Lung CancerLarchNCT05747443
Multilevel Interventions to Increase Adherence to Lung Cancer Screening
A study testing Stepped Reminders and Patient Education in people with Lung Cancer and Lung Cancer Screening, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 78 years
- Conditions the study is for
- Lung Cancer, Lung Cancer Screening
- What is being tested?
- Stepped Reminders and Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,837 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- KPWA members
- Aged 50-78 years
- Have a negative screening LDCT scan
- Speak English or Spanish
- Meet US Preventive Services Task Force guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Cancer, Lung Cancer Screening
- Being tested
- Stepped Reminders, Patient Education
- Keywords
- Lung Cancer, Low dose CT (LDCT), Lung Cancer Screening, Stepped Reminders, Educational Video, User centered design, Stakeholders, Evaluation, Qualitative, Patient Partners, Adherence
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped RemindersOther
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.
Patient EducationOther
The Patient Voices Video is an educational video about lung cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Patient Video only | Experimental | 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. Receives: Other: Patient Education |
| Stepped Reminders only | Experimental | 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. Receives: Other: Stepped Reminders |
| Patient Video and Stepped Reminders | Experimental | See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above. Receives: Other: Stepped Reminders; Other: Patient Education |
| Usual Care | No intervention | Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of repeat annual lung cancer screening
Electronic health records will be searched for screening low dose CT (LDCT).
Measured: 9-15 months after index LDCT
Secondary outcomes (2)
Knowledge of lung cancer screening
Knowledge of lung cancer screening eligibility, time to return and cost on patient reported outcomes survey.
Measured: 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.
Measured: 8 weeks after index LDCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start12 Dec 2022
- Primary completion5 Jul 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Hackensack Meridian Health
- Responsible party
- Sponsor
- Investigators
- Karen Wernli, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747443
- Sponsor's protocol ID
- 220-115.001
- Acronym
- Larch
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palazzo L, Luce C, Vasavada A, Mettert K, Gao H, Ralston JD, Bezman N, Green BB, Rogers K, Anderson ML, Su YR, Triplette M, Carter-Bawa L, Wernli KJ. I need it. Without it, I wouldn't have gone, and I do want to go: patient perspectives on the acceptability and appropriateness of two patient-centered interventions to improve adherence to annual lung cancer screening. Front Health Serv. 2026 Sep 23;6:1810956. doi: 10.3389/frhs.2026.1810956. eCollection 2026.
PubMed 42846115Wernli KJ, Anderson ML, Palazzo L, Luce C, Bezman N, Rogers K, Chin M, Gao H, Ralston J, Su YR, Carter-Bawa L, Triplette M, Tuzzio L, Vasavada A, Green BB. Health Communication and Stepped Reminders Interventions for Lung Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 10. doi: 10.1001/jamainternmed.2026.3666. Online ahead of print.
PubMed 42574003Vasavada 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. Understanding older adults' perceptions and attitudes toward digital health and technology in a lung cancer screening-eligible population: a qualitative study. BMC Health Serv Res. 2026 Jul 21. doi: 10.1186/s12913-026-15124-7. Online ahead of print.
PubMed 42482048Vasavada 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.
PubMed 41333381Wernli 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. 2026 Feb;169(2):550-561. doi: 10.1016/j.chest.2025.07.4111. Epub 2025 Sep 10.
PubMed 40939933Luce 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.
PubMed 38467273
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Interventions to Increase Adherence to Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT05747443
- Acronym / sponsor ID
- Larch / 220-115.001
- Conditions
- Lung Cancer, Lung Cancer Screening
- Keywords
- Lung Cancer, Low dose CT (LDCT), Lung Cancer Screening, Stepped Reminders, Educational Video, User centered design, Stakeholders, Evaluation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,837 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Hackensack Meridian Health
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient Video only | Experimental | Other: Patient EducationAbout 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. |
| Stepped Reminders only | Experimental | Other: Stepped RemindersPrior 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. |
| Patient Video and Stepped Reminders | Experimental | Other: Stepped Reminders, Other: Patient EducationSee above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above. |
| Usual Care | No intervention | –Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care. |
Who may qualify
- Ages
- 50 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- KPWA members
- Aged 50-78 years
- Have a negative screening LDCT scan
- Speak English or Spanish
- Meet US Preventive Services Task Force guidelines
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped RemindersStepped 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. | Other | Patient Video and Stepped Reminders, Stepped Reminders only |
| Patient EducationThe Patient Voices Video is an educational video about lung cancer screening. | Other | Patient Video and Stepped Reminders, Patient Video only |
Primary outcome
Rate of repeat annual lung cancer screening
Time frame: 9-15 months after index LDCT
Electronic health records will be searched for screening low dose CT (LDCT).
2 secondary outcomes
Knowledge of lung cancer screening
Time frame: 8 weeks after index LDCT
Attitudes and beliefs
Time frame: 8 weeks after index LDCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 42846115Palazzo L, Luce C, Vasavada A, Mettert K, Gao H, Ralston JD, Bezman N, Green BB, Rogers K, Anderson ML, Su YR, Triplette M, Carter-Bawa L, Wernli KJ. I need it. Without it, I wouldn't have gone, and I do want to go: patient perspectives on the acceptability and appropriateness of two patient-centered interventions to improve adherence to annual lung cancer screening. Front Health Serv. 2026 Sep 23;6:1810956. doi: 10.3389/frhs.2026.1810956. eCollection 2026.
- Derived from this study: PubMed 42574003Wernli KJ, Anderson ML, Palazzo L, Luce C, Bezman N, Rogers K, Chin M, Gao H, Ralston J, Su YR, Carter-Bawa L, Triplette M, Tuzzio L, Vasavada A, Green BB. Health Communication and Stepped Reminders Interventions for Lung Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 10. doi: 10.1001/jamainternmed.2026.3666. Online ahead of print.
- Derived from this study: PubMed 42482048Vasavada 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. Understanding older adults' perceptions and attitudes toward digital health and technology in a lung cancer screening-eligible population: a qualitative study. BMC Health Serv Res. 2026 Jul 21. doi: 10.1186/s12913-026-15124-7. Online ahead of print.
- Derived from this study: PubMed 41333381Vasavada 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.
- Derived from this study: PubMed 40939933Wernli 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. 2026 Feb;169(2):550-561. doi: 10.1016/j.chest.2025.07.4111. Epub 2025 Sep 10.
- Derived from this study: PubMed 38467273Luce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Wernli, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Reminders and Patient Education in people with Lung Cancer and Lung Cancer Screening, run by Kaiser Permanente at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of repeat annual lung cancer screening (time frame: 9-15 months after index LDCT). 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 NCT05747443, which also lists 6 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 24 Dec 2025.