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Completed

NCT Number: NCT01105806

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

(CPR) video and questionnaires

Behavioral

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 and questionnaires

Behavioral

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

Primary outcomes

  1. To document advance directive (AD)completion

    Time frame: 1 month post-test

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Massachusetts General Hospital
  • Mount Sinai Hospital, New York

Registry information

Official study title

The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2010
Registry last updated
Jul 16, 2015

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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