Lung Cancer Clinical Trial

TELESCOPE- TELEhealth Shared Decision-making COaching

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).

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

- Inclusion Criteria Cluster Randomized Trial (N=420)

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=47)

Participants completing the semi-structured interviews will be:

A practicing primary care provider or a clinic director, nursing director, or clinic administrative director (n=40) at one of the participating sites or a TELESCOPE study access navigator (n=5) and nurse navigator (n = 2)
Age 18 or older
Fluent in English Online surveys (N=127)

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 (N=420)

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=47)

Providers/administrators will be excluded if they:

Are unable to provide informed consent Online surveys (N=127)
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 is for people with:

Lung Cancer

Estimated Enrollment:

420

Study ID:

NCT05491213

Recruitment Status:

Not yet recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There is 1 Location for this study

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Rutgers, Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States More Info
Anita Kinney, PhD
Contact
732-235-8871
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

420

Study ID:

NCT05491213

Recruitment Status:

Not yet recruiting

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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