Multilevel Intervention for Lung Cancer

(MIPO Trial)

Overseen By Daniel J Becker, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-lung, non-prostate cancer

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

Compensation: Varies

Number of Visits: Unknown

2653 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help doctors and patients use Precision Oncology more effectively, tailoring cancer treatment to individual genetic profiles. It includes three components: an educational video for patients, feedback to doctors about their treatment practices, and an improved system for ordering and reviewing test results. This multilevel intervention aims to determine if these changes enhance the ease and effectiveness of using personalized cancer treatments at VA medical centers. The trial seeks veterans with lung or prostate cancer who visit an oncology clinic. As an unphased trial, it offers veterans the opportunity to contribute to innovative approaches in personalized cancer care.

Will I have to stop taking my current medications?

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

What prior data suggests that this multilevel intervention is safe?

Research has shown that using multiple methods together, as in this trial, has been safe in various situations. One study focused on improving healthcare demonstrated that these methods improved lung cancer care by 25% without major safety issues. These methods often include educational videos, feedback for doctors, and updates to electronic systems to enhance efficiency.

Although specific safety data for this exact mix of methods is not available, using educational tools and system updates is generally very safe for participants. The researchers expect this approach to be well-tolerated. Participants typically find these methods easy to use, and they aim to improve care without introducing new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multilevel Intervention for lung cancer because it offers a comprehensive approach that combines patient education, provider feedback, and changes to electronic medical records (EMR). Unlike traditional treatments that primarily focus on medical therapies like chemotherapy, radiation, or surgery, this intervention aims to improve the overall healthcare delivery process. By educating patients, providing feedback to healthcare providers, and optimizing EMR systems, this method seeks to enhance the quality of care and potentially improve patient outcomes. This holistic strategy could lead to more personalized and efficient treatment for lung cancer patients, which is why it holds significant promise.

What evidence suggests that this multilevel intervention is effective for improving the use of Precision Oncology?

Research has shown that using multiple strategies can improve lung cancer care. One study found a 25% increase in lung cancer treatments when these strategies were applied. In this trial, all sites will receive a multilevel intervention that includes educating patients, providing feedback to healthcare providers, and simplifying access to medical records. Another study found that organized efforts can increase adherence to lung cancer screening, which is crucial for early detection. The intervention aims to remove obstacles, facilitating participation in personalized cancer care for both patients and doctors. Trials focused on lung cancer screening have proven these approaches safe and effective. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel J Becker, MD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for patients with lung or prostate cancer at 8 VA medical centers. It's designed to enhance Precision Oncology practices. Specific eligibility criteria are not provided, but typically participants would need a relevant cancer diagnosis.

Inclusion Criteria

I am a veteran with lung or prostate cancer being treated in the oncology clinic.

Exclusion Criteria

My cancer did not start in my prostate or lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a multilevel intervention including patient education, provider audit/feedback, and EMR order change

3 years

Follow-up

Participants are monitored for the use of molecular testing and targeted therapy

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Multilevel Intervention

Trial Overview

The study tests a three-part intervention: an educational video for patients, feedback for providers on their oncology practice patterns, and an electronic record change to streamline ordering and reviewing Precision Oncology tests.

How Is the Trial Designed?

Group I: During intervention period Experimental Treatment 1 Intervention

All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Recruited

15,900+

Martinsburg VA Medical Center

Collaborator

Trials

1

Recruited

2,700+

VA Iron Mountain Health Care

Collaborator

Trials

1

Recruited

2,700+

Northport VA Medical Center

Collaborator

Trials

1

Recruited

2,700+

Fargo VA Medical Center

Collaborator

Trials

2

Recruited

2,700+

VA Madison Health Care

Collaborator

Trials

1

Recruited

2,700+

New Orleans VA Medical Center

Collaborator

Trials

1

Recruited

2,700+

VA Eastern Oklahoma Health Care

Collaborator

Trials

1

Recruited

2,700+

Published Research Related to This Trial

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]

The U.S. Preventive Services Task Force recommends low-dose computed tomography for lung cancer screening in long-term smokers, highlighting its importance for early detection.

However, the implementation of lung cancer screening faces significant challenges, including patient and provider decision-making complexities, logistical issues, and sociopolitical barriers that need to be addressed for effective program development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Barriers to the Successful Implementation of Lung Cancer Screening: Why Does It Have to Be So Hard? Carter-Harris, L., Gould, MK.[2022]

A randomized controlled trial involving 496 participants (245 in the proactive counseling group and 251 in the control group) found that proactive telephone counseling did not significantly improve smoking cessation rates overall, but younger participants (<50 years) showed a higher cessation rate at 2 weeks (16% vs. 4%).

The study suggests that while proactive counseling aimed at teaching coping skills was challenging to implement, it may still hold potential for younger smokers in the social networks of lung cancer patients, indicating a need for further research to optimize such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Bastian, LA., Fish, LJ., Peterson, BL., et al.[2022]

In a study of 16,527 non-small cell lung cancer patients, the most common adverse events linked to pharmacotherapy were hypocalcemia, elevated creatine phosphokinase, and hypertriglyceridemia, highlighting the need for monitoring these conditions during treatment.

The modified Apriori algorithm proved to be more effective than the conventional method in identifying associations between chemotherapy drugs and adverse events, suggesting it could be a valuable tool for improving patient safety in cancer pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. Chen, W., Yang, J., Wang, HL., et al.[2022]

Patient-reported outcome (PRO) measures, such as quality of life assessments, are increasingly recognized as essential for evaluating treatment effectiveness in lung cancer clinical trials, which is crucial given lung cancer's high incidence and low survival rates.

The article highlights the importance of integrating electronic PRO reporting and interventions, as well as exploring the relationship between PROs and immunotherapy, to enhance clinical decision-making and precision health in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer. Xiao, C., Hurst, N., Movsas, B.[2021]

In a survey of 61 lung cancer survivors and caregivers, 74.5% prioritized cancer cure as the most important treatment goal, followed by quality of life during and after treatment.

70% of respondents considered treatment that leads to complete dependence on others or being confined to bed as unsuccessful, highlighting the need for physicians to discuss treatment goals and potential toxicities with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivor and Caregiver Expectations and Preferences Regarding Lung Cancer Treatment. Wieland, J., Hoppe, BS., Rausch-Osian, SM., et al.[2022]

In a study of 1,371 patients with advanced-stage non-small-cell lung cancer, 58% received chemotherapy, with younger patients (under 55) more likely to be treated compared to older patients (47% for those 75 and older).

Despite having fewer pre-treatment medical events, older patients experienced more adverse events during chemotherapy, indicating a need to carefully consider the balance between treatment benefits and potential side effects in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. Chrischilles, EA., Pendergast, JF., Kahn, KL., et al.[2021]

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11065591/

A pragmatic randomized clinical trial of multilevel interventions ...

This is the first randomized clinical trial to evaluate interventions to improve LCS adherence in US populations by addressing multilevel barriers.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714424000697

A pragmatic randomized clinical trial of multilevel ...

Ten-year results of the multicentric Italian lung detection trial demonstrate the safety and efficacy of biennial lung cancer screening. Eur. J. Cancer. (2019).

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03862001

Lung Cancer Screening: A Multilevel Intervention

The study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2831672

Adherence to Follow-Up Lung Cancer Screening

Of 10 170 participants who received baseline LDCT, 84.5% had negative screening results and 15.5% had positive screening results. Adherence at ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.6518

A multi-level system quality improvement project to reduce ...

Results: With the implementation of these multi-level interventions, there was a twenty five percent improvement in the number of lung cancer ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03862001

Lung Cancer Screening: A Multilevel Intervention

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9420764/

A Multilevel Approach to Investigate Relationships ...

Using New York state SEER data, we identified 68,990 lung cancer patients aged 20 to 112; 48.3% had late-stage lung cancers, and the average lung cancer ...