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Digital Outreach Intervention for Lung Cancer Screening (mPATH-Lung)

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ClinicalTrials.gov Identifier: NCT04083859
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.

This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.


Condition or disease Intervention/treatment Phase
Lung Cancer Other: mPATH-Lung Other: Lung health video Not Applicable

Detailed Description:

Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.

Secondary Objectives:

  • Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 60 patients.
  • Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mPATH-Lung
Participants randomized to the mPATH arm will complete a self-survey and a brief video decision aid, and then invites them to estimate their personal risks and benefits of screening by completing 8 survey items needed to calculate their predicted risk of developing lung cancer based on the validated Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Model 2012.
Other: mPATH-Lung
A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.

Placebo Comparator: Usual care (CONTROL)
Participants randomized to the control arm will see an animated video about exercise for lung health based on recommendations from the European Lung Foundation. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.
Other: Lung health video
Web-based video about guideline recommended exercise for lung health




Primary Outcome Measures :
  1. Completion of a lung cancer screening CT scan [ Time Frame: Within 16 weeks of enrollment ]
    Completed low-dose chest CT for lung cancer screening within 16 weeks of study randomization, as determined by electronic health record review


Secondary Outcome Measures :
  1. Knowledge of LCS among patients who indicate a strong preference for or against screening [ Time Frame: Up to 16 weeks after day of enrollment ]
    Mean number of lung cancer screening knowledge items answered correctly

  2. Knowledge of LCS among all patients [ Time Frame: Up to 16 weeks after day of enrollment ]
    Mean number of lung cancer screening knowledge items answered correctly

  3. Intention to receive LCS [ Time Frame: Up to 16 weeks after day of enrollment ]
    Patient intention to receive LCS as measured by a survey item

  4. Lung cancer screening decision [ Time Frame: Up to 16 weeks after day of enrollment ]
    Patient decision to receive or forego lung cancer screening in the mPATH-Lung group only

  5. Proportion of patients with LCS clinic visits scheduled [ Time Frame: 16 weeks ]
    The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed

  6. Proportion of patients with LCS clinic visits completed [ Time Frame: 16 weeks ]
    The proportion of patients in each arm who have completed a LCS clinic visit

  7. Proportion of patients with LCS scans ordered [ Time Frame: 16 weeks ]
    The proportion of patients in each arm for whom a LCS scan was ordered

  8. Lung cancer screening test results [ Time Frame: 16 weeks ]
    The results of a completed lung cancer screening CT, reported using the Lung-RADS classification

  9. Number of LCS false positives [ Time Frame: 1 year ]
    A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.

  10. Invasive procedures following LCS scan [ Time Frame: 1 year ]
    The proportion of patients in each arm who undergo an invasive procedure following a LCS scan

  11. Proportion of patients with complications following LCS [ Time Frame: 1 year ]
    The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan

  12. Overscreening [ Time Frame: 1 year ]
    The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.

  13. Reach of digital outreach strategy [ Time Frame: 16 weeks ]
    The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.

  14. Reach of mPATH-Lung program [ Time Frame: 16 weeks ]
    The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.

  15. Acceptability of mPATH-Lung program [ Time Frame: Up to 16 weeks after day of enrollment ]
    Patient mean score on the program acceptability survey

  16. Appropriateness of mPATH-Lung program [ Time Frame: 16 weeks after the last enrolled patient ]
    Primary care provider mean score on the program appropriateness survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet the Medicare criteria for lung cancer screening:

    • Age 55 - 77 years
    • Smoked at least 30 pack years
    • Current smoker or quit smoking within the past 15 years
  • Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
  • Have a patient portal account, cellphone number, or email address listed in the EHR

Exclusion Criteria:

  • Patients flagged as needing a language interpreter in the EHR
  • Those for whom LCS would be inappropriate:

    • Prior history of lung cancer
    • Chest CT within the last 12 months
    • Those with medical conditions predicting shorter life expectancy

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): NCT04083859


Contacts
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Contact: Diana E Flores 336-713-3103 dflores@wakehealth.edu

Locations
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United States, North Carolina
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Teri L Malo    919-445-6217    malotl@email.unc.edu   
Principal Investigator: Alison T Brenner, PhD         
Sub-Investigator: Dan Reuland, MD         
Sub-Investigator: Arlene Chung, MD         
Sub-Investigator: Teri L Malo, PhD         
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27101
Contact: Diana E Flores    336-713-3103    dflores@wakehealth.edu   
Principal Investigator: David P Miller, MD, MS         
Sub-Investigator: Kristie Foley, PhD         
Sub-Investigator: Ajay Dharod, MD         
Sub-Investigator: Christina Bellinger, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: David P Miller, MD, MS Wake Forest University Health Sciences
Publications:
American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019.
Centers for Medicare & Medicaid Services. Final National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N).; 2015. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed November 10, 2015.
Edwards A, Elwyn G. Shared Decision-Making in Health Care: Achieving Evidence-Based Patient Choice. Oxford: Oxford University Press; 2009.
Bangor A, Kortum PT, Miller JT. An Empirical Evaluation of the System Usability Scale. Int J Human-Computer Interact. 2008;24(6):574-594. doi:10.1080/10447310802205776

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04083859    
Other Study ID Numbers: IRB00060382
IRB00060382 ( Other Identifier: Institutional Review Board - Wake Forest University Health Science )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified individual participant data that underlie our published or presented results with researchers who provide a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
Supporting Materials: Study Protocol
Time Frame: We will make the de-identified data available within one year of the publication of the relevant results. Data will remain available for at least 5 years from the last publication of results.
Access Criteria: Researchers desiring data access must provide a methodologically sound proposal to the study principal investigator. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Mass screening
Early detection of cancer
Digital health interventions
Decision making, computer assisted
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases