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Completed

NCT Number: NCT02288416

Video-Based Intervention in Reducing Anxiety in Patients Undergoing 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.

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Key information

Conditions

Anxiety Anxiety Disorders Lung Carcinoma Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site No Evidence of Disease Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Undergo video-based intervention

Other names: intervention, educational

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

Best Practice

Other

Other names: standard of care, standard therapy

Primary outcomes

  1. Percent of patients who complete the intervention

    Time frame: Baseline

    Descriptive statistics will be presented on participation in all components of the intervention.

  2. Patient satisfaction with the timing, content, and delivery of the video-based intervention assessed by survey

    Time frame: Up to 7 months

    This self-reported measure will be completed by subjects who received the intervention.

Secondary outcomes

  1. Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)

    Time frame: Baseline to 7 months

    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").

  2. Health-related quality of life as assessed by the mean survey score of the Short Form-12 (SF-12) questionnaire

    Time frame: Up to 7 months

    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.

  3. Consequences of screening, assessed by the mean survey score of the Consequences of Screening in Lung Cancer (COS-LC) questionnaire

    Time frame: Up to 7 months

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2014
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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