TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 594
- 试验地点
- 4
- 主要终点
- To assess shared decision making
研究概览
简要总结
Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.
Hypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.
Hypothesis 2: The investigators expect that a "booster" coaching session will increase adherence to repeat lung cancer screening (LCS).
详细描述
The investigators' primary objective is to compare the effectiveness of the TELESCOPE intervention vs. enhanced usual care (EUC) on shared decision-making (SDM) for lung cancer screening.
Secondary objectives are to test the effectiveness of the TELESCOPE intervention vs. EUC on screening uptake, adherence with diagnostic testing and annual testing, and smoking cessation referrals and receipt of tobacco treatment for current smokers. The investigators will also use a mixed methods approach to evaluate the implementation potential of navigator-led decision coaching for lung cancer screening (LCS ) and identify components and organizational and individual level characteristics that might facilitate or interfere with successful implementation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Inclusion Criteria Cluster Randomized Trial
- •Eligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:
- •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. Interviews (N=50)
- •Participants completing the semi-structured interviews will be:
- •A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3)
- •Age 18 or older
- •Fluent in English Online surveys (N=130)
- •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
- •- Cluster Randomized Trial
- •Excluded will be patients who:
- •Do not speak English
- •Have a history lung cancer
- •Were screened for lung cancer within the past 12 months
- •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 (N=50)
- •Providers/administrators will be excluded if they:
- •Are unable to provide informed consent Online surveys (N=130)
- •Are unable to provide informed consent
- •Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.
结局指标
主要结局
To assess shared decision making
时间窗: The change in baseline, three months and five years
Semi-structured interviews (qualitative data)
次要结局
- Tobacco treatment referral(The change in baseline, three months and five years)
- Uptake of Low-Dose CT Screening for Lung Cancer(Within 6 months post-intervention)
- Tobacco treatment referral(The change in baseline, three months and five years)
研究者
Anita Y. Kinney, PhD, RN
Director at Rutgers Cancer Institute
Rutgers, The State University of New Jersey