Anxiety Clinical Trial
Official title:
Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Verified date | September 2018 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 6, 2018 |
Est. primary completion date | September 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of patients who complete the intervention | Descriptive statistics will be presented on participation in all components of the intervention. | Baseline | |
Primary | Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey | This self-reported measure will be completed by subjects who received the intervention. | Up to 7 months | |
Secondary | Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI) | The survey is used to diagnose anxiety and to distinguish it from depressive syndromes, with items rated on a 4-point scale (with 1 being "Almost Never" and 4 being "Almost Always"). | Baseline to 7 months | |
Secondary | Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire | The SF-12 is designed for assessment of general health status and contains 7 items that measure physical functioning, role functioning, bodily pain, energy/fatigue, social functioning, mental health, emotional functioning, general health perceptions, and changes in health. | Up to 7 months | |
Secondary | Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire | This questionnaire is a non-validated adapted version of a validated two part tool used to assess the psychological impact to breast cancer screening using mammography. | Up to 7 months |
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