Integrating Telehealth to Advance Lung Cancer Screening

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06638554
Status
Recruiting
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Conditions

  • Decision Making
  • Early Detection of Cancer
  • Telemedicine

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Choice — BEHAVIORAL
    The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.
  • Telehealth Only — BEHAVIORAL
    The participant will be send a letter inviting them to complete a SDM visit via telehealth only.
  • Low Touch Strategy — BEHAVIORAL
    Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 9, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
6,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Katharine Rendle, PhD,MSW,MPH
[email protected]
215-349- 5442
Hannah Toneff, MSW, MA
[email protected]
267-882-3186
Katharine Rendle, PhD,MSW,MPH (PRINCIPAL_INVESTIGATOR)
Anil Vachani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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