Integrating Telehealth to Advance Lung Cancer Screening

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Katharine Rendle, PhD
katharine.rendle@pennmedicine.upenn.edu
215-349-5442
Backup
Hannah Toneff, MSW, MA
Hannah.Toneff@pennmedicine.upenn.edu
267-882-3186
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 6000
Treatments
Experimental: Active Choice (Stage 1) + Low Touch (Stage 2)
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)
Experimental: Active Choice (Stage 1) + High Touch (Stage 2)
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).
Experimental: Telehealth Only (Stage 1) + Low Touch (Stage 2)
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).
Experimental: Telehealth Only (Stage 1) + High Touch (Stage 2)
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).
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov