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

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ClinicalTrials.gov Identifier: NCT01105806
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : July 16, 2015
Sponsor:
Collaborators:
Massachusetts General Hospital
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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

Condition or disease Intervention/treatment
Pancreas and Hepatobiliary Cancer Patients Behavioral: (CPR) video and questionnaires Behavioral: cardiopulmonary resuscitation (CPR) narrative script and questionnaires

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria
Study Start Date : April 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR
U.S. FDA Resources

Group/Cohort 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 :
  1. To document advance directive (AD)completion [ Time Frame: 1 month post-test ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from the MSKCC GI medical oncology group of listed study investigators, and as above, 18 years of age or older with no advance directive completed, and will be English speaking, due to the study tools being based in English.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105806


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Massachusetts General Hospital
Mount Sinai Hospital, New York
Investigators
Principal Investigator: Eileen O'Reilly, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01105806     History of Changes
Other Study ID Numbers: 10-043
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
advance directive
CPR Intervention
Video
Narrative
10-043

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases