Testing Informed Decision Making in Lung Cancer Screening

NCT04940221 | Completed Results

• 2 other identifiers: 603913U54GM104941
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Received a Low Dose CT Scan of the Chest

  Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance.

  1 year

Study Arms (1)

Phone-delivered decision-counseling program for shared decision making in lung cancer screening

EXPERIMENTAL

All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group.

Behavioral: Shared Decision Making

Interventions

Shared Decision Making BEHAVIORAL

Telephone delivered non-persuasive shared decision-making for lung cancer screening.

Phone-delivered decision-counseling program for shared decision making in lung cancer screening

Eligibility Criteria

• Age: 55 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or former smoker
• Greater than or equal to 30 pack years smoking

You may not qualify if:

• Prior CT in last year
• Quit smoking greater than 15 years ago
• Current diagnosis of lung cancer

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Thomas Jefferson University: collaborator
• University of Delaware: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Heather Bittner Fagan, MD MPH
• Organization: Christiana Care Health System

hbittner-fagan@christianacare.org

302 320 4110

Study Officials

• Heather B Fagan, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician - Family Medicine

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 25, 2021
• Study Start: July 18, 2018
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 18, 2023
• Results First Posted: October 20, 2022

Record last verified: 2023-09

Locations

US (1)