Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening

City of Hope Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety No Evidence of Disease Lung Carcinoma

Interventions

educational interventionOTHER

Undergo video-based intervention

questionnaire administrationOTHER

Ancillary studies

quality-of-life assessmentOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Outcomes

Primary Outcomes

Percent of patients who complete the intervention

Descriptive statistics will be presented on participation in all components of the intervention.

Time frame: 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.

Time frame: Up to 7 months

Secondary Outcomes

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").

Time frame: Baseline to 7 months

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.

Time frame: 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.

Time frame: Up to 7 months

Data from ClinicalTrials.gov

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