Multimedia Patient Education

Lung Cancer Clinical Trial

Official title:

Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184534
• Other study ID #: 2010-0397
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: February 11, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Scheduled for a computed tomography (CT) guided lung biopsy

2. Literate English-speaking

Exclusion Criteria:

1. Refusal to participate

2. Current diagnosis of psychosis, dementia or other mentally altered state.

3. Monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA) during the procedure.

4. Patients who are clinically diagnosed as hearing and visually impaired.

5. Patients who have had prior image guided biopsies in our department.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Behavioral:
• Video
5 minute multimedia presentation (video)
• Questionnaires
2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Response to Subjective Anxiety Surveys	Subjective anxiety as measured on pre procedure and post procedure patient surveys.	1 day (pre and post lung biopsy procedure)	No

External Links

•   UT MD Anderson Cancer Center website