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

  • United States
    • 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
Behavioral: usual care
usual physician counseling on end of life care
Experimental: Intervention
video decision aid
Behavioral: video
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.

Sponsor

University of Alabama at Birmingham

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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