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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Lung Carcinoma; No Evidence of Disease
• Intervention / Treatment: Other: questionnaire administration; Other: quality-of-life assessment; Other: Best Practice; Other: educational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: Best Practice; Other Names: standard of care; standard therapy
Experimental: 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.	Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: educational intervention; Undergo video-based intervention; Other Names: intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients who complete the intervention	Descriptive statistics will be presented on participation in all components of the intervention.	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.	Up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: December 8, 2014
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): September 6, 2018

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Anxiety Disorders
• Other Study ID Numbers: 14169 (Other Identifier: City of Hope Medical Center); NCI-2014-02220 (Registry Identifier: CTRP (Clinical Trial Reporting Program))