Strengthening Awareness and Community Resources for Early Detection of Lung Cancer Through Navigation Guided Screening Trial (SACRED LUNGS Aims 1.2-3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Completion of chest computed tomography (CT) (Aim 1.2)
研究概览
简要总结
This clinical trial studies whether tailored patient navigation (PN) works to improve the uptake of lung cancer screening (LCS) in tribal communities in western Washington state. Lung cancer is the leading cause of cancer death in the United States among American Indian (AI) and Alaska Native (AN) people, and the incidence of lung cancer is higher in this population in the Northern and Southern Plains, Alaska, and Pacific Coast regions. In Washington state, AI/AN people also have twice the rate of commercial cigarette smoking than the overall population. LCS with annual low-dose chest computed tomography (CT) can reduce lung cancer death and is recommended in people 50-80 years of age with current or recent (within 15 years) tobacco use and a 20 pack-year or greater smoking history. Despite this, AI and AN people are less likely to receive LCS which may be due to barriers they face making it difficult to receive LCS. PN services are designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN services in this trial have been tailored for the tribal communities in western Washington state. The services are designed to help participants overcome the unique barriers that their tribal communities face and improve the uptake of LCS.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
ARM 2: Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their primary care physician (PCP) for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
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
- Single (Investigator)
盲法说明
Research staff and study coordinators will be blinded to study arm while patient, navigators, and providers will be aware of study arm.
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
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Between ages 50-77
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Seen by a PCP at a participating clinic (South Puget Intertribal Planning Agency [SPIPA] or Muckleshoot) within the past three years
- •Potential participants who want to establish care at an eligible clinic will be connected to a PCP
- •AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
- •AIM 2 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
- •AIM 2 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial
- •AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: At least 18 years of age
- •AIM 3 CLINICAL STAFF SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Affiliation with Muckleshoot or SPIPA (one of the 6 community partnering clinics) as a provider, or supportive staff member
- •AIM 3 PATIENT SURVEYS AND SEMI-STRUCTURED INTERVIEWS: Patient participated in the aim 1.2 trial
排除标准
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of lung cancer
- •AIM 1.2 RANDOMIZED CONTROLLED TRIAL: Personal history of any cancer within 5 years except for basal cell or squamous cell skin carcinoma
研究组 & 干预措施
Arm 1 (tailored PN)
Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
干预措施: Interview (Other)
Arm 1 (tailored PN)
Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
干预措施: Educational Intervention (Other)
Arm 1 (tailored PN)
Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
干预措施: Survey Administration (Other)
Arm 1 (tailored PN)
Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
干预措施: Electronic Health Record Review (Other)
Arm 1 (tailored PN)
Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.
干预措施: Patient Navigation (Behavioral)
Arm 2 (enhanced usual care, delayed tailored PN)
Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
干预措施: Electronic Health Record Review (Other)
Arm 2 (enhanced usual care, delayed tailored PN)
Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
干预措施: Interview (Other)
Arm 2 (enhanced usual care, delayed tailored PN)
Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
干预措施: Patient Navigation (Behavioral)
Arm 2 (enhanced usual care, delayed tailored PN)
Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
干预措施: Best Practice (Other)
Arm 2 (enhanced usual care, delayed tailored PN)
Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.
干预措施: Survey Administration (Other)
结局指标
主要结局
Completion of chest computed tomography (CT) (Aim 1.2)
时间窗: Up to 6 months
Will be compared between arms using the Cochran-Mantel-Haenszel (CMH) test, accounting for the stratification variables used during randomization. Completion rates will also be estimated in each arm and 95% confidence intervals for the rates and their difference will be calculated using Wilson's score method. The single primary outcome will be tested using two-sided α = 0.05.
次要结局
- Completion of chest CT (Aim 2)(Up to 6 months)
- Navigation care engagement (Aim 2)(Up to 21 months)
- Completion of chest CT (Aim 3)(Up to 15 months)
- Completion of next diagnostic step in LCS follow-up(Up to 15 months)
- Completion of low dose computed tomography of the chest (Aim 1.2)(Up to 21 months)
- Lung cancer screening (LCS) knowledge (Aim 1.2)(At 21 months)
- Health-related quality of life (Aim 1.2)(At 21 months)
- Rate of reported 30-day cessation period (Aim 1.2)(Up to 6 months)