TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
TELESCOPE intervention
Participants 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.
干预措施: TELESCOPE, Remote Decision Coaching with Navigation Intervention (Behavioral)
Enhanced Usual Care
Participants 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.
结局指标
主要结局
Recruitment rate
时间窗: 1 week post-intervention
The investigators expect a recruitment rate of ≥60%.
Participant Acceptability
时间窗: 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
时间窗: 1 week post-intervention
The investigators expect that ≥90% of Hispanic participants will complete the 1-week follow-up assessments
Intervention Fidelity Rate
时间窗: 1 week post-intervention
The investigators expect that ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators.
次要结局
- Rate of participants that have completed LDCT(3 months post-intervention)
- To assess shared decision making quality(1 week post-intervention)
- Feasibility of intervention (Clinicians)(12 months post-intervention)
- Clinicians Acceptability(12 months post-intervention)
- Intervention Appropriateness (Clinicians)(Post-intervention)
研究者
Evelyn Arana, DrPH
Assistant Professor
Rutgers, The State University of New Jersey