TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
Recruiting · NCT07165691 · Interventional (participants receive a specific treatment) · Lead sponsor: Rutgers, The State University of New Jersey
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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
- nline 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 it is running
1 location listed across 1 US state.
- Rutgers Cancer Institute - New Brunswick, New Jersey, United States