Multilevel Interventions to Increase Adherence to Lung Cancer Screening

NCT ID: NCT05747443

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1837 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Lung Cancer Lung Cancer Screening

Keywords

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Lung Cancer Low dose CT (LDCT) Lung Cancer Screening Stepped Reminders Educational Video User centered design Stakeholders Evaluation Qualitative Patient Partners Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient Education

Intervention Type OTHER

The Patient Voices Video is an educational video about lung cancer screening.

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.

Group Type EXPERIMENTAL

Stepped Reminders

Intervention Type OTHER

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 Video and Stepped Reminders

See above. Those assigned to the Patient Video and Stepped Reminders will receive both interventions, as described above.

Group Type EXPERIMENTAL

Stepped Reminders

Intervention Type OTHER

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 Education

Intervention Type OTHER

The Patient Voices Video is an educational video about lung cancer screening.

Usual Care

Those assigned to the the Usual Care arm will continue to receive usual lung cancer screening care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Patient Education

The Patient Voices Video is an educational video about lung cancer screening.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

Hackensack Meridian Health

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Wernli, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41333381 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40939933 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38467273 (View on PubMed)

Other Identifiers

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220-115.001

Identifier Type: -

Identifier Source: org_study_id