- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251976
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies
August 15, 2019 updated by: Kerri Bevis, University of Alabama at Birmingham
The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies
The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy.
We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- patients with stage III or greater cervical, ovarian, or uterine malignancies
- receiving chemotherapy at UAB gynecologic oncology infusion center
Exclusion Criteria:
- early stage gynecologic cancer
- receiving chemotherapy at a different location
- Non-English speaking
- deafness
- blindness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
usual physician counseling on end of life care
|
Experimental: Intervention
video decision aid
|
informational video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPR knowledge
Time Frame: one month after intervention
|
Patient CPR knowledge assessment score (0-4)
|
one month after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPR preference
Time Frame: baseline
|
Patient CPR preference (Yes, No, Unsure)
|
baseline
|
CPR preference
Time Frame: one month after intervention
|
Patient CPR preference (Yes, No, Unsure)
|
one month after intervention
|
CPR knowledge
Time Frame: baseline
|
Patient CPR knowledge assessment score (0-4)
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kerri Bevis, MD, MSPH, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2018
Primary Completion (Actual)
May 6, 2019
Study Completion (Actual)
May 6, 2019
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
August 15, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F12345678
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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