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

City of Hope

Status: Completed

Conditions: Lung Carcinoma; Anxiety; No Evidence of Disease

Treatments: Other: questionnaire administration; Other: quality-of-life assessment; Other: Best Practice; Other: educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02288416

NCI-2014-02220 (Registry Identifier)

14169 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group I (standard of care)

Active Comparator group

Description:

Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.

Treatment:

Other: Best Practice

Other: quality-of-life assessment

Other: questionnaire administration

Group II (video-based intervention)

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Other: quality-of-life assessment

Other: questionnaire administration