NCT01184534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

August 17, 2010

Last Update Submit

February 11, 2013

Conditions

Lung Cancer

Keywords

Lung BiopsyMultimedia patient education toolMultimedia Education ToolComputed tomography guided lung biopsyComputerized TomographyCTQuestionnaireLung nodules

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Questionnaires + Video

Behavioral: Video

Questionnaires

Behavioral: Questionnaires

Interventions

VideoBEHAVIORAL

5 minute multimedia presentation (video)

Questionnaires + Video
QuestionnairesBEHAVIORAL

2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.

Also known as: Survey
Questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

UT MD Anderson Cancer Center Patients scheduled for a computed tomography (CT) guided lung biopsy

You may qualify if:

  • Scheduled for a computed tomography (CT) guided lung biopsy
  • Literate English-speaking

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Videotape RecordingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stephen McRae, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

US(1)