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

Anxiety Clinical Trial

Official title:

Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288416
• Other study ID #: 14169
• Secondary ID: NCI-2014-0222014
• Status: Completed
• Phase: N/A
• Start date: December 8, 2014
• Est. completion date: September 6, 2018

Study information

• Verified date: September 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Lung Carcinoma
• Lung Neoplasms
• No Evidence of Disease

Intervention

Other:
• educational intervention
Undergo video-based intervention
• questionnaire administration
Ancillary studies
• quality-of-life assessment
Ancillary studies
• Best Practice

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients who complete the intervention	Descriptive statistics will be presented on participation in all components of the intervention.	Baseline
Primary	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.	Up to 7 months
Secondary	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").	Baseline to 7 months
Secondary	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.	Up to 7 months
Secondary	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.	Up to 7 months