Telehealth Strategies for Lung Cancer Screening

(ITALCS Trial)

Overseen By Anil Vachani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Lung cancer, Recent screening, others

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

Compensation: Varies

Number of Visits: 1

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how telehealth can improve lung cancer screening, with a focus on shared decision-making between patients and doctors. The research aims to determine if various telehealth methods can increase screening participation and whether these methods are equally effective across different races and sexes. Participants will receive outreach to schedule a telehealth or in-person visit, with follow-ups for those who do not initially respond. Suitable candidates have a history of smoking, no lung cancer, and have not been screened for lung cancer in the past two years. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance lung cancer screening for diverse populations.

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 these telehealth strategies are safe for lung cancer screening?

Research has shown that telehealth provides a safe and effective method for lung cancer screening. Studies indicate that telehealth visits match in-person visits in quality for discussing lung cancer screening. This means telehealth does not lead to more problems or side effects than traditional doctor visits.

One study found that during the early days of COVID-19, telehealth was frequently used to make screening recommendations, suggesting it is a trusted method and that people felt comfortable using it. Telehealth also enhances access to healthcare and improves communication between patients and doctors, potentially leading to better health outcomes.

Overall, evidence shows that telehealth is well-tolerated, with no major safety issues reported. Participants considering a trial with telehealth components can feel confident about the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telehealth strategies for lung cancer screening because they offer a more flexible and accessible way for patients to engage in shared decision-making (SDM) visits. Unlike traditional in-person appointments, these strategies utilize telehealth consultations, allowing patients to discuss their screening options from the comfort of their own homes. Additionally, the trial is exploring different levels of follow-up engagement, using asynchronous text messages and digital care coordination, to ensure patients receive the support they need to complete the screening process. This approach could potentially increase screening rates and early detection, making lung cancer care more efficient and patient-centered.

What evidence suggests that this trial's telehealth strategies could be effective for increasing shared decision-making in lung cancer screening?

This trial will compare different telehealth strategies for lung cancer screening. Studies have shown that telehealth is as effective as in-person visits for lung cancer screening consultations. Research indicates that technology, like telehealth, encourages people to get screened for lung cancer and aids in decision-making with their doctors. A review of studies found that these technology-based methods support lung cancer patients during treatment. This suggests that telehealth could be a useful and effective way to conduct lung cancer screenings. Overall, telehealth might help more people complete their screening visits, regardless of race or gender. Participants in this trial will be assigned to different arms, such as "Telehealth Only" or "Active Choice," to evaluate the effectiveness of these approaches. ^{1 2 6 7 8}

Who Is on the Research Team?

Katharine Rendle, PhD

Principal Investigator

Abramson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Integrating Telehealth to Advance Lung Cancer Screening

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12150070/

Association of Telehealth Encounters With Lung Cancer ...

This study suggests that telehealth and in-person encounters seem to be comparable for lung cancer screening consultations.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06638554

Integrating Telehealth to Advance Lung Cancer Screening

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening ...

3.

nature.com

nature.com/articles/s41746-025-01913-7

Systematic review on the technology's role in supporting ...

This systematic review examines the role of technology-based interventions in supporting lung cancer patients during their treatment.

4.

mdpi.com

mdpi.com/1660-4601/22/8/1250

Effectiveness of Technology-Based Interventions in ...

This study reviews how technology-based interventions have been designed and implemented to promote lung cancer screening (LCS), support shared ...

5.

ascopubs.org

ascopubs.org/doi/pdf/10.1200/CCI.24.00086

Virtual Health Care Encounters for Lung Cancer Screening ...

Future initiatives examining both patient and clinician perceptions, uptake, and effectiveness of telehealth in underserved communities may help ...

6.

bmcprimcare.biomedcentral.com

bmcprimcare.biomedcentral.com/articles/10.1186/s12875-024-02610-2

a study protocol for delivering shared decision-making for lung ...

This protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators.

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2819704

Lung Cancer Screening Before and After a Multifaceted ...

This study found that a multifaceted electronic health record–integrated intervention was associated with increased care gap closure for lung cancer screening.

8.

healthcaredelivery.cancer.gov

healthcaredelivery.cancer.gov/telehealth/trace.html

NCI Telehealth Research Centers of Excellence (TRACE)

Research has shown that telehealth can improve healthcare access and quality, patient/provider communication, and health outcomes. Importantly, ...