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CompletedNCT03251976Updated Aug 19, 2019

CPR Decision Aid For Patients With Advanced Gynecologic Malignancies

An interventional study of video and usual care in Advance Care Planning, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Advance Care Planning

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Keywords

  • ovarian cancer
  • cardiopulmonary resuscitation
  • end of life care
  • endometrial cancer
  • cervical cancer
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients with stage III or greater cervical, ovarian, or uterine malignancies
  • receiving chemotherapy at UAB gynecologic oncology infusion center

Exclusion criteria

Exclusion Criteria:

  • early stage gynecologic cancer
  • receiving chemotherapy at a different location
  • Non-English speaking
  • deafness
  • blindness
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention

    video decision aid

    Behavioral: video

  • Active comparator
    Usual care

    Behavioral: usual care

Interventions

  • Behavioralvideo

    informational video

  • Behavioralusual care

    usual physician counseling on end of life care

05

What researchers measure

Primary outcomes

  1. CPR knowledge

    Patient CPR knowledge assessment score (0-4)

    Time frame: one month after intervention

Secondary outcomes

  1. CPR preference

    Patient CPR preference (Yes, No, Unsure)

    Time frame: baseline

  2. CPR preference

    Patient CPR preference (Yes, No, Unsure)

    Time frame: one month after intervention

  3. CPR knowledge

    Patient CPR knowledge assessment score (0-4)

    Time frame: baseline

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Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03251976
Lead sponsor
University of Alabama at Birmingham
Responsible party
Kerri Bevis (Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 16, 2017
Start date
Nov 6, 2018
Primary completion
May 6, 2019
Completion
May 6, 2019
Last update
Aug 19, 2019

Study contacts

Kerri Bevis, MD, MSPH
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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