Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent of patients who complete the intervention
研究概览
简要总结
This pilot trial studies a video-based intervention in reducing anxiety in patients undergoing lung cancer screening. Giving a video-based intervention to patients prior to lung cancer screening may reduce anxiety and improve the well-being and quality of life.
详细描述
PRIMARY OBJECTIVES:
I. Test the feasibility and acceptability of the video-based intervention.
SECONDARY OBJECTIVES:
I. To describe incidence, degree, and duration of screen-related anxiety among individuals scheduled to undergo low-dose computed tomography (CT) scan (LDCT) for lung cancer screening (LCS).
II. To describe baseline patient characteristics and pre-screening anxiety levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study will be conducted in people scheduled to undergo baseline LDCT as part of the City of Hope (COH) LCS program
- •There are no restrictions related to performance status and life expectancy
- •All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study
排除标准
- •Patients who do not speak or read, because all intervention materials, including the video and written materials are in English
- •Subjects, who in the opinion of the investigator, may not be able to comply with study procedures
研究组 & 干预措施
Group I (standard of care)
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
干预措施: questionnaire administration (Other)
Group I (standard of care)
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
干预措施: quality-of-life assessment (Other)
Group I (standard of care)
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
干预措施: Best Practice (Other)
Group II (video-based intervention)
Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-RADS 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
干预措施: educational intervention (Other)
Group II (video-based intervention)
Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-RADS 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
干预措施: questionnaire administration (Other)
Group II (video-based intervention)
Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-RADS 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.
干预措施: quality-of-life assessment (Other)
结局指标
主要结局
Percent of patients who complete the intervention
时间窗: Baseline
Descriptive statistics will be presented on participation in all components of the intervention.
Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
时间窗: Up to 7 months
This self-reported measure will be completed by subjects who received the intervention.
次要结局
- Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire(Up to 7 months)
- Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire(Up to 7 months)
- Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)(Baseline to 7 months)