Clinical trial NCT02288416: Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening
Official title: Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
No Evidence of Disease
Lung Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percent of patients who complete the intervention
timeFrame: Baseline
measure: Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
timeFrame: Up to 7 months
Secondary outcomes:
measure: Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
timeFrame: Baseline to 7 months
measure: Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire
timeFrame: Up to 7 months
measure: Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Dan Raz
role: PRINCIPAL_INVESTIGATOR
References: