

Sponsor Role lead

Responsible Party

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Anne Conners

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MaineGeneral Medical Center

Augusta, Maine, United States

Site Status

Countries

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United States

Other Identifiers

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1419555

Identifier Type: -

Identifier Source: org_study_id