Using Videos in Advance Care Planning for Patients With A... | NCT01241929

Studies
Using Videos in Advance Care Planning for Patients With Advanced Cancer

NCT01241929

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Advanced Cancer

Interventions

video decision aid

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

Jul 2012

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

Apr 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

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

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.

Detailed Description

A.1. Aim 1: To recruit 150 subjects with advanced cancer and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting CPR (intervention) or 2. a verbal narrative describing the CPR.

Hypothesis 1: It is feasible to recruit and randomize 150 subjects with advanced cancer.

A.2. Aim 2: To compare the care preferences for CPR among 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt NOT to have CPR compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of CPR for 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
video decision aid	Experimental	Video decision aid arm	Behavioral: video decision aid
Usual Care -- Verbal Description Arm	No Intervention	Verbal description of CPR (i.e., without the video).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video decision aid	Behavioral	video of CPR	video decision aid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
preferences for CPR	CPR preference after visit to oncologist	within one hour after oncology visit

Secondary Outcomes

Measure	Description	Time Frame
knowledge of CPR	assess knowledge of CPR	baseline and post-intervention
stability of preferences	assess CPR preferences again	after 6-8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of cancer that falls under one of the following: A. All patients with brain cancer, inoperable hepatocellular/bile duct/gallbladder cancer, incurable non-small cell lung carcinoma (wet IIIb or IV), extensive stage small cell lung cancer, inoperable mesothelioma, inoperable pancreatic cancer or; metastatic gastric or esophageal cancer, metastatic melanoma, OR B. Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma, OR C. Less than one year prognosis.
ability to provide informed consent,
cognitive ability to participate in the study
ability to communicate in English.

Exclusion Criteria:

inability to make decisions,
non-English speaking,
new patient visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23233708	Derived	Volandes AE, Paasche-Orlow MK, Mitchell SL, El-Jawahri A, Davis AD, Barry MJ, Hartshorn KL, Jackson VA, Gillick MR, Walker-Corkery ES, Chang Y, Lopez L, Kemeny M, Bulone L, Mann E, Misra S, Peachey M, Abbo ED, Eichler AF, Epstein AS, Noy A, Levin TT, Temel JS. Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer. J Clin Oncol. 2013 Jan 20;31(3):380-6. doi: 10.1200/JCO.2012.43.9570. Epub 2012 Dec 10.