TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics

Обзор

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.

Подробное описание

This pilot feasibility trial aims to culturally adapt an existing TELESCOPE (R01HL158850) intervention to create a culturally appropriate SDM and navigation intervention for Hispanics in primary care settings. The investigators will assess its feasibility and acceptability (primary outcomes), and explore its impact on the uptake of LDCT (secondary outcome) compared to enhanced usual care (training clinicians to discuss LCS) for LCS in Hispanics.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (5)

• Rate of participants that have completed LDCT [Срок оценки: 3 months post-intervention]
• To assess shared decision making quality [Срок оценки: 1 week post-intervention]
• Feasibility of intervention (Clinicians) [Срок оценки: 12 months post-intervention]
• Clinicians Acceptability [Срок оценки: 12 months post-intervention]
• Intervention Appropriateness (Clinicians) [Срок оценки: Post-intervention]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Rutgers Cancer Institute — New Brunswick

Идентификаторы

NCT: NCT07165691 · Pro2025001472

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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