Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients

NCT03929926 | Completed

• 2 other identifiers: 18G.752JT 13384
• Study Type: interventional
• Target: 2,355
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well proactive outreach and shared decision making works in improving lung cancer screening rates in primary care patients. Proactive outreach and shared decision making strategies may help to improve the detection of lung cancer at an earlier stage through screening.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to screening with low dose computed tomography (LDCT)

  Will be assessed through a review of electronic health records data at the end of the study. The main analysis will compare the combined intervention group and the usual care group (Outreach Contact \[OC\]/OC-Decision Counseling Program \[DCP\] versus \[vs.\] usual care \[UC\]) with the Kaplan-Meier method and the log-rank test (stratified by practice). Further analyses will rely on Cox proportional hazards regression to explore the difference between OC and OC-DCP groups, as well as differences across practices and patient characteristics (age, gender, race, current vs. former smoking, etc.).

  From the date of randomization to the date of screening (for those screened) or to the date of the review (for those not screened, "censored", assessed at 3 months

Study Arms (3)

Group 1 (usual care)

ACTIVE COMPARATOR

receive usual care

Other: Best Practice

Group II (outreach contact)

EXPERIMENTAL

Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Eligible and interested patients receive an office visit at the JLCSP for shared decision-making and possible lung cancer screening.

Behavioral: Cancer Educational Materials; Other: Behavioral, Psychological or Informational Intervention

Group III (outreach + Decision Counseling Program)

EXPERIMENTAL

Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.

Behavioral: Cancer Educational Materials; Other: Behavioral, Psychological or Informational Intervention; Other: Counseling

Interventions

Best Practice OTHER

receive usual care

Also known as: standard of care, standard therapy

Group 1 (usual care)

Cancer Educational Materials BEHAVIORAL

Receive educational materials via mail

Group II (outreach contact); Group III (outreach + Decision Counseling Program)

Behavioral, Psychological or Informational Intervention OTHER

Receive shared decision making and lung cancer screening information

Group II (outreach contact); Group III (outreach + Decision Counseling Program)

Counseling OTHER

Undergo decision counseling session

Also known as: Counseling intervention

Group III (outreach + Decision Counseling Program)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had a recent office visit with a primary care physician in one of the study practices.
• History of smoking (current or former) in the electronic health record (EHR).

You may not qualify if:

• LDCT performed in the 12 months prior to study initiation according to EHR.
• Diagnosis of lung cancer indicated in problem list in the EHR.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ronald Myers

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: June 19, 2019
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)