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

Rutgers The State University of New Jersey

Status: Begins enrollment in 11 months

Conditions: Lung Neoplasms

Treatments: Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07165691

Pro2025001472

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 50 to 77 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

TELESCOPE intervention

Experimental group

Description:

Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. If a participant is a current smoker then they are offered and navigated to evidence-based smoking cessation. If the participant is interested in screening, an LDCT is ordered. Support for screening, diagnostic testing and oncology care will be provided as needed from the Nurse Navigators.

Treatment:

Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

Enhanced Usual Care

No Intervention group

Description:

Participants will be surveyed at baseline and at one-week after the scheduled primary care office visit. Primary and secondary outcome data related to the office visit will be collected.