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Lung CancerMyLungHealthNCT06338592

The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale

A study testing MyLungHealth and DecisionPrecision+ in people with Lung Cancer and Lung Neoplasms/Diagnosis, run by University of Utah at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. Read more about this study

Who is it for?
Ages 50 to 79 years
Conditions the study is for
Lung Cancer, Lung Neoplasms/Diagnosis
What is being tested?
MyLungHealth and DecisionPrecision+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31,303 participants
Where
2 sitesUnited States
Study dates
28 Mar 2024to 28 Jan 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 50-79
  • a history of smoking (e.g., current or former tobacco use)
  • seen in a study primary care clinic in the 12 months preceding the start of the trial
  • a 10-19 pack-year smoking history, an unknown pack-year history, unknown quit date for patients who quit smoking, or a 0 pack-year smoking history
  • at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years

Who cannot join

  • >0 but < 10 pack-year smoking history or quit more than 15 years ago
  • No use of the patient portal at least once in the year preceding the start of the study
  • A lung cancer diagnosis at the start of the study
  • LDCT completed in the past 3 years
  • Another chest CT completed in the past year
  • Structured EHR data indicating LCS SDM was provided in the past 3 years
  • Exposed to the intervention during the pilot phase
  • No visit at a study clinic during the trial period when the intervention was available

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • NYU Langone Health

    New York, New York, 10016

  • University of Utah Health

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: The MyLungHealth Study Protocol: A Pragmatic Patient-Randomized Controlled Trial to Evaluate a Patient-Centered, Electronic Health Record-Integrated Intervention to Enhance Lung Cancer Screening in Primary Care

Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making.

Read the detailed description

MyLungHealth is a multi-site pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. The intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused clinical decision support and shared decision-making intervention) against DecisionPrecision+ alone.

Being tested
MyLungHealth, DecisionPrecision+
Medical subject headings
Lung Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyLungHealthBehavioural

    MyLungHealth is a patient-centered, EHR-integrated smoking data-quality improvement and education intervention. A key component of the MyLungHealth intervention is a pre-visit LCS eligibility questionnaire asked through the Epic EHR patient portal for individuals with unclear LCS eligibility due to missing or potentially inaccurate data in the EHR. Another key component of the MyLungHealth intervention is an interoperable, patient-centered educational app delivered through the EHR patient portal.

  • DecisionPrecision+Behavioural

    DecisionPrecision+ is a multi-faceted intervention which includes provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders.

Study groups in NCT06338592
Study groupRoleWhat they receive
Study 1 (Study of Patients with Uncertain LCS Eligibility) Control ArmNo interventionIn Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention ArmExperimentalPatients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
Receives: Behavioral: MyLungHealth
Study 2 (Study of Patients with Documented LCS Eligibility) Control ArmActive comparatorIn Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders.
Receives: Behavioral: DecisionPrecision+
Study 2 (Study of Patients with Documented LCS Eligibility) Intervention ArmExperimentalPatients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
Receives: Behavioral: MyLungHealth; Behavioral: DecisionPrecision+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening

    In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal.

    Measured: 1 year trial period

  2. Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered.

    In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data.

    Measured: 1 year trial period

Secondary outcomes (4)
  1. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known.

    In Study 1, which enrolled participants with uncertain lung cancer screening eligibility at baseline, a secondary outcome was the count of participants for whom lung cancer screening eligibility status became known during the 12-month follow-up period, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal.

    Measured: 1 year trial period

  2. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered.

    Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial.

    Measured: 1 year trial period

  3. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.

    Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial.

    Measured: 1 year trial period

  4. Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.

    A secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial.

    Measured: 1 year trial period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start28 Mar 2024
  3. Primary completion27 Mar 2025
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a patient randomized trial that includes two sub-studies, with 2 arms each.
Masking
None (open label)
Enrolment
31,303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06338592
Sponsor's protocol ID
UUtah_00153806
Acronym
MyLungHealth
Status last verified
Mar 2026
First submitted
18 Mar 2024
Last updated
27 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: On completion, study data will be made available in compliance with institutional and sponsor data sharing policies.

Publications

  • Kukhareva PV, Li H, Caverly TJ, Del Fiol G, Fagerlin A, Butler JM, Hess R, Zhang Y, Taft T, Flynn MC, Reddy C, Martin DK, Warner IA, Rodriguez-Loya S, Warner PB, Kawamoto K. Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts. Chest. 2023 Nov;164(5):1325-1338. doi: 10.1016/j.chest.2023.04.040. Epub 2023 May 3.

    PubMed 37142092
  • Balbin CA, Stevens L, Dalrymple R, Tiase VL, Kaphingst KA, Stevens ER, Kukhareva PV, Caverly TJ, Del Fiol G, Mann D, Kwon J, Fagerlin A, Butler JM, Kawamoto K. MyLungHealth, a Patient-Facing Education Tool for Lung Cancer Screening: Qualitative User-Centered Design Study. JMIR Form Res. 2026 May 21;10:e83033. doi: 10.2196/83033.

    PubMed 42166800
  • Kukhareva PV, Li H, Balbin C, Stevens ER, Mann DM, Butler JM, Caverly TJ, Del Fiol G, Kaphingst KA, Schlechter CR, Tiase VL, Fagerlin A, Zhang Y, Hess R, Flynn MC, Reddy C, Martin D, Warner PB, Nanjo C, Choi J, Ngo-Metzger Q, Kawamoto K. Enhancement of Patient-Centered Lung Cancer Screening: The MyLungHealth Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):167-176. doi: 10.1001/jamaoncol.2025.5672.

    PubMed 41452617
  • Kukhareva P, Balbin C, Stevens E, Mann D, Tiase V, Butler J, Del Fiol G, Caverly T, Kaphingst K, Schlechter CR, Fagerlin A, Li H, Zhang Y, Hess R, Flynn M, Reddy C, Warner P, Choi J, Martin D, Nanjo C, Metzger Q, Kawamoto K. The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care. BMJ Open. 2024 Dec 22;14(12):e087056. doi: 10.1136/bmjopen-2024-087056.

    PubMed 39806641

Questions about this trial

What is this clinical trial studying?

A study testing MyLungHealth and DecisionPrecision+ in people with Lung Cancer and Lung Neoplasms/Diagnosis, run by University of Utah at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening (time frame: 1 year trial period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06338592, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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