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

NCT ID: NCT03929926

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2024-05-01

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the combined intervention group (Outreach Contact Group [OC]/Outreach Contact and Decision Counseling Group [OC-DCP]) versus the control usual care group (UC) with respect to time to screening with low dose computed tomography (LDCT).

SECONDARY OBJECTIVES:

I. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the fraction of patients who are referred/scheduled for screening.

II. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the proportion of the referred/scheduled patients who actually keep their screening appointment.

III. To determine cost of implementing the OC and OC-DCP interventions.

EXPLORATORY OBJECTIVES:

I. To compare the two intervention groups (OC-DCP versus [vs.] OC) on the primary and secondary study endpoints (time to LDCT screening, proportion of patients referred/scheduled for screening, proportion of patients keeping their screening appointments, and cost).

II. To assess the feasibility of patient eligibility review by providers in the OC and OC-DCP arms.

III. To assess the difference in success in identifying eligible patients between arms.

IV. To assess the difference in reaching referred patients between arms.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I (USUAL CARE): Patients receive usual care.

GROUP II (OUTREACH CONTACT): 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 Jefferson Lung Cancer Screening Program (JLCSP) for shared decision-making and possible lung cancer screening.

GROUP III (OUTREACH + DECISION COUNSELING PROGRAM): 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.

After completion of study, patients are followed up for 90 days.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Group 1 (usual care)

receive usual care

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

receive usual care

Group II (outreach contact)

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.

Group Type: EXPERIMENTAL

Cancer Educational Materials

Intervention Type: BEHAVIORAL

Receive educational materials via mail

Behavioral, Psychological or Informational Intervention

Intervention Type: OTHER

Receive shared decision making and lung cancer screening information

Group III (outreach + Decision Counseling Program)

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.

Group Type: EXPERIMENTAL

Cancer Educational Materials

Intervention Type: BEHAVIORAL

Receive educational materials via mail

Behavioral, Psychological or Informational Intervention

Intervention Type: OTHER

Receive shared decision making and lung cancer screening information

Counseling

Intervention Type: OTHER

Undergo decision counseling session

Interventions

Best Practice

receive usual care

Intervention Type: OTHER

Cancer Educational Materials

Receive educational materials via mail

Intervention Type: BEHAVIORAL

Behavioral, Psychological or Informational Intervention

Receive shared decision making and lung cancer screening information

Intervention Type: OTHER

Counseling

Undergo decision counseling session

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Counseling intervention

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Myers

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 13384

Identifier Type: OTHER

Identifier Source: secondary_id

18G.752

Identifier Type: -

Identifier Source: org_study_id