AnxietyNCT02288416
Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening
A study testing educational intervention, questionnaire administration and quality-of-life assessment in people with Anxiety and No Evidence of Disease, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, No Evidence of Disease, Lung Carcinoma
- What is being tested?
- educational intervention, questionnaire administration and quality-of-life assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2014to 6 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the feasibility and acceptability of the video-based intervention.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Anxiety, No Evidence of Disease, Lung Carcinoma
- Being tested
- educational intervention, questionnaire administration, quality-of-life assessment, Best Practice
- Medical subject headings
- Anxiety Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Undergo video-based intervention
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
Best PracticeOther
Also called standard of care, standard therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: educational intervention; Other: questionnaire administration; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who complete the intervention
Descriptive statistics will be presented on participation in all components of the intervention.
Measured: 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.
Measured: Up to 7 months
Secondary outcomes (3)
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").
Measured: 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.
Measured: 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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start8 Dec 2014
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dan Raz, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288416
- Sponsor's protocol ID
- 14169
- Other IDs
- NCI-2014-02220, 14169
- Status last verified
- Sep 2018
- First submitted
- 7 Nov 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Video-Based Intervention to Reduce Psychological Harm Associated With Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT02288416
- Acronym / sponsor ID
- 14169
- Conditions
- Anxiety, No Evidence of Disease, Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Dec 2014
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test the feasibility and acceptability of the video-based intervention.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (standard of care) | Active comparator | Other: questionnaire administration, Other: quality-of-life assessment, Other: Best PracticePatients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator. |
| Group II (video-based intervention) | Experimental | Other: educational intervention, Other: questionnaire administration, Other: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionAlso: intervention, educationalUndergo video-based intervention | Other | Group II (video-based intervention) |
| questionnaire administrationAncillary studies | Other | Group I (standard of care), Group II (video-based intervention) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Group I (standard of care), Group II (video-based intervention) |
| Best PracticeAlso: standard of care, standard therapy | Other | Group I (standard of care) |
Primary outcome
Percent of patients who complete the intervention
Time frame: Baseline
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
Time frame: Up to 7 months
This self-reported measure will be completed by subjects who received the intervention.
3 secondary outcomes
Patient screen-related anxiety as assessed by the mean score of the State Trait Anxiety Inventory (STAI)
Time frame: Baseline to 7 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Raz principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, questionnaire administration and quality-of-life assessment in people with Anxiety and No Evidence of Disease, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients who complete the intervention (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.