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OpenTrials
Completed

NCT Number: NCT04007458

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MaineGeneral Medical Center

Augusta, Maine, 04330, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letter

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Anne Conners

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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