6000 Participants Needed

Telehealth Strategies for Lung Cancer Screening

(ITALCS Trial)

HT
KR
AV
Overseen ByAnil Vachani, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 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.12345

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.678910

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.45111213

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.

Research Team

KR

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.
See 3 more

Exclusion Criteria

Participants who do not meet the inclusion criteria

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
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
4Treatment groups
Experimental Treatment
Group I: Telehealth Only (Stage 1) + Low Touch (Stage 2)Experimental Treatment2 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 Treatment2 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 Treatment2 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 Treatment2 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).

Find a Clinic Near You

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+

Findings from Research

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.
Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening.Wernli, KJ., Tuzzio, L., Brush, S., et al.[2022]
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.
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.
Individual- and neighborhood-level characteristics of lung cancer screening participants undergoing telemedicine shared decision making.Shusted, CS., Juon, HS., Ruane, B., et al.[2023]

References

Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening. [2022]
A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. [2023]
Individual- and neighborhood-level characteristics of lung cancer screening participants undergoing telemedicine shared decision making. [2023]
Implementation of low-dose CT screening in two different health care systems: Mount Sinai Healthcare System and Phoenix VA Health Care System. [2021]
Monitoring Lung Cancer Screening Use and Outcomes at Four Cancer Research Network Sites. [2019]
Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. [2023]
Provider and patient perspectives to improve lung cancer screening with low-dose computed tomography 5 years after Medicare coverage: a qualitative study. [2022]
The role of lung cancer risk and comorbidity in lung cancer screening use. [2023]
Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. [2020]
The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Building a Lung Cancer Screening Program. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Feasibility of Single - Encounter Telemedicine Lung Cancer Screening: A Retrospective Cohort Study in an Underserved Population. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Expanding the Reach and Grasp of Lung Cancer Screening. [2023]
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