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

NCT07165691 | Recruiting

• 1 other identifier: Pro2025001472
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

lung cancer screening; shared decision making; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  The investigators expect a recruitment rate of ≥60%.

  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.

  1 week post-intervention

• Follow-up completion rate

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

  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.

  1 week post-intervention

Secondary Outcomes (5)

• Rate of participants that have completed LDCT

  3 months post-intervention

• To assess shared decision making quality

  1 week post-intervention

• Feasibility of intervention (Clinicians)

  12 months post-intervention

• Clinicians Acceptability

  12 months post-intervention

• Intervention Appropriateness (Clinicians)

  Post-intervention

Other Outcomes (6)

• Tobacco treatment referral

  3 months post-intervention

• Receipt of tobacco treatment

  3 months post-intervention

• Cancer Fatalism

  Baseline and 1-week post-intervention

Study Arms (2)

TELESCOPE intervention

EXPERIMENTAL

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.

Behavioral: TELESCOPE, Remote Decision Coaching with Navigation Intervention

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

TELESCOPE, Remote Decision Coaching with Navigation Intervention 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

TELESCOPE intervention

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1 (Cultural Adaptation):
• To be eligible, patients must:
• Identify as Hispanic and/or Latino(a)
• Able to read and speak in English or Spanish
• Be 50 to 77 years of age
• Be a current or former smoker
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• New Jersey Commission on Cancer Research: collaborator

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Interventions

Telescopes

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Officials

• Evelyn Arana, DrPH

  Rutgers Cancer Institute of NJ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Arana, DrPH

CONTACT

9086420861; earana@cinj.rutgers.edu

Arlette Chavez-Iniguez, MD

CONTACT

(732)715-4923; ac2758@CINJ.Rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will conduct three focus groups and interviews to culturally adapt the intervention materials for a heterogeneous Hispanic population (Aim 1). After the intervention is culturally adapted, clinicians serving large numbers of Hispanic patients will be the unit of randomization (Aims 2-3). The investigators will randomize 1:1 clinicians to the culturally adapted intervention (TELESCOPE) versus enhanced usual care (EUC). Patients of clinicians will all be assigned to the arm to which the clinician was assigned.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)