Clinical trial NCT01184534: Multimedia Patient Education
Official title: Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Biopsy
Multimedia patient education tool
Multimedia Education Tool
Computed tomography guided lung biopsy
Computerized Tomography
CT
Questionnaire
Lung nodules
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UT MD Anderson Cancer Center Patients scheduled for a computed tomography (CT) guided lung biopsy

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Response to Subjective Anxiety Surveys
timeFrame: 1 day (pre and post lung biopsy procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Stephen McRae, MD
role: PRINCIPAL_INVESTIGATOR
References: