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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01105806
First received: April 14, 2010
Last updated: May 22, 2014
Last verified: May 2014

April 14, 2010
May 22, 2014
April 2010
April 2015   (final data collection date for primary outcome measure)
To document advance directive (AD)completion [ Time Frame: 1 month post-test ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01105806 on ClinicalTrials.gov Archive Site
  • To assess patient uncertainty about, knowledge of, and preference for CPR. [ Time Frame: pre and post randomization ] [ Designated as safety issue: No ]
  • To longitudinally follow discussions about ADs and nature of hospitalizations [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
Same as current
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Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients
The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Pancreas and Hepatobiliary Cancer Patients
  • 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)
  • 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)
  • 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.
    Intervention: Behavioral: (CPR) video and questionnaires
  • 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.
    Intervention: Behavioral: cardiopulmonary resuscitation (CPR) narrative script and questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105806
10-043
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Massachusetts General Hospital
  • Mount Sinai Hospital, New York
Principal Investigator: Eileen O'Reilly, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP