Cardiopulmonary Resuscitation (CPR) Video To Enhance Advance Care Planning In Advanced Upper Gastrointestinal Cancer Patients

Study Overview

Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients

Advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. It does not matter if the patients are ill or healthy. It is especially important for people who have diseases that cannot be cured. It allows people to make sure their wishes are respected if they become very sick or are dying. Thinking about these issues can be upsetting. But, for many people, it is helpful. This type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made

N/A

Pancreas and Hepatobiliary Cancer Patients

BEHAVIORAL: (CPR) video and questionnaires
BEHAVIORAL: cardiopulmonary resuscitation (CPR) narrative script and questionnaires

10-043

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-04-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-15
First Submitted that Met QC Criteria 2010-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-16
First Posted (ESTIMATED) 2010-04-19	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: cardiopulmonary resuscitation (CPR) video This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative script in advance directive (AD) completion over a 1 month time frame post intervention.	BEHAVIORAL: (CPR) video and questionnaires Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)
: cardiopulmonary resuscitation (CPR) narrative script This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative in advance directive (AD) completion over a 1 month timeframe post intervention.	BEHAVIORAL: cardiopulmonary resuscitation (CPR) narrative script and questionnaires Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)

Participant Group/Arm

Intervention/Treatment

: cardiopulmonary resuscitation (CPR) video

This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative script in advance directive (AD) completion over a 1 month time frame post intervention.

BEHAVIORAL: (CPR) video and questionnaires

Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)

: cardiopulmonary resuscitation (CPR) narrative script

This pilot study involves a two-arm parallel design comparing the effectiveness of a CPR video versus a CPR narrative in advance directive (AD) completion over a 1 month timeframe post intervention.

BEHAVIORAL: cardiopulmonary resuscitation (CPR) narrative script and questionnaires

Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)

Primary Outcome Measures	Measure Description	Time Frame
To document advance directive (AD)completion		1 month post-test

Secondary Outcome Measures	Measure Description	Time Frame
To assess patient uncertainty about, knowledge of, and preference for CPR.		pre and post randomization
To longitudinally follow discussions about ADs and nature of hospitalizations		6 months post-intervention

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Primary pancreatic or hepatobiliary cancer (including ampullary carcinoma)as well as gastric and/or esophageal cancers, excluding neuroendocrine histology
Progressive disease: Locally advanced or metastatic disease with progression on at least one course of treatment (surgery, radiation, or chemotherapy), or untreated patients unfit for therapy because of comorbidities or ECOG performance status >2, and finally, patients with ECOG performance status 2 -- patients must have discussed on at least one occasion with the treating investigator oncologist that their cancer cannot be cured
In the estimation of the treating physician investigator, life expectancy ≤ 1 year
Known to a GI medical oncology MSKCC clinic: Patients who have already established a relationship with a GI medical oncologist (who is an investigator on this protocol) after at least one new visit in the clinic (or as an in-patient), have MSKCC pathologist confirmed cancer of an above histology, and express an initial intent to be followed primarily at MSKCC
English speaking*
Able to provide informed consent
Age greater than or equal to 18 years
Do not have an advance directive or living will
English is the validated language in one of the study tools, and the language in which information is communicated in the narrative and video.

Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental functioning" (3 or more errors). SPMSQ in appendix.
Any patient psychological state deemed by the treating physician to pose any risk of psychological harm by issues raised in a discussion of the trial, or in its testing procedures. Any subject who may become upset during any aspect or discussion of the study will be offered counseling services.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Massachusetts General Hospital
Mount Sinai Hospital, New York

Investigators

PRINCIPAL_INVESTIGATOR: Eileen O'Reilly, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record