A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility: Number of participants at each stage of the recruitment and retention cascade
研究概览
简要总结
Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.
详细描述
Lung cancer is a leading cause of cancer death, and lung cancer screening (LCS) with low-dose computed tomography can reduce lung cancer-related mortality among eligible individuals. However, uptake of LCS remains low, particularly among populations that face barriers to accessing preventive care.
Community health worker (CHW) interventions have been effective at promoting screening and reducing barriers to care in other cancer settings. This study was designed to develop and pilot test a multi-component intervention intended to improve LCS uptake and tobacco treatment utilization. The intervention includes four components: 1) patient outreach, 2) patient-centered shared decision-making about lung cancer screening, 3) tobacco treatment counseling for participants who currently smoke, and 4) navigation of logistical barriers to care.
The intervention was developed in partnership with a community advisory board composed of community stakeholders and individuals with lived experience, using principles from the Transcreation Framework for Community-Engaged Behavioral Interventions.
The pilot randomized controlled trial is being conducted within Baystate Health community health centers. Participants are randomized to one of three study arms: 1) enhanced usual care, which includes mailed lung cancer screening educational materials and usual screening care through the participant's primary care provider; 2) the multi-component intervention delivered by a community health worker; or 3) the same multi-component intervention delivered by a trained lay navigator, such as a research assistant or pre-medical student.
The study will evaluate the feasibility of implementing the intervention using different navigator models. Primary pilot outcomes include participant recruitment, measure completion, retention, intervention fidelity, and acceptability. Secondary outcomes include lung cancer screening and tobacco treatment utilization. The study will also explore potential mechanisms through which the intervention may influence screening, including knowledge about lung cancer screening and assistance overcoming logistical barriers to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the age of 50 and
- •Potentially eligible for LCS according to the Electronic Health Record smoking history.
- •Receive their primary care at Mason Square, High Street, or Brightwood community health centers.
- •English- or Spanish- speaking.
排除标准
- •Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).
- •Have received a lung cancer screen in the past.
研究组 & 干预措施
Enhanced Usual Care
Partcipants will receive educational materials about lung cancer screening
干预措施: Enhanced Usual Care (Other)
Community Health Worker-delivered Intervention
Participants will receive a four-part intervention delivered by a community health worker to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.
干预措施: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation (Behavioral)
Lay Navigator-delivered Intervention
Participants will receive the same four-part intervention delivered by a trained lay navigator to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.
干预措施: Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation (Behavioral)
结局指标
主要结局
Feasibility: Number of participants at each stage of the recruitment and retention cascade
时间窗: once a month until study trial ends, an average one year
Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.
Feasibility: Percentage of participants at each stage of the recruitment and retention cascade
时间窗: once a month until study trial ends, an average one year
Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.
Fidelity - SDM quality using OPTION Scale Observer OPTION Scale
时间窗: once a month until study trial ends, an average of 1 year
Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.
Fidelity - Completion of SDM required elements
时间窗: once a month until study trial ends, an average of 1 year
Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.
Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter
时间窗: once a month until study trial ends, an average of 1 year
Time in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Fidelity: Duration in minutes of smoking cessation counseling per encounter
时间窗: once a month until study trial ends, an average of 1 year
Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Fidelity: Percentage of participants with documented use of the SDM decision aid
时间窗: Monthly through study completion, an average of 1 year
Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.
Fidelity: Percentage of participants referred to tobacco treatment services, by type
时间窗: Monthly through study completion, an average of 1 year
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.
Acceptability of the CHW and lay navigator intervention to participants
时间窗: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), \~40-45 minutes, conducted in private at 3-month follow-up;
Acceptability of the intervention to CHWs and Lay navigators
时间窗: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.
Feasiblity
时间窗: once a month until study trial ends, an average one year
Recruitment \& enrollment: # of participants approached, met eligibility, and randomized Baseline Measures (see Table 5): Completeness of data collection. Retention: Loss of follow-up, reason for discontinuation, completeness of post-intervention data
Fidelity
时间窗: once a month until study trial ends, an average of 1 year
Referral to tobacco treatment services and type of referral (e.g., telephone quit line, in-person), nicotine replacement therapy.
Acceptability
时间窗: 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)
CHWs: Encounter logs documenting participant concerns and barriers to LCS Qualitative Interviews: Participants (N=15): Completed at the 3-month follow-up in a private setting, duration \~40-45 minutes, to assess the overall experience with the CHW intervention and barriers to LCS. CHWs (N=3): One 45-minute interview with each CHW after completing their last intervention delivery during the trial period.
次要结局
- LCS uptake(Baseline and post intervention, 3 months post study enrollment)
- Tobacco Treatment receipt(3 months post study enrollment)
- Tobacco Treatment Duration(3 months post study enrollment)
- Tobacco Cessation(3 months post study enrollment)
- Percentage of participants with a lung cancer screening (LCS) referral order(3 months post study enrollment)
- Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)(Baseline and post intervention, 3 months post study enrollment)
- Percentage of participants initiating tobacco treatment, by treatment type(3 months post study enrollment)
- Duration in weeks of tobacco treatment(3 months post study enrollment)
- Number of self-reported quit attempts per participant(3 months post study enrollment)
- LCS referral(3 months post study enrollment)
研究者
Eduardo
Assistant Professor Departments of Medicine and Healthcare Delivery and Population Sciences
Baystate Medical Center