NCT03251976

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

August 14, 2017

Last Update Submit

August 15, 2019

Conditions

Advance Care Planning

Keywords

ovarian cancercardiopulmonary resuscitationend of life careendometrial cancercervical cancer

Outcome Measures

Primary Outcomes (1)

  • CPR knowledge

    Patient CPR knowledge assessment score (0-4)

    one month after intervention

Secondary Outcomes (3)

  • CPR preference

    baseline

  • CPR preference

    one month after intervention

  • CPR knowledge

    baseline

Study Arms (2)

Intervention

EXPERIMENTAL

video decision aid

Behavioral: video

Usual care

ACTIVE COMPARATOR
Behavioral: usual care

Interventions

videoBEHAVIORAL

informational video

Intervention
usual careBEHAVIORAL

usual physician counseling on end of life care

Usual care

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsUterine Cervical Neoplasms

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine DiseasesUterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Kerri Bevis, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

November 6, 2018

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)