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Using Videos in Advance Care Planning for Patients With Advanced Cancer

NCT ID: NCT01241929

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Advanced Cancer

Keywords

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advanced cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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video decision aid

Video decision aid arm

Group Type EXPERIMENTAL

video decision aid

Intervention Type BEHAVIORAL

video of CPR

Usual Care -- Verbal Description Arm

Verbal description of CPR (i.e., without the video).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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video decision aid

video of CPR

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. ability to provide informed consent,
3. cognitive ability to participate in the study
4. ability to communicate in English.

Exclusion Criteria

1. inability to make decisions,
2. non-English speaking,
3. new patient visit
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Angelo E. Volandes, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23233708 (View on PubMed)

Other Identifiers

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2008P000826

Identifier Type: -

Identifier Source: org_study_id