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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01105806
Enrollment
57
Registered
2010-04-19
Start date
2010-04-30
Completion date
2015-07-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas and Hepatobiliary Cancer Patients

Keywords

advance directive, CPR Intervention, Video, Narrative, 10-043

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

Interventions

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)

BEHAVIORALcardiopulmonary 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)

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Mount Sinai Hospital, New York
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To document advance directive (AD)completion1 month post-test

Secondary

MeasureTime 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 hospitalizations6 months post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026