Clinical trial · Interventional
The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
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
NCT06338592CI-TRIAL-00106596MyLungHealthcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasms/Diagnosis | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DecisionPrecision+ | Behavioral | — | UNRESOLVED |
| MyLungHealth | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Study 1 (Study of Patients with Uncertain LCS Eligibility) Control Arm
- description
- In 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.
- type
- EXPERIMENTAL
- label
- Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm
- description
- Patients 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion criteria for both study 1 and study 2: * 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 Exclusion criteria for both study 1 and study 2: * \>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 Inclusion criteria for study 1: * 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 Inclusion criteria for study 2: * at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years
References
Publications (4)
- BACKGROUNDKukhareva 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. PMID 37142092
- DERIVEDBalbin 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. PMID 42166800
- DERIVEDKukhareva 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. PMID 41452617
- DERIVEDKukhareva 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. PMID 39806641