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

NCT04007458 | Completed

• 1 other identifier: 1419555
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Scheduled low dose CT scan

  through study completion, an average of one year

• Tobacco counseling

  through study completion, an average of one year

• Maine Tobacco Helpline Referral

  trhough study compeltion, an average of one year

Study Arms (2)

Letter

ACTIVE COMPARATOR

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

Behavioral: Letter

Community Health Worker phone call

EXPERIMENTAL

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

Interventions

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.

Letter

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.

Community Health Worker phone call

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Development of serious medical condition that would preclude treatment of lung cancer if found
• Death since baseline screen

Sponsors & Collaborators

• Anne Conners: lead

Study Sites (1)

MaineGeneral Medical Center

Augusta, Maine, 04330, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

College Fraternities and Sororities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blind to which intervention the subjects have received.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: July 16, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

US (1)