Using Videos in Advance Care Planning for Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

A Pilot Study of Using Video Images in Advance Care Planning in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241929
• Other study ID #: 2008P000826
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: July 9, 2012
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• video decision aid
video of CPR

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preferences for CPR	CPR preference after visit to oncologist	within one hour after oncology visit	No
Secondary	knowledge of CPR	assess knowledge of CPR	baseline and post-intervention	No
Secondary	stability of preferences	assess CPR preferences again	after 6-8 weeks	No
Secondary	predictors of preferences	predictors of preferences for CPR	post-intervention	No