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NCT Number: 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 (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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Anil Vachani, MD

PRINCIPAL_INVESTIGATOR

Hannah Toneff, MSW, MA

CONTACT

[email protected]

267-882-3186

Katharine Rendle, PhD,MSW,MPH

CONTACT

[email protected]

215-349- 5442

Katharine Rendle, PhD,MSW,MPH

PRINCIPAL_INVESTIGATOR

About this study

Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will be eligible if:

  • are aged 50 to 80
  • have a 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
  • currently smoke or formerly smoked cigarettes
  • have no documented history of lung cancer
  • have no documented history of lung cancer screening in the 24 months prior to study enrollment
  • have completed at least one primary care visit at Penn Medicine in the 3 years prior to study enrollment.

Exclusion criteria

Participants who do not meet inclusion criteria will not be eligible.

Treatment and study plan

Active choice

Behavioral

The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.

Telehealth Only

Behavioral

The participant will be send a letter inviting them to complete a SDM visit via telehealth only.

Low Touch Strategy

Behavioral

Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.

High Touch Strategy

Behavioral

Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.

Primary outcomes

  1. Shared decision making (SDM) for lung cancer screening (LCS)

    Time frame: 90 days after randomization

    Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.

Secondary outcomes

  1. Low-dose computed tomography (LDCT)

    Time frame: 6 months after randomization

    Completion of LDCT within 6 months of randomization date among individuals who complete SDM and are determined to be eligible for LCS.

Other outcomes

  1. Fidelity to Shared Decision-Making

    Time frame: Up to 90 days after randomization

    Completion of key components of SDM for LCS including:

    • discussion of risks & benefits of LCS
    • use of decision aid
    • elicitation of patient preferences
    • tobacco cessation support
  2. Fidelity to Digital Care Coordination

    Time frame: Up to 90 days after randomization

    Completion of key components of digital care coordination including assessing digital needs and readiness, providing technological support, answering questions about security or safety, and helping to coordinate telehealth appointments.

  3. Lung cancer diagnoses

    Time frame: 12 months after randomization

    Number of people diagnosed with lung cancer after randomization.

  4. Reach: Text Message Delivery

    Time frame: Up to 90 days after randomization

    The number of participants who are successfully delivered text messages divided by those who are sent text messages in Stage 2.

  5. Reach: Digital Care Coordination

    Time frame: Up to 90 days after randomization

    The number of participants who complete a digital care coordination visit divided by those contacted by the Digital Care Coordinator in Stage 2.

  6. Reach: Scheduling

    Time frame: Up to 90 days after randomization

    The number of participants who schedule an SDM visit divided by those who are sent initial outreach.

  7. Timeliness

    Time frame: Up to 12 months after randomization

    The number of days between randomization and SDM completion among subjects who complete SDM for LCS.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Toneff, MSW, MA

CONTACT

[email protected]

267-882-3186

Katharine Rendle, PhD

CONTACT

[email protected]

215-349-5442

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Acronym: ITALCS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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