Anxiety, Lung Carcinoma, No Evidence of Disease
Conditions
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.
Interventions
OTHEReducational intervention
Undergo video-based intervention
OTHERquestionnaire administration
Ancillary studies
OTHERquality-of-life assessment
Ancillary studies
OTHERBest Practice
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients who complete the intervention | 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 | Up to 7 months | This self-reported measure will be completed by subjects who received the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI) | Baseline to 7 months | 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). |
| Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire | Up to 7 months | 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. |
| Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire | Up to 7 months | 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. |
Countries
United States
Outcome results
None listed