Recruiting

TELESCOPE Intervention

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07165691

Conditions

Lung Neoplasms

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

TELESCOPE, Remote Decision Coaching with Navigation Intervention

Study Details

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

Study ID

NCT07165691

Start date

Sep 11, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

91 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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

Primary outcome measure

  • Recruitment rate [ Time Frame: 1 week post-intervention ]
  • Participant Acceptability [ Time Frame: 1 week post-intervention ]
  • Follow-up completion rate [ Time Frame: 1 week post-intervention ]
  • Intervention Fidelity Rate [ Time Frame: 1 week post-intervention ]

Central Contacts and Locations

Central contacts

Evelyn Arana, DrPH

9086420861earana@cinj.rutgers.edu

Arlette Chavez-Iniguez, MD

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

Locations

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Evelyn Arana, DrPH

908-642-0861earana@cinj.rutgers.edu

Principal Investigator:

Evelyn Arana, DrPH

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-02.