Lung CancerNCT01184534
Multimedia Patient Education
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objective: To compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Video and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UT MD Anderson Cancer Center Patients scheduled for a computed tomography (CT) guided lung biopsy
Who may be able to join
- Scheduled for a computed tomography (CT) guided lung biopsy
- Literate English-speaking
Who cannot join
- Refusal to participate
- Current diagnosis of psychosis, dementia or other mentally altered state.
- Monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA) during the procedure.
- Patients who are clinically diagnosed as hearing and visually impaired.
- Patients who have had prior image guided biopsies in our department.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education
Objective:
To compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.
Read the detailed description
If you agree to take part in this study, you will complete a questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After you have completed the questionnaire, you will be randomly assigned (as in the flip of a coin) to Group 1 or Group 2. You will have an equal chance of being in either group.
If you are in Group 1, you will receive routine information before the lung biopsy and you will watch a video on a handheld or laptop machine with headphones. The video is designed to help you understand the biopsy procedure. This video should last about 5 minutes. You will then complete a questionnaire that asks how you feel after watching the video. It will take about 5 minutes to complete.
If you are in Group 2, you will receive routine information before the lung biopsy. You will then complete another questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After your routine lung biopsy, both groups will complete a questionnaire that asks how you feel after the procedure. It will take about 5 minutes to complete.
For Group 1, the total time to complete the questionnaires and watch the video will be 20 minutes.
For Group 2, the total time to complete the questionnaires will be 15 minutes.
Length of Study:
Your participation in this study will be over once you complete the questionnaire after your lung biopsy.
This is an investigational study.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Video, Questionnaires
- Keywords
- Lung Biopsy, Multimedia patient education tool, Multimedia Education Tool, Computed tomography guided lung biopsy, Computerized Tomography, CT, Questionnaire, Lung nodules
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
5 minute multimedia presentation (video)
QuestionnairesBehavioural
Also called Survey
2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires + Video | Not described Receives: Behavioral: Video | |
| Questionnaires | Not described Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response to Subjective Anxiety Surveys
Subjective anxiety as measured on pre procedure and post procedure patient surveys.
Measured: 1 day (pre and post lung biopsy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen McRae, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184534
- Sponsor's protocol ID
- 2010-0397
- Status last verified
- Feb 2013
- First submitted
- 17 Aug 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education
- ClinicalTrials.gov ID
- NCT01184534
- Acronym / sponsor ID
- 2010-0397
- Conditions
- Lung Cancer
- Keywords
- Lung Biopsy, Multimedia patient education tool, Multimedia Education Tool, Computed tomography guided lung biopsy, Computerized Tomography, CT, Questionnaire, Lung nodules
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Aug 2010 (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.
Objective:
To compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.
Detailed description
If you agree to take part in this study, you will complete a questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After you have completed the questionnaire, you will be randomly assigned (as in the flip of a coin) to Group 1 or Group 2. You will have an equal chance of being in either group.
If you are in Group 1, you will receive routine information before the lung biopsy and you will watch a video on a handheld or laptop machine with headphones. The video is designed to help you understand the biopsy procedure. This video should last about 5 minutes. You will then complete a questionnaire that asks how you feel after watching the video. It will take about 5 minutes to complete.
If you are in Group 2, you will receive routine information before the lung biopsy. You will then complete another questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After your routine lung biopsy, both groups will complete a questionnaire that asks how you feel after the procedure. It will take about 5 minutes to complete.
For Group 1, the total time to complete the questionnaires and watch the video will be 20 minutes.
For Group 2, the total time to complete the questionnaires will be 15 minutes.
Length of Study:
Your participation in this study will be over once you complete the questionnaire after your lung biopsy.
This is an investigational study.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Questionnaires + Video | – | Behavioral: Video |
| Questionnaires | – | Behavioral: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center Patients scheduled for a computed tomography (CT) guided lung biopsy
Key inclusion criteria (2 listed)
- Scheduled for a computed tomography (CT) guided lung biopsy
- Literate English-speaking
Key exclusion criteria (5 listed)
- Refusal to participate
- Current diagnosis of psychosis, dementia or other mentally altered state.
- Monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA) during the procedure.
- Patients who are clinically diagnosed as hearing and visually impaired.
- Patients who have had prior image guided biopsies in our department.
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 |
|---|---|---|
| Video5 minute multimedia presentation (video) | Behavioural | Questionnaires + Video |
| QuestionnairesAlso: Survey2 questionnaires pre and post procedure taking approximately 15 minutes each to complete. | Behavioural | Questionnaires |
Primary outcome
Patient Response to Subjective Anxiety Surveys
Time frame: 1 day (pre and post lung biopsy procedure)
Subjective anxiety as measured on pre procedure and post procedure patient surveys.
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 12 Feb 2013.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Stephen McRae, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by M.D. Anderson Cancer 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 2 inclusion and 5 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 12 Feb 2013. 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?
Patient Response to Subjective Anxiety Surveys (time frame: 1 day (pre and post lung biopsy procedure)). 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 12 Feb 2013.