Multilevel Interventions to Increase Adherence to Lung Cancer Screening (Larch)

Screening for lung cancer has the potential for a profound public health benefit. Repeat annual screening is necessary for early detection of lung cancer. The investigators will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Lung Cancer Screening
• Intervention / Treatment: Other: Patient Education; Other: Stepped Reminders

Detailed Description

Screening for lung cancer has the potential for a profound public health benefit.

Successful population-based screening requires continuous monitoring to adherence repeat screening in high risk adults to achieve similar results. Repeat annual screening is necessary for early detection of lung cancer. Baseline or first LDCT scans detect prevalent lung cancer, when subsequent screening detects new nodules. However, adherence to screening is low, ranging at 28-38% from centers nationally.

The investigators developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address these goals, the specific aims are to: 1) Compare effectiveness of two multilevel interventions relative to usual care in improving (a) rates of adherence to lung cancer screening, (b) patient-centered outcomes; and (c) clinic outcomes; and 2) Determine the patient-, clinician-, and system-level factors that influence changes in adherence to inform lung cancer screening programs.

• Study Type: Interventional
• Enrollment (Actual): 1837
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• KPWA members
• Aged 50-78 years
• Have a negative screening LDCT scan
• Speak English or Spanish
• Meet US Preventive Services Task Force guidelines

Exclusion Criteria:

• Patients who were previously diagnosed with lung cancer,
• Patients who have a positive scan,
• Patients who have an indicator for interpreter services, except for Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Video only; About 3 weeks after the index LDCT, the study Medical Assistant (MA) will deliver a link to the Patient Voices Video, an educational video about lung cancer screening.	Other: Patient Education; The Patient Voices Video is an educational video about lung cancer screening.
Experimental: Stepped Reminders only; Prior to patient's next LDCT scan is due, MA begins Stepped Reminders intervention: MA pends LDCT orders to PCP to sign. MA sends reminders to patient when order is placed and follows up by phone if patient has not scheduled LDCT.	Other: Stepped Reminders; Stepped Reminders, which directly reminds providers to order the next LDCT scan and then reminds patients they are due and prompts them to schedule LDCT with Radiology.
Experimental: Patient Video and Stepped Reminders; See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.	Other: Patient Education; The Patient Voices Video is an educational video about lung cancer screening.; Other: Stepped Reminders; Stepped Reminders, which directly reminds providers to order the next LDCT scan and then reminds patients they are due and prompts them to schedule LDCT with Radiology.
No Intervention: Usual Care; Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of repeat annual lung cancer screening	Electronic health records will be searched for screening low dose CT (LDCT).	9-15 months after index LDCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of lung cancer screening	Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.	8 weeks after index LDCT
Attitudes and beliefs	The Lung Cancer Screening Health Belief Scale measures self-efficacy for lung cancer screening. The self-efficacy for lung cancer screening scale ranges from 9-36, with higher scores indicating lower self-efficacy.	8 weeks after index LDCT

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Fred Hutchinson Cancer Center; Hackensack Meridian Health
• Investigators: Principal Investigator: Karen Wernli, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Vasavada A, Palazzo L, Luce C, Sanchez M, Triplette M, Ralston JD, Carter-Bawa L, Green BB, Gao H, Li CI, Anderson ML, Su YR, Rogers K, Wernli KJ. "It's coming whether we want it to or not": A qualitative exploration of older adults' comfort with and perceptions of technology and digital health. Res Sq [Preprint]. 2025 Nov 19:rs.3.rs-8001649. doi: 10.21203/rs.3.rs-8001649/v1.
• Wernli KJ, Anderson ML, Palazzo L, Luce C, Bezman N, Chin M, Gao H, Ralston JD, Rogers K, Su YR, Triplette M, Carter-Bawa L, Vasavada A, Jordan M, West M, Boler S, Green BB. Effectiveness of Health Communication Intervention to Improve Knowledge on Timeliness to Return for Annual Lung Cancer Screening: The Larch Trial. Chest. 2025 Sep 10:S0012-3692(25)05173-6. doi: 10.1016/j.chest.2025.07.4111. Online ahead of print.
• Luce C, Palazzo L, Anderson ML, Carter-Bawa L, Gao H, Green BB, Ralston JD, Rogers K, Su YR, Tuzzio L, Triplette M, Wernli KJ. A pragmatic randomized clinical trial of multilevel interventions to improve adherence to lung cancer screening (The Larch Study): Study protocol. Contemp Clin Trials. 2024 May;140:107495. doi: 10.1016/j.cct.2024.107495. Epub 2024 Mar 11.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): July 5, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Adherence; Lung Cancer; Qualitative; Evaluation; Lung Cancer Screening; Stakeholders; Educational Video; Low dose CT (LDCT); Stepped Reminders; User centered design; Patient Partners
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID Numbers: 220-115.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No