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

NCT ID: NCT02288416

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-08
• Study Completion Date: 2018-09-06

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.

Conditions

Anxiety; No Evidence of Disease; Lung Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group I (standard of care)

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

Group Type: ACTIVE_COMPARATOR

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Best Practice

Intervention Type: OTHER

Group II (video-based intervention)

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.

Group Type: EXPERIMENTAL

educational intervention

Intervention Type: OTHER

Undergo video-based intervention

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Interventions

educational intervention

Undergo video-based intervention

Intervention Type: OTHER

questionnaire administration

Ancillary studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

Best Practice

Intervention Type: OTHER

Other Intervention Names

intervention, educational; quality of life assessment; standard of care; standard therapy

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Raz

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2014-02220

Identifier Type: REGISTRY

Identifier Source: secondary_id

14169

Identifier Type: OTHER

Identifier Source: secondary_id

14169

Identifier Type: -

Identifier Source: org_study_id