RecruitingRecruiting
Integrating Telehealth to Advance Lung Cancer Screening
NCT06638554 · Abramson Cancer Center at Penn Medicine
In plain English
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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.
Eligibility criteria
Inclusion criteria:
Participants will be eligible if:
1. are aged 50 to 80
2. 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
3. currently smoke or formerly smoked cigarettes
4. have no documented history of lung cancer
5. have no documented history of lung cancer screening in the 24 months prior to study enrollment
6. 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.
Study design
Enrollment target: 6000 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-07-09
Estimated completion: 2027-06-30
Last updated: 2026-05-29
Interventions
Behavioral: Active ChoiceBehavioral: Telehealth OnlyBehavioral: Low Touch StrategyBehavioral: High Touch Strategy
Primary outcomes
- • Shared decision making (SDM) for lung cancer screening (LCS) (90 days after randomization)
Sponsor
Abramson Cancer Center at Penn Medicine · other
With: National Institutes of Health (NIH), National Cancer Institute (NCI)
Contacts & investigators
ContactKatharine Rendle, PhD · contact · katharine.rendle@pennmedicine.upenn.edu · 215-349-5442
ContactHannah Toneff, MSW, MA · contact · Hannah.Toneff@pennmedicine.upenn.edu · 267-882-3186
InvestigatorKatharine Rendle, PhD · principal_investigator, Abramson Cancer Center
All locations (1)
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States