RecruitingInterventional

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

NCT ID: NCT05491213Sponsor: Rutgers, The State University of New JerseyLast updated: 2025-12-09

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.

Arms & interventions

BehavioralTELESCOPE, 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

Outcome measures

Primary

To assess shared decision making
Semi-structured interviews (qualitative data)
Time frame: The change in baseline, three months and five years

Secondary

Tobacco treatment referral
Time frame: The change in baseline, three months and five years
Uptake of Low-Dose CT Screening for Lung Cancer
Time frame: Within 6 months post-intervention

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (2)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901

Recruiting

Julie E Chapman-Greene, PhD, MPH · Contact

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

Rebecca Ayala · Contact

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

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Active Not Recruiting

References

Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. BMC Prim Care. 2024 Oct 18;25(1):373. doi: 10.1186/s12875-024-02610-2.(PubMed)
Tan NQP, Lowenstein LM, Douglas EE, Silva J, Bershad JM, An J, Shete SS, Steinberg MB, Ferrante JM, Clark EC, Natale-Pereira A, Sahu NN, Hastings SE, Hoffman RM, Volk RJ, Kinney AY. The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators. Res Sq [Preprint]. 2024 Apr 22:rs.3.rs-4254047. doi: 10.21203/rs.3.rs-4254047/v1.(PubMed)