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

NCT ID: NCT07165691Sponsor: Rutgers, The State University of New JerseyLast updated: 2025-12-02

Summary

Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer. Aim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable. Aim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.

Detailed description

This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.

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

  • Recruitment rate

    The investigators expect a recruitment rate of ≥60%.

    Time frame: 1 week post-intervention

  • Participant Acceptability

    The Ottawa Acceptability Measure will assess the acceptability of the TELESCOPE intervention from the patient's perspective at 1-week post-intervention. There is no total score for this measure. Responses will be reported descriptively in terms of proportions responding positively or negatively for each criteria.

    Time frame: 1 week post-intervention

  • Follow-up completion rate

    The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments

    Time frame: 1 week post-intervention

  • Intervention Fidelity Rate

    The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.

    Time frame: 1 week post-intervention

Secondary

  • Rate of participants that have completed LDCT

    Time frame: 3 months post-intervention

  • To assess shared decision making quality

    Time frame: 1 week post-intervention

  • Feasibility of intervention (Clinicians)

    Time frame: 12 months post-intervention

  • Clinicians Acceptability

    Time frame: 12 months post-intervention

  • Intervention Appropriateness (Clinicians)

    Time frame: Post-intervention

Eligibility criteria

Sex: AllAge: 50 Years to 77 YearsHealthy volunteers: Yes
Inclusion Criteria: Aim 1 (Cultural Adaptation): To be eligible, patients must: 1. Identify as Hispanic and/or Latino(a) 2. Able to read and speak in English or Spanish 3. Be 50 to 77 years of age 4. Be a current or former smoker 5. Have at least a 20-pack-year smoking history Aims 2-3 (Pilot Randomized Controlled Trial) To be eligible, patients must: * Identify as Hispanic or Latino(a) * Able to speak and read in English or Spanish * 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. * Not coughing up blood in the last two weeks Interviews Providers completing the semi-structured interviews will be: * A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator * Age 18 or older * Fluent in English Online surveys 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: For the cluster randomized trial, excluded will be patients who: * Do not speak English * Are not Hispanic or Latino(a) * Have a history of lung cancer * Had a CT scan in the past 12 months * Has been coughing up blood in the last two weeks * 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 Providers/administrators will be excluded if they: * Are unable to provide informed consent Online surveys * Are unable to provide informed consent * Women who are pregnant.

Study locations (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901

Recruiting
Evelyn Arana, DrPH · Contact
908-642-0861earana@cinj.rutgers.edu
Evelyn Arana, DrPH · Principal Investigator