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

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ClinicalTrials.gov Identifier: NCT03929926
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Best Practice Behavioral: Cancer Educational Materials Other: Behavioral, Psychological or Informational Intervention Other: Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Group 1 (usual care)
receive usual care
Other: Best Practice
receive usual care
Other Names:
  • standard of care
  • standard therapy

Experimental: 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.
Behavioral: Cancer Educational Materials
Receive educational materials via mail

Other: Behavioral, Psychological or Informational Intervention
Receive shared decision making and lung cancer screening information

Experimental: 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.
Behavioral: Cancer Educational Materials
Receive educational materials via mail

Other: Behavioral, Psychological or Informational Intervention
Receive shared decision making and lung cancer screening information

Other: Counseling
Undergo decision counseling session
Other Name: Counseling intervention




Primary Outcome Measures :
  1. Time to screening with low dose computed tomography (LDCT) [ Time Frame: 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 ]
    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.).



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929926


Contacts
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Contact: Ronald Myers 215-503-4085 Ronald.Myers@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Ronald Myers         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Ronald Myers Sidney Kimmel Cancer Center at Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03929926     History of Changes
Other Study ID Numbers: 18G.752
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases