An interventional study of Active Choice and Telehealth Only in Early Detection of Cancer, Telemedicine and Decision Making, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research
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:
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.
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.
Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be eligible if:
Exclusion criteria:
Participants who do not meet inclusion criteria will not be eligible.
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)
Behavioral: Active Choice · Behavioral: Low Touch Strategy
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).
Behavioral: Active Choice · Behavioral: High Touch Strategy
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).
Behavioral: Telehealth Only · Behavioral: Low Touch Strategy
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).
Behavioral: Telehealth Only · Behavioral: High Touch Strategy
The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.
The participant will be send a letter inviting them to complete a SDM visit via telehealth only.
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.
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
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
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
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
Lung cancer diagnoses
Number of people diagnosed with lung cancer after randomization.
Time frame: 12 months after randomization
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
Reach: Digital Care Coordination
The number of participants who complete a digital care coordination visit divided by those contacted by the Digital Care Coordinator in Stage 2.
Time frame: Up to 90 days after randomization
Reach: Scheduling
The number of participants who schedule an SDM visit divided by those who are sent initial outreach.
Time frame: Up to 90 days after randomization
Timeliness
The number of days between randomization and SDM completion among subjects who complete SDM for LCS.
Time frame: Up to 12 months after randomization
Plan to share: No
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Abramson Cancer Center at Penn Medicine