CPR Decision Aid For Patients With Advanced Gynecologic M... | NCT03251976

Studies
CPR Decision Aid For Patients With Advanced Gynecologic Malignancies

NCT03251976

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Aug 19, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Advance Care Planning

Interventions

video
usual care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2018Actual

Primary Completion Date

May 6, 2019Actual

Completion Date

May 6, 2019Actual

First Submitted Date

Aug 14, 2017

First Submission Date that Met QC Criteria

Aug 14, 2017

First Posted Date

Aug 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2019

Last Update Posted Date

Aug 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kerri Bevis, Associate Professor, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	video decision aid	Behavioral: video
Usual care	Active Comparator		Behavioral: usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video	Behavioral	informational video	Intervention
usual care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPR knowledge	Patient CPR knowledge assessment score (0-4)	one month after intervention

Secondary Outcomes

Measure	Description	Time Frame
CPR preference	Patient CPR preference (Yes, No, Unsure)	baseline
CPR preference	Patient CPR preference (Yes, No, Unsure)	one month after intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerri Bevis, MD, MSPH	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D016889	Endometrial Neoplasms
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014743	Videotape Recording

Ancestor Terms

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology

Browse Leaves

Not provided

Browse Branches

Not provided