TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
Part of paid clinical trials in New Brunswick, New Jersey.
- Sponsor
- Rutgers, The State University of New Jersey
- Study ID
- NCT07165691
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 77 Years
- Healthy Volunteers
- Accepted
Interventions
- TELESCOPE, Remote Decision Coaching with Navigation Intervention — BEHAVIORALThe 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
Study Details
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.
Key Dates
- Start date
- Sep 11, 2025
- Status verified
- Nov 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 91 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SCREENING
Arms
- Experimental: TELESCOPE interventionParticipants 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 CareParticipants 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.
Primary Outcome Measure
Recruitment rate [ Time Frame: 1 week post-intervention ]
Central Contacts
- Evelyn Arana, DrPH9086420861
- Arlette Chavez-Iniguez, MD(732)715-4923
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08901 | Evelyn Arana, DrPH (PRINCIPAL_INVESTIGATOR) |
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