Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- City of Hope Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percent of patients who complete the intervention
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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. III. To describe the preliminary outcomes on screen-related anxiety for patients both not in the intervention group and those in the intervention group. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator. GROUP II: 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-Imaging Reporting and Data Systems \[RADS\] 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results. After completion of LCS, patients are followed up at 1 week and then at 3 and 7 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Percent of patients who complete the intervention
Time Frame: 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
Time Frame: Up to 7 months
This self-reported measure will be completed by subjects who received the intervention.
Secondary Outcomes
- 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)