Recruiting

Telehealth Coaching

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05491213

Conditions

Lung Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TELESCOPE, Remote Decision Coaching with Navigation Intervention

Study Details

Brief summary:

Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.

Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.

Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).

Conditions

Lung Neoplasms

Study ID

NCT05491213

Start date

Feb 14, 2023

Status verified date

Dec, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

\- Inclusion Criteria Cluster Randomized Trial

Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:

  • Be 50 to 77 years of age
  • Be a current or former smoker having quit within the past 15 years
  • Have at least a 20 pack-year smoking history
  • Be scheduled for a non-acute care visit at one of the study sites. Interviews (N=50)

Participants completing the semi-structured interviews will be:

  • A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3)
  • Age 18 or older
  • Fluent in English Online surveys (N=130)

Providers completing online PRISM construct surveys will be:

  • A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator
  • Age 18 or older
  • Fluent in English

Exclusion Criteria:

\- Cluster Randomized Trial

Excluded will be patients who:

  • Do not speak English
  • Have a history lung cancer
  • Were screened for lung cancer within the past 12 months
  • Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider
  • Are unable to provide informed consent Interviews (N=50)

Providers/administrators will be excluded if they:

  • Are unable to provide informed consent Online surveys (N=130)
  • Are unable to provide informed consent
  • Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.

Study Design

Enrollment

594 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: TELESCOPE intervention

Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators.

no intervention: Enhanced usual care (EUC)

Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected.

Interventions

TELESCOPE, Remote Decision Coaching with Navigation Intervention

The TELESCOPE intervention involves three complementary components: 1) decision aid and coaching for LCS, 2) referral of current smokers to evidence-based smoking cessation services, and 3) for participants interested in screening, navigation to complete LCS and diagnostic testing and oncology care as needed

Primary outcome measure

  • To assess shared decision making [ Time Frame: The change in baseline, three months and five years ]

Central Contacts and Locations

Central contacts

Julie E Chapman-Greene, PhD, MPH

732-865-3375chapmaje@cinj.rutgers.edu

Rebecca Ayala

732-258-6982raa191@cinj.rutgers.edu

Locations

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Julie E Chapman-Greene, PhD, MPH

732-865-3375chapmaje@cinj.rutgers.edu

Rebecca Ayala

732-258-6982raa191@cinj.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • Lung cancer screening
  • Shared decision making

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-09.