Patient Empowerment Interventions for Lung Cancer Screening

(Empower-LCS Trial)

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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet many patients who are eligible for lung cancer screening are still falling through the cracks which prevents patients the ability to detect lung cancer early. This study will test the effect of a a multi-level intervention on ordering LDCT within 6 months after patient enrollment. Our proposed intervention includes (1) Primary care provider notifications of patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial navigation resources; and (4) patients' reminder to discuss LCS during PCP visit.

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 data supports the effectiveness of the treatment Empowering Patients' Lung Cancer Screening Uptake?

Research on patient empowerment in cancer care shows that feeling in control and having mastery over one's health can improve decision-making and participation in treatment. This suggests that empowering patients could help increase their participation in lung cancer screening. ^{1 2 3 4 5}

Is the Patient Empowerment Intervention for Lung Cancer Screening safe for humans?

The available research on decision support interventions for lung cancer screening, which includes tools to help patients make informed choices, suggests that these interventions are generally safe. They are designed to increase patient awareness and reduce uncertainty about treatment options without causing distress. ^{5 6 7 8 9}

How does the patient empowerment treatment for lung cancer screening differ from other treatments?

This treatment is unique because it focuses on empowering patients to take an active role in managing their health, helping them feel more in control of their illness. Unlike traditional treatments that focus solely on medical interventions, this approach emphasizes personal growth and self-management, allowing patients to redefine their experience with cancer as empowering rather than solely threatening. ^{1 2 3 4 10}

Research Team

Gelareh Sadigh, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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.

I can speak English, Spanish, or Vietnamese.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Lung Cancer Screening Participation: Developing a Conceptual Model to Guide Research. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

Patient Empowerment Among Adults With Arthritis: The Case for Emotional Support. [2022]

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

The psychometrics of developing the patient empowerment scale. [2019]

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

Patient empowerment: a systematic review of questionnaires measuring empowerment in cancer patients. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. [2021]

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

Patients' Attitudes Regarding Lung Cancer Screening and Decision Aids. A Survey and Focus Group Study. [2018]

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

"It's a decision I have to make": Patient perspectives on smoking and cessation after lung cancer screening decisions. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Aiding shared decision making in lung cancer screening: two decision tools. [2021]

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

Empowering Cancer Survivors in Managing Their Own Health: A Paradoxical Dynamic Process of Taking and Letting Go of Control. [2023]