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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02220 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14169 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (standard of care) | Active Comparator | Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator. |
|
| Group II (video-based intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Undergo video-based intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients who complete the intervention | Descriptive statistics will be presented on participation in all components of the intervention. | Baseline |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Raz | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Other | Ancillary studies |
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| Best Practice | Other |
|
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| 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 |
| 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 |
| D009369 |
| Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |