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TELESCOPE- TELEhealth Shared Decision-making COaching

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05491213
Enrollment
594
Registered
2022-08-08
Start date
2023-02-14
Completion date
2027-01-31
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Lung cancer screening, Shared decision making

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).

Detailed 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.

Interventions

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Quantitative measures of the PRISM constructs will be collected via internet surveys from the patient and nurse navigators, clinic directors, and clinicians (n = 130 surveys), and through medical record review. Participants followed at the TELESCOPE arm sites will also complete a measure of intervention acceptability at the one week survey for Aim 2. Semi-structured interviews will be conducted for Aim 2 with a mix of 20 clinical, nursing, and administrative directors at the participating sites. All 10 study navigators, and 20 clinicians from the TELESCOPE arm sites will also be interviewed.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To assess shared decision makingThe change in baseline, three months and five yearsSemi-structured interviews (qualitative data)

Secondary

MeasureTime frameDescription
Tobacco treatment referralThe change in baseline, three months and five yearsSemi-structured interviews (qualitative data)
Uptake of Low-Dose CT Screening for Lung CancerWithin 6 months post-interventionProportion of participants who complete low-dose CT (LDCT) lung cancer screening within 6 months post-intervention.

Other

MeasureTime frameDescription
Receipt of tobacco treatmentThe change in baseline, three months and five yearsSemi-structured interviews (qualitative data).
Completion of diagnostic testingThe change in baseline, three months and five yearsSemi-structured interviews (qualitative data).

Countries

United States

Contacts

Primary ContactJulie E Chapman-Greene, PhD, MPH
chapmaje@cinj.rutgers.edu732-865-3375
Backup ContactRebecca Ayala
raa191@cinj.rutgers.edu732-258-6982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026