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Completed

NCT Number: NCT01241929

Using Videos in Advance Care Planning for Patients With Advanced Cancer

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

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video decision aid

Behavioral

video of CPR

Primary outcomes

  1. preferences for CPR

    Time frame: within one hour after oncology visit

    CPR preference after visit to oncologist

Secondary outcomes

  1. knowledge of CPR

    Time frame: baseline and post-intervention

    assess knowledge of CPR

  2. stability of preferences

    Time frame: after 6-8 weeks

    assess CPR preferences again

  3. predictors of preferences

    Time frame: post-intervention

    predictors of preferences for CPR

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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