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

Trial Summary

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 data supports the effectiveness of the Multilevel Intervention treatment for lung cancer?

The research highlights the importance of patient-reported outcomes (PROs) like quality of life in evaluating treatment effectiveness for lung cancer, suggesting that treatments improving these outcomes can be considered effective. Additionally, improvements in chemotherapy options for lung cancer have shown to enhance survival and quality of life, indicating that similar approaches in multilevel interventions could be beneficial. ^{1 2 3 4 5}

Is the Multilevel Intervention for Lung Cancer safe for humans?

The safety of treatments for lung cancer, like PD-1/PD-L1 inhibitors, has been studied, showing they can cause immune-related side effects, some of which may be serious. These treatments are generally considered safe, but they can have adverse effects, especially when combined with other therapies. ^{6 7 8 9 10}

How is the Multilevel Intervention treatment for lung cancer unique?

The Multilevel Intervention treatment for lung cancer is unique because it addresses various barriers to effective lung cancer care, such as stigma and adherence to screening, by involving multiple levels of influence, including individual, social, and healthcare system factors. This approach aims to improve outcomes by considering the broader context of a patient's environment and healthcare interactions. ^{11 12 13 14 15}

What is the purpose of this trial?

The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

Research Team

Daniel J Becker, MD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

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

An International Consensus on Actions to Improve Lung Cancer Survival: A Modified Delphi Method Among Clinical Experts in the International Cancer Benchmarking Partnership. [2022]

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

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer. [2021]

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

Survivor and Caregiver Expectations and Preferences Regarding Lung Cancer Treatment. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Victorian Lung Cancer Service Redesign Project: impacts of a quality improvement collaborative on timeliness and management in lung cancer. [2022]

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Advances in cytotoxic chemotherapy for the treatment of metastatic or recurrent non-small cell lung cancer. [2019]

6. Germany 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. [2021]

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

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. [2022]

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

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. [2021]

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

Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post-authorization safety cohort study conducted in Europe and in the United States. [2021]

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

A model-based meta-analysis of immune-related adverse events during immune checkpoint inhibitors treatment for NSCLC. [2022]

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

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. [2022]

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

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

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

Multilevel Barriers to the Successful Implementation of Lung Cancer Screening: Why Does It Have to Be So Hard? [2022]

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

Multilevel Opportunities to Address Lung Cancer Stigma across the Cancer Control Continuum. [2023]

15. Ireland pubmed.ncbi.nlm.nih.gov

Are working practices of lung cancer nurse specialists associated with variation in peoples' receipt of anticancer therapy? [2019]