Clinical trial NCT06638554: Integrating Telehealth to Advance Lung Cancer Screening
Official title: Integrating Telehealth to Advance Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Detection of Cancer
Telemedicine
Decision Making
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-10-15
Enrollment: 6000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Primary outcomes:
measure: Shared decision making (SDM) for lung cancer screening (LCS)
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Low-dose computed tomography (LDCT)
timeFrame: 6 months after randomization
Other outcomes:
measure: Fidelity to Shared Decision-Making
timeFrame: Up to 90 days after randomization
measure: Fidelity to Digital Care Coordination
timeFrame: Up to 90 days after randomization
measure: Lung cancer diagnoses
timeFrame: 12 months after randomization
measure: Reach: Text Message Delivery
timeFrame: Up to 90 days after randomization
measure: Reach: Digital Care Coordination
timeFrame: Up to 90 days after randomization
measure: Reach: Scheduling
timeFrame: Up to 90 days after randomization
measure: Timeliness
timeFrame: Up to 12 months after randomization
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: Katharine Rendle, PhD
role: PRINCIPAL_INVESTIGATOR
References: