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NCT Number: NCT05491213

TELESCOPE- TELEhealth Shared Decision-making COaching

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institute, New Brunswick, New Jersey, United States

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About this study

The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening.

Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TELESCOPE, Remote Decision Coaching with Navigation Intervention

Behavioral

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 outcomes

  1. To assess shared decision making

    Time frame: The change in baseline, three months and five years

    Semi-structured interviews (qualitative data)

Secondary outcomes

  1. Tobacco treatment referral

    Time frame: The change in baseline, three months and five years

    Semi-structured interviews (qualitative data)

  2. Uptake of Low-Dose CT Screening for Lung Cancer

    Time frame: Within 6 months post-intervention

    Proportion of participants who complete low-dose CT (LDCT) lung cancer screening within 6 months post-intervention.

Other outcomes

  1. Receipt of tobacco treatment

    Time frame: The change in baseline, three months and five years

    Semi-structured interviews (qualitative data).

  2. Completion of diagnostic testing

    Time frame: The change in baseline, three months and five years

    Semi-structured interviews (qualitative data).

Study contacts

Contact information is provided by the study sponsor or research team.

Julie E Chapman-Greene, PhD, MPH

CONTACT

[email protected]

732-865-3375

Rebecca Ayala

CONTACT

[email protected]

732-258-6982

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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