Recruiting

Telehealth Strategies

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06638554

Conditions

Early Detection of Cancer

Telemedicine

Decision Making

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Choice

Telehealth Only

Low Touch Strategy

High Touch Strategy

Study Details

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.

Conditions

Early Detection of Cancer

Telemedicine

Decision Making

Study ID

NCT06638554

Start date

Jul 9, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

6000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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).

Interventions

Active Choice

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

Telehealth Only

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

Low Touch Strategy

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

High Touch Strategy

Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.

Primary outcome measure

  • Shared decision making (SDM) for lung cancer screening (LCS) [ Time Frame: 90 days after randomization ]

Central Contacts and Locations

Central contacts

Katharine Rendle, PhD

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

Hannah Toneff, MSW, MA

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Katharine Rendle, PhD,MSW,MPH

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

Hannah Toneff, MSW, MA

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

Principal Investigator:

Katharine Rendle, PhD,MSW,MPH

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-05-29.