Multilevel Interventions for Lung Cancer Screening Adherence

(Larch Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Lung cancer, Positive scan, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1837 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for improving lung cancer screening adherence?

Research shows that patient education and reminders can improve adherence to medical protocols. For example, a study on breast cancer found that educational materials helped women stick to their treatment plans, suggesting similar strategies might help with lung cancer screening adherence. ^{1 2 3 4 5}

How does the treatment for improving lung cancer screening adherence differ from other treatments?

This treatment is unique because it involves multilevel interventions designed to improve adherence to lung cancer screening, focusing on factors like patient motivation, proximity to screening centers, and personalized interventions such as nursing support, rather than a specific drug or medical procedure. ^{1 2 3 4 6}

Research Team

Karen Wernli, PhD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for individuals aged 50-78 who have had a negative lung screening scan, speak English or Spanish, and meet US Preventive Services Task Force guidelines. They must be members of KPWA. People with previous lung cancer diagnoses or those needing an interpreter other than for Spanish are excluded.

Inclusion Criteria

I speak English or Spanish.

You had a recent scan that did not show any signs of lung cancer.

I am between 50 and 78 years old.

Exclusion Criteria

Patients who have an indicator for interpreter services, except for Spanish

I was previously diagnosed with lung cancer.

Patients who have a positive result on a scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive patient education and reminders to improve adherence to lung cancer screening

8 weeks

1 visit (in-person), multiple virtual interactions

Follow-up

Participants are monitored for adherence to repeat annual lung cancer screening

9-15 months

Treatment Details

Interventions

• Patient Education
• Stepped Reminders

Trial Overview The study is examining the effectiveness of patient education combined with stepped reminders to improve adherence to annual lung cancer screenings among eligible participants.

Participant Groups

Group I: Stepped Reminders only Experimental Treatment 1 Intervention

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 II: Patient Video only Experimental Treatment 1 Intervention

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 III: Patient Video and Stepped Reminders Experimental Treatment 2 Interventions

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

Group IV: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Findings from Research

In a study of 901 high-risk patients undergoing CT lung cancer screening, 85.7% adhered to radiologist follow-up recommendations, indicating that high adherence rates are achievable in clinical settings.

The main reasons for nonadherence included patient refusal for follow-up exams (66.7%) and difficulties in contacting patients (20.9%), highlighting areas for improvement in patient engagement and communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. Alshora, S., McKee, BJ., Regis, SM., et al.[2018]

In a study of 2089 members from Kaiser Permanente Washington, only 26.4% adhered to on-time repeat lung cancer screenings after an initial negative low-dose computed tomography (LDCT) scan, which improved to 43.1% for subsequent scans, highlighting significant gaps in screening adherence.

Key factors for improving adherence included making screenings more personalized and convenient, providing consistent reminders, enhancing patient knowledge about the screening process, and implementing both financial and non-financial incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening. Wernli, KJ., Tuzzio, L., Brush, S., et al.[2022]

In a study of 337 patients with low-risk Lung-RADS scores, 73.5% of those with a score of 1 and 75.0% with a score of 2 adhered to annual lung cancer screening, indicating a high adherence rate in a centralized screening program.

Medicaid coverage was identified as a significant factor affecting adherence, with Medicaid patients being less likely to complete annual screenings compared to those with private insurance, highlighting potential socioeconomic barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Annual Lung Cancer Screening in a Centralized Academic Program. Lee, G., Hill, LP., Schroeder, MC., et al.[2023]

In a study involving 2757 postmenopausal women with hormone receptor-positive early-stage breast cancer, educational materials did not improve treatment compliance with aromatase inhibitors over a 2-year period, with compliance rates remaining similar between groups (82% for both).

The main reason for treatment discontinuation (9% of patients) was side effects related to aromatase inhibitors, highlighting that patient experiences and side effects significantly influence compliance and persistence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. Markopoulos, C., Neven, P., Tanner, M., et al.[2018]

In a study of 30,166 lung cancer screening patients across 14 health systems, only 48.4% adhered to follow-up screenings in the first year, and this dropped to 44.4% in the second year, indicating a significant gap in adherence despite eligibility.

Among the eligible patients, 93 were diagnosed with lung cancer, mostly during the first follow-up, highlighting the importance of improving adherence to screening programs to maximize their potential mortality benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Annual Adherence to Lung Cancer Screening in a Large National Cohort. Smith, HB., Schneider, E., Tanner, NT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to Annual Lung Cancer Screening in a Centralized Academic Program. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Factors determining early adherence to a lung cancer screening protocol. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

An Evaluation of Annual Adherence to Lung Cancer Screening in a Large National Cohort. [2022]