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

Primary Purpose

Anxiety, No Evidence of Disease, Lung Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
questionnaire administration
quality-of-life assessment
Best Practice
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (standard of care)

Group II (video-based intervention)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percent of patients who complete the intervention
Descriptive statistics will be presented on participation in all components of the intervention.
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.

Secondary Outcome Measures

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").
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.
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.

Full Information

First Posted
November 7, 2014
Last Updated
September 7, 2018
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02288416
Brief Title
Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening
Official Title
Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 8, 2014 (undefined)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, No Evidence of Disease, Lung Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.
Arm Title
Group II (video-based intervention)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Undergo video-based intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Primary Outcome Measure Information:
Title
Percent of patients who complete the intervention
Description
Descriptive statistics will be presented on participation in all components of the intervention.
Time Frame
Baseline
Title
Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey
Description
This self-reported measure will be completed by subjects who received the intervention.
Time Frame
Up to 7 months
Secondary Outcome Measure Information:
Title
Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
Description
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
Title
Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire
Description
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
Title
Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Raz
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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