Using Videos in Advance Care Planning for Patients With Advanced Cancer

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: video decision aid

• Registration Number: NCT01241929
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2012-01
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
video decision aid	video decision aid	Video decision aid arm

Primary Outcome Measures

Name	Time	Method
preferences for CPR	within one hour after oncology visit	CPR preference after visit to oncologist

Secondary Outcome Measures

Name	Time	Method
knowledge of CPR	baseline and post-intervention	assess knowledge of CPR
stability of preferences	after 6-8 weeks	assess CPR preferences again
predictors of preferences	post-intervention	predictors of preferences for CPR

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States