Patient Empowerment Interventions for Lung Cancer Screening

(Empower-LCS Trial)

Not currently recruiting at 6 trial locations

Overseen By Agnes Zhou

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Lung cancer, Chest CT, Alzheimer's, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase lung cancer screening using a special low-dose CT scan. It focuses on ensuring that patients and their doctors are informed about lung cancer screening and have the necessary tools to proceed. Participants will receive educational materials, financial resource referrals, and reminders to discuss screening with their doctors. This trial suits individuals with a significant smoking history who have an upcoming doctor's appointment. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance lung cancer screening practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for lung cancer screening?

Research has shown that programs designed to encourage lung cancer screening are generally safe. These programs typically include education, reminders, and referrals to resources. So far, no negative effects have been reported from these types of programs.

The main goal is to empower patients and inform healthcare providers, strategies that people generally handle well. These programs aim to improve communication and access to screening without any physical or medical risk. Since they do not involve physical procedures or medications, the risk of harm remains very low.

Studies have found that these methods effectively increase lung cancer screening rates, potentially saving lives. Overall, this approach is very safe because it focuses on providing information and support rather than direct medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Empower LCS" approach because it aims to boost lung cancer screening rates by directly addressing barriers that patients face. Unlike traditional methods that focus solely on physician-driven referrals, this treatment empowers patients by providing educational materials to overcome knowledge gaps, offering referrals to financial assistance to mitigate economic concerns, and sending reminders to discuss screenings with their primary care providers. By enhancing patient engagement and addressing social and financial obstacles, this method could significantly increase early detection of lung cancer, potentially leading to better outcomes.

What evidence suggests that this intervention is effective for increasing lung cancer screening uptake?

Research has shown that screening for lung cancer with low-dose CT scans can reduce deaths from the disease by 20%. In this trial, participants will receive interventions designed to empower them in the screening process. Studies have found that when patients feel more in control, more people choose to get screened. These efforts often include educating patients, informing doctors of patient eligibility, and offering financial advice. Such steps have effectively increased the number of people who undergo screening. By detecting lung cancer early, these methods can greatly improve survival rates. ^{1 2 3 6 7}

Who Is on the Research Team?

Gelareh Sadigh, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for English, Spanish, or Vietnamese speakers aged 50-80 who are current smokers or quit within the last 15 years. They must have a history of heavy smoking (20 pack-years), an upcoming primary care appointment at UCI Health in Orange County, and no prior lung cancer or recent chest CT scans.

Inclusion Criteria

I am between 50 and 80 years old.

I have an appointment with my primary care doctor in the next 1-3 months.

History of 20 pack year smoking history (based on survey self-report)

Exclusion Criteria

History of Alzheimer's disease or dementia

I have had a chest CT scan in the last year.

I have had lung cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education materials, referral to financial navigation resources, and reminders to discuss LCS during PCP visits. Providers are notified of patient eligibility for LCS.

6 months

Ongoing interaction with primary care providers

Follow-up

Participants are monitored for receipt of LDCT and self-efficacy for lung cancer screening, as well as perceived risk, severity, and benefits of lung cancer screening.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Empowering Patients' Lung Cancer Screening Uptake

Trial Overview The study tests if reminders to doctors and patients about lung cancer screening eligibility, patient education on lung cancer screening, financial navigation help, and reminders to discuss screening can increase low dose CT scan orders within six months after enrolling.

How Is the Trial Designed?

Group I: Empower LCS Experimental Treatment 4 Interventions

Patient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

The review identified 33 questionnaires measuring empowerment in cancer patients, but only four were specifically designed to assess empowerment, highlighting a significant gap in comprehensive tools for this purpose.

Most of the included questionnaires focused on related concepts like patient-centered care and self-efficacy, indicating that while there are tools available, they may not fully capture the unique aspects of patient empowerment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment: a systematic review of questionnaires measuring empowerment in cancer patients. Eskildsen, NB., Joergensen, CR., Thomsen, TG., et al.[2022]

In a study involving 237 lung cancer screening patients, both Option Grids and Shouldiscreen.com were effective in facilitating shared decision making (SDM), but Option Grids led to lower decision regret and better understanding of potential complications compared to Shouldiscreen.com.

Patients using Shouldiscreen.com reported less knowledge about complications and had higher decision regret regarding their choice to pursue screening, highlighting the importance of the decision aid used in the SDM process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. Sferra, SR., Cheng, JS., Boynton, Z., et al.[2021]

A novel decision support intervention (DSI) for patients with late-stage non-small cell lung cancer (NSCLC) was developed, which includes care plan cards and a patient preference tool to facilitate shared decision making about treatment options.

Pilot testing with five patients showed that using the DSI increased awareness of treatment options and their benefits/risks, while reducing concerns about treatment costs and decision-making uncertainty, indicating its potential effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. Myers, RE., Advani, SM., Myers, P., et al.[2021]

A single-page, paper-based encounter decision aid (EDA) used during shared decision-making visits for lung cancer screening significantly reduced patient decisional conflict, as indicated by a drop in the Decisional Conflict Scale score from 35.0 to 0.2 (p < 0.001).

While 28% of patients understood the mortality benefit of lung cancer screening after the visit, a much higher percentage (82%) grasped the frequency of abnormal screening results, highlighting the need for improved patient education on the mortality benefits of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. Ito Fukunaga, M., Balwan, A., Janis, JA., et al.[2023]

Citations

1. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06000683

Empowering Patients' Lung Cancer Screening Uptake Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet many patients who are ...

2. withpower.com withpower.com/trial/phase-lung-neoplasms-7-2023-3d363

Patient Empowerment Interventions for Lung Cancer ... What data supports the effectiveness of the treatment Empowering Patients' Lung Cancer Screening Uptake? Research on patient empowerment in cancer care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904607/

Review of Interventions That Improve Uptake of Lung Cancer ... Lung cancer screening (LCS) has the potential to decrease mortality from lung cancer by 20%. Yet, more than a decade since LCS was established as an ...

4. rsna.org rsna.org/research/funding-opportunities/emerging-issues-grant/rsna-health-equity-committee-re-foundation

RSNA Health Equity Committee/R&E Foundation Lung cancer screening (LCS) with low-dose computed tomography (LCDT) decreases the mortality rate of lung cancer by 20%, when compared with chest X-ray alone, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666364323000085

Interventions Designed to Increase the Uptake of Lung ... Interventions that were most effective in improving access to LCS targeted priority populations, raised community-level awareness, tailored materials for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0169500225003769

Identifying and exploring patient engagement interventions ... This is the first study to synthesise engagement interventions in lung cancer. A range of interventions were identified showing improvements in several ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-23808-8

Facilitators and barriers of lung cancer screening participation Understanding factors associated with uptake of lung cancer screening among individuals at high risk. J Health Care Poor Underserved. 2023 ...