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

NCT02288416 | Completed DMC

• 2 other identifiers: 14169NCI-2014-02220
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; No Evidence of Disease; Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  Baseline to 7 months

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

  Up to 7 months

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

  Up to 7 months

Study Arms (2)

Group I (standard of care)

ACTIVE COMPARATOR

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; Other: quality-of-life assessment; Other: Best Practice

Group II (video-based intervention)

EXPERIMENTAL

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: educational intervention; Other: questionnaire administration; Other: quality-of-life assessment

Interventions

educational intervention OTHER

Undergo video-based intervention

Also known as: intervention, educational

Group II (video-based intervention)

questionnaire administration OTHER

Ancillary studies

Group I (standard of care); Group II (video-based intervention)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Group I (standard of care); Group II (video-based intervention)

Best Practice OTHER

Also known as: standard of care, standard therapy

Group I (standard of care)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Lung Neoplasms

Interventions

Early Intervention, Educational; Methods; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Dan Raz

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: December 8, 2014
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

US (1)