NCT05491213 TELESCOPE- TELEhealth Shared Decision-making COaching
| NCT ID | NCT05491213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Lung Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 594 participants |
| Start Date | 2023-02-14 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 594 participants in total. It began in 2023-02-14 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Anita Y Kinney, PhD, RN
PRINCIPAL INVESTIGATOR
Rutgers Cancer Institute
Frequently Asked Questions
Who can join the NCT05491213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05491213 currently recruiting?
Yes, NCT05491213 is actively recruiting participants. Contact the research team at chapmaje@cinj.rutgers.edu for enrollment information.
Where is the NCT05491213 trial being conducted?
This trial is being conducted at New Brunswick, United States, Houston, United States.
Who is sponsoring the NCT05491213 clinical trial?
NCT05491213 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Anita Y Kinney, PhD, RN at Rutgers Cancer Institute. The trial plans to enroll 594 participants.