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A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

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ClinicalTrials.gov Identifier: NCT04675476
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:
To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Provider Prompt & Patient Outreach and Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Multilevel Intervention Behavioral: Provider Prompt & Patient Outreach and Education
To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.
No Intervention: Nonequivalent Control Group


Outcome Measures
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Primary Outcome Measures :
  1. provider-patient discussion [ Time Frame: 1-week post-visit ]
    Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')

  2. lung cancer screening intentions [ Time Frame: 1-week post-visit ]
    Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')

  3. lung cancer screening knowledge [ Time Frame: 1-week post-visit ]
    15-item lung cancer screening knowledge measure


Secondary Outcome Measures :
  1. lung cancer screening referrals [ Time Frame: 6-months ]
    Total number of lung screening orders captured via the electronic medical record

  2. lung cancer screening completion rates [ Time Frame: 6-months ]
    Total number of lung screening completions captured via the electronic medical record


Eligibility Criteria
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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:

  • 55-80 years old;
  • current cigarette smoker or quit within 15 years;
  • a 30+ pack-year smoking history;
  • non-adherent to lung screening (>13 months);
  • English-speaking;
  • scheduled for an upcoming clinic appointment (2 weeks - 8 weeks); and
  • able and willing to provide meaningful consent and complete telephone interviews

Exclusion Criteria:

  • Individuals with a history of lung cancer
Contacts and Locations
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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): NCT04675476


Contacts
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Contact: Randi M Williams, PhD (202) 687-7036 rmw27@georgetown.edu

Sponsors and Collaborators
Georgetown University
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT04675476    
Other Study ID Numbers: STUDY00003277
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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