NCT07165691 · Rutgers, The State University of New Jersey
TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
(TELESCOPE-H)
What this study is 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.
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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.
Interventions
BEHAVIORAL
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 measures
Recruitment rate
Time frame: 1 week post-intervention
The investigators expect a recruitment rate of ≥60%.
Participant Acceptability
Time frame: 1 week post-intervention
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.
Follow-up completion rate
Time frame: 1 week post-intervention
The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Intervention Fidelity Rate
Time frame: 1 week post-intervention
The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Where
- New Brunswick, New Jersey
Collaborators
New Jersey Commission on Cancer Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 2, 2025 · Source of record for eligibility and locations