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

Not Applicable

Not yet recruiting

• Conditions: Lung Neoplasms

• Registration Number: NCT07165691
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Study Start: 2026-09-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

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)

Patients:

• 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.

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	1 week post-intervention	The investigators expect a recruitment rate of ≥60%.
Participant Acceptability	1 week post-intervention	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.
Follow-up completion rate	1 week post-intervention	The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Intervention Fidelity Rate	1 week post-intervention	The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.

Secondary Outcome Measures

Name	Time	Method
Rate of participants that have completed LDCT	3 months post-intervention	The investigators will assess the rates of completion of LDCT at 3 months post-intervention for all participants. This will be abstracted from patients' medical records.
To assess shared decision making quality	1 week post-intervention	This will be assessed with the Shared Decision-Making Process Survey (SDM Process\_4), which is a 4-item performance measure of the process and outcome of shared decision making. Scores range from 0 to 4, with higher scores indicating a better process.
Feasibility of intervention (Clinicians)	12 months post-intervention	The feasibility of the intervention (FIM) measure will be completed by clinicians. The total score for this instrument ranges from 4 to 20, with higher scores indicating greater feasibility.
Clinicians Acceptability	12 months post-intervention	The acceptability of the intervention (AIM) will be completed by clinicians. The total score ranges from 4 to 20, with higher scores indicating greater acceptability.
Intervention Appropriateness (Clinicians)	Post-intervention	The Intervention Appropriateness Measure (IAM) will be completed by clinicians. The total score for each instrument ranges from 4 to 20, with higher scores indicating greater acceptability.

Trial Locations

Locations (1)

Rutgers Cancer Institute; 🇺🇸 New Brunswick, New Jersey, United States