Telehealth Strategies for Lung Cancer Screening

(ITALCS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Katharine Rendle, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Lung cancer, Recent screening, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are: 1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS? 2. Is the effectiveness of these telehealth strategies similar by race and sex? The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

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 treatment Integrating Telehealth to Advance Lung Cancer Screening?

The use of telemedicine in lung cancer screening, particularly through shared decision-making, is being explored to improve screening completion rates. Additionally, successful implementation of lung screening programs in different healthcare systems highlights the potential for telehealth to enhance early detection and treatment of lung cancer. ^{1 2 3 4 5}

Is telehealth for lung cancer screening safe for humans?

The studies reviewed focus on lung cancer screening using low-dose CT scans, which are generally safe but can have potential harms like false-positive results and procedural complications. However, no major complications were reported in the studies, suggesting that the screening process is generally safe. ^{6 7 8 9 10}

How does the treatment 'Integrating Telehealth to Advance Lung Cancer Screening' differ from other treatments for lung cancer screening?

This treatment is unique because it uses telehealth to provide counseling, follow-up care, and smoking cessation support remotely, while the actual lung cancer screening is done in-person with a low-dose CT scan. This approach aims to overcome barriers to screening by making it more accessible, especially for underserved populations. ^{4 5 11 12 13}

Research Team

Katharine Rendle, PhD

Principal Investigator

Abramson Cancer Center

Eligibility Criteria

This trial is for individuals who are potential candidates for lung cancer screening. It's not clear what specific inclusion criteria are, but typically participants would be at risk for lung cancer due to factors like age and smoking history. There's no information on exclusion criteria provided.

Inclusion Criteria

History of tobacco use indicated by either documented 20 pack-year or greater smoking history in their electronic health record (EHR) or self-report via structured survey

I am between 50 and 80 years old.

I have seen a primary care doctor at Penn Medicine within the last 3 years.

Exclusion Criteria

Participants who do not meet the inclusion criteria

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Intervention

Participants receive outreach to schedule a telehealth or in-person SDM visit

30 days

1 visit (telehealth or in-person)

Stage 2 Intervention

Non-responders receive text message reminders and possibly digital care coordination

Up to 90 days

Asynchronous text messages, optional digital care coordination

Follow-up

Participants are monitored for completion of SDM and LDCT, and lung cancer diagnoses

12 months

Treatment Details

Interventions

• Integrating Telehealth to Advance Lung Cancer Screening (Behavioural Intervention)

Trial Overview The study is testing whether different telehealth strategies can improve the rate of shared decision-making visits for lung cancer screening. It will compare high touch and low touch approaches, as well as active choice methods in a two-stage process using text reminders and digital coordination.

Participant Groups

Group I: Telehealth Only (Stage 1) + Low Touch (Stage 2) Experimental Treatment 2 Interventions

Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2).

Group II: Telehealth Only (Stage 1) + High Touch (Stage 2) Experimental Treatment 2 Interventions

Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).

Group III: Active Choice (Stage 1) + Low Touch (Stage 2) Experimental Treatment 2 Interventions

Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2)

Group IV: Active Choice (Stage 1) + High Touch (Stage 2) Experimental Treatment 2 Interventions

Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

In New York state, nearly half (48.3%) of lung cancer patients were diagnosed with late-stage disease, highlighting the need for improved access to lung cancer screening resources, especially in rural areas.

The study found that rural counties had fewer lung cancer screening centers and higher lung cancer mortality rates, indicating that geographic disparities in healthcare resources significantly impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. Somayaji, D., Seo, YS., Wilding, GE., et al.[2023]

In a study of high-risk individuals undergoing lung cancer screening via telemedicine, 20.6% did not complete their low-dose computed tomography (LDCT) scans, highlighting a significant gap in screening completion.

Factors such as being a new patient, having lower education levels, and living in areas with high socioeconomic deprivation were associated with higher odds of incomplete screening, suggesting that targeted interventions are needed to improve completion rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual- and neighborhood-level characteristics of lung cancer screening participants undergoing telemedicine shared decision making. Shusted, CS., Juon, HS., Ruane, B., et al.[2023]

The implementation of lung screening programs is crucial for early detection and treatment of lung cancer, with successful examples from the Mount Sinai Healthcare System and the Phoenix Veterans Affairs Health Care System, utilizing the Early Lung Cancer Action Program (ELCAP) Management System.

Annual lung screening is essential, especially for heavy smokers, as it significantly increases the chances of curing lung cancer, highlighting the need for continuous evaluation and adaptation of screening programs to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of low-dose CT screening in two different health care systems: Mount Sinai Healthcare System and Phoenix VA Health Care System. Henschke, CI., Yankelevitz, DF., Jirapatnakul, A., et al.[2021]

Lung cancer screening programs across four health care systems showed variability in how they confirm patient eligibility and manage follow-up care, highlighting the need for standardized approaches to improve quality of care.

Effective data collection methods, such as using electronic health records and standardized templates, are crucial for monitoring screening outcomes, but challenges like incomplete smoking histories and distinguishing screening from diagnostic scans need to be addressed to enhance the overall effectiveness of lung cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Lung Cancer Screening Use and Outcomes at Four Cancer Research Network Sites. Gould, MK., Sakoda, LC., Ritzwoller, DP., et al.[2019]

In a study of 1509 participants from diverse backgrounds, lung cancer screening with low-dose CT detected and treated cancer in 2.8% of cases, demonstrating its efficacy in early detection.

The screening had a low false-positive rate of 9.2% and resulted in very few complications, but adherence to annual screening was notably poor, with only 18.7% of participants returning for follow-up in the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. Erkmen, CP., Randhawa, S., Patterson, F., et al.[2023]

A qualitative study involving 10 primary care physicians and 30 patients revealed that while awareness and support for lung cancer screening with low-dose computed tomography (LCS-LDCT) have increased since Medicare coverage, there is still a lack of shared decision-making and use of decision aids, which are required by Medicare.

To improve the implementation of LCS-LDCT screening, the study suggests creating a simple, graphic-heavy decision aid to help address ongoing barriers and enhance communication between providers and patients, ultimately aiming to reduce lung cancer mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider and patient perspectives to improve lung cancer screening with low-dose computed tomography 5 years after Medicare coverage: a qualitative study. Martinez, MC., Stults, CD., Li, J.[2022]

In a study of 551 adults eligible for lung cancer screening (LCS) followed for an average of 2.9 years, LCS was more frequently utilized among individuals with higher lung cancer risk and lower comorbidity, indicating that screening is targeted towards those who may benefit the most.

The data showed a significant increase in LCS usage from 5 to 13 per 100 person-years as lung cancer risk increased, while usage decreased from 14 to 8 per 100 person-years with rising comorbidity, highlighting how patient health profiles influence screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of lung cancer risk and comorbidity in lung cancer screening use. Richman, IB., Long, JB., Poghosyan, H., et al.[2023]

A study analyzing data from 540,747 lung cancer patients revealed that the incidence of adverse events during lung biopsies increased significantly from 24% in 2001 to 38% in 2010, indicating a growing concern for patient safety.

Patients who experienced adverse events had longer hospital stays and a significantly higher risk of in-hospital mortality, with an adjusted odds ratio of 5.9, highlighting the need for improved safety measures in lung biopsy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. von Itzstein, MS., Gupta, A., Mara, KC., et al.[2020]

A randomized trial involving 298 Maryland Tobacco Quitline callers showed that providing lung cancer screening (LCS) education through print materials led to higher engagement (75% read the materials) compared to web-based materials (61.6%).

Despite similar rates of scheduling or completing LCS between the two groups (around 43%), the study highlights that offering educational materials in preferred formats (print or web) can enhance awareness and potentially increase screening rates among eligible individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. Webster, M., Whealan, J., Williams, RM., et al.[2023]

Lung cancer screening has been shown to improve survival rates, but many people are not participating in these screenings due to various barriers.

The authors emphasize the importance of creating a tailored and adaptable lung cancer screening program that addresses community needs, involves key stakeholders, and optimizes health systems for better patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Lung Cancer Screening Program. Chudgar, NP., Stiles, BM.[2023]

The implementation of a single-encounter telemedicine (SET) lung cancer screening during COVID-19 resulted in fewer patients being screened (440) compared to pre-COVID in-person screenings (673), particularly affecting the representation of Black/African American patients, which dropped from 52.5% to 37%.

Despite the shift to telemedicine, there was no significant difference in the Lung-RADS scores or diagnostic procedures between the two screening methods, but the telemedicine approach diagnosed fewer cancers (1.6% vs. 3.3%), indicating potential limitations in cancer detection during telemedicine screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Single - Encounter Telemedicine Lung Cancer Screening: A Retrospective Cohort Study in an Underserved Population. Magarinos, J., Lutzow, L., Dass, C., et al.[2023]

Low-dose computer tomographic (LDCT) lung cancer screening significantly reduces lung cancer-specific and overall mortality in high-risk individuals, but participation remains low at under 10% despite insurance coverage since 2015, highlighting the need for improved outreach and eligibility criteria.

To enhance the effectiveness of lung cancer screening, multilevel solutions are necessary, including better management of lung nodules detected incidentally and innovative technologies like biomarkers and artificial intelligence to improve safety and cost-effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the Reach and Grasp of Lung Cancer Screening. Osarogiagbon, RU., Yang, PC., Sequist, LV.[2023]

References

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

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

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

A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Individual- and neighborhood-level characteristics of lung cancer screening participants undergoing telemedicine shared decision making. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Implementation of low-dose CT screening in two different health care systems: Mount Sinai Healthcare System and Phoenix VA Health Care System. [2021]

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

Monitoring Lung Cancer Screening Use and Outcomes at Four Cancer Research Network Sites. [2019]

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

Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Provider and patient perspectives to improve lung cancer screening with low-dose computed tomography 5 years after Medicare coverage: a qualitative study. [2022]

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

The role of lung cancer risk and comorbidity in lung cancer screening use. [2023]

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

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. [2023]

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

Building a Lung Cancer Screening Program. [2023]

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

Feasibility of Single - Encounter Telemedicine Lung Cancer Screening: A Retrospective Cohort Study in an Underserved Population. [2023]

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

Expanding the Reach and Grasp of Lung Cancer Screening. [2023]