About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
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
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
The investigators expect a recruitment rate of ≥60%.
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.
Follow-up completion rate
The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Intervention Fidelity Rate
The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.
Secondary outcomes
Rate of participants that have completed LDCT
The investigators will assess the rates of completion of LDCT at 3 months post-intervention for all participants. This will be abstracted from patients' medical records.
To assess shared decision making quality
This will be assessed with the Shared Decision-Making Process Survey (SDM Process\_4), which is a 4-item performance measure of the process and outcome of shared decision making. Scores range from 0 to 4, with higher scores indicating a better process.
Feasibility of intervention (Clinicians)
The feasibility of the intervention (FIM) measure will be completed by clinicians. The total score for this instrument ranges from 4 to 20, with higher scores indicating greater feasibility.
Clinicians Acceptability
The acceptability of the intervention (AIM) will be completed by clinicians. The total score ranges from 4 to 20, with higher scores indicating greater acceptability.
Other outcomes
Tobacco treatment referral
Medical records will be reviewed at 3 months post-intervention to determine if a tobacco treatment referral has been generated.
Receipt of tobacco treatment
Medical records will be reviewed at 3 months post-intervention to determine if the patient has undergone tobacco treatment.
Cancer Fatalism
The investigators will assess cancer fatalism by asking participants to rate how much they agree or disagree with 3 items: 1) It seems like everything causes cancer, 2) There's not much participants can do to lower their chances of getting cancer, and 3) There are so many recommendations about preventing cancer, it's hard to know which ones to follow. Response categories for each item are on a four-point scale ranging from strongly agree to strongly disagree. There is no total score for this survey. Responses will be reported descriptively for each question. This measure has shown good internal consistency (Cronbach's alpha = 0.60).
Decisional Conflict
The Decisional Conflict Scale is a widely used measure of the degree to which a patient feels clear about the options and sure about the choice they make. The scale is scored from 0 to 100, with scores under 25 being associated with implementing decisions, while scores above 37.5 suggest delays in decision making.
Sponsors and contacts
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Rutgers, The State University of New Jersey
Lead sponsor
New Jersey Commission on Cancer Research
Collaborator