Integrating Telehealth to Advance Lung Cancer Screening

NCT06638554 | Recruiting

• 3 other identifiers: UPCC 04524P50CA271338850376
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

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. 1.Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
2. 2.Is the effectiveness of these telehealth strategies similar by race and sex?

Conditions

Early Detection of Cancer; Telemedicine; Decision Making

Outcome Measures

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.

  90 days after randomization

Secondary Outcomes (1)

• Low-dose computed tomography (LDCT)

  6 months after randomization

Other Outcomes (7)

• Fidelity to Shared Decision-Making

  Up to 90 days after randomization

• Fidelity to Digital Care Coordination

  Up to 90 days after randomization

• Lung cancer diagnoses

  12 months after randomization

Study Arms (4)

Active Choice (Stage 1) + Low Touch (Stage 2)

EXPERIMENTAL

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

Active Choice (Stage 1) + High Touch (Stage 2)

EXPERIMENTAL

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

Telehealth Only (Stage 1) + Low Touch (Stage 2)

EXPERIMENTAL

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

Telehealth Only (Stage 1) + High Touch (Stage 2)

EXPERIMENTAL

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

Interventions

Active Choice BEHAVIORAL

The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.

Active Choice (Stage 1) + High Touch (Stage 2); Active Choice (Stage 1) + Low Touch (Stage 2)

Telehealth Only BEHAVIORAL

The participant will be send a letter inviting them to complete a SDM visit via telehealth only.

Telehealth Only (Stage 1) + High Touch (Stage 2); Telehealth Only (Stage 1) + Low Touch (Stage 2)

Low Touch Strategy BEHAVIORAL

Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.

Active Choice (Stage 1) + Low Touch (Stage 2); Telehealth Only (Stage 1) + Low Touch (Stage 2)

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.

Active Choice (Stage 1) + High Touch (Stage 2); Telehealth Only (Stage 1) + High Touch (Stage 2)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Katharine Rendle, PhD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Rendle, PhD

CONTACT

215-349-5442; katharine.rendle@pennmedicine.upenn.edu

Hannah Toneff, MSW, MA

CONTACT

267-882-3186; Hannah.Toneff@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)