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Integrating Telehealth to Advance Lung Cancer Screening

ConditionsEarly Detection of CancerTelemedicineDecision Making
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAbramson Cancer Center at Penn Medicine

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

6,000 Participants
are divided into 4 treatment groups
Group A: Active Choice (Stage 1) + Low Touch (Stage 2)Experimental treatment 2 interventions
Group B: Active Choice (Stage 1) + High Touch (Stage 2)Experimental treatment 2 interventions
Group C: Telehealth Only (Stage 1) + Low Touch (Stage 2)Experimental treatment 2 interventions
Group D: Telehealth Only (Stage 1) + High Touch (Stage 2)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
90 days after randomization

Secondary outcomes

1

Low-dose computed tomography (LDCT)

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

Time frame
6 months after randomization

Other outcomes

1

Fidelity to Shared Decision-Making

Completion of key components of SDM for LCS including: 1. discussion of risks \& benefits of LCS 2. use of decision aid 3. elicitation of patient preferences 4. tobacco cessation support

Time frame
Up to 90 days after randomization
2

Fidelity to Digital Care Coordination

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.

Time frame
Up to 90 days after randomization
3

Lung cancer diagnoses

Number of people diagnosed with lung cancer after randomization.

Time frame
12 months after randomization
4

Reach: Text Message Delivery

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

Time frame
Up to 90 days after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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