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

NCT ID: NCT07165691

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2027-06-30

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.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

TELESCOPE intervention

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.

Group Type: EXPERIMENTAL

TELESCOPE, Remote Decision Coaching with Navigation Intervention

Intervention Type: BEHAVIORAL

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

Enhanced Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TELESCOPE, 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Jersey Commission on Cancer Research

UNKNOWN

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Evelyn Arana, DrPH

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evelyn Arana, DrPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of NJ

Locations

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evelyn Arana, DrPH

Role: CONTACT

earana@cinj.rutgers.edu

9086420861

Arlette Chavez-Iniguez, MD

Role: CONTACT

ac2758@CINJ.Rutgers.edu

(732)715-4923

Facility Contacts

Evelyn Arana, DrPH

Role: primary

earana@cinj.rutgers.edu

908-642-0861

Other Identifiers

Pro2025001472

Identifier Type: -

Identifier Source: org_study_id