Pancreas and Hepatobiliary Cancer PatientsNCT01105806
Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients
An observational study of Pancreas and Hepatobiliary Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas and Hepatobiliary Cancer Patients
- What is being tested?
- (CPR) video and questionnaires and cardiopulmonary resuscitation (CPR) narrative script and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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
- Being tested
- (CPR) video and questionnaires, cardiopulmonary resuscitation (CPR) narrative script and questionnaires
- Keywords
- advance directive, CPR Intervention, Video, Narrative, 10-043
- Medical subject headings
- Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(CPR) video and questionnairesBehavioural
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 questionnairesBehavioural
Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: cardiopulmonary resuscitation (CPR) narrative script and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document advance directive (AD)completion
Measured: 1 month post-test
Secondary outcomes (2)
To assess patient uncertainty about, knowledge of, and preference for CPR.
Measured: pre and post randomization
To longitudinally follow discussions about ADs and nature of hospitalizations
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas and Hepatobiliary Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Mount Sinai Hospital, New York
- Responsible party
- Sponsor
- Investigators
- Eileen O'Reilly, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105806
- Sponsor's protocol ID
- 10-043
- Status last verified
- Jul 2015
- First submitted
- 14 Apr 2010
- Last updated
- 16 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria
- ClinicalTrials.gov ID
- NCT01105806
- Acronym / sponsor ID
- 10-043
- Keywords
- advance directive, CPR Intervention, Video, Narrative, 10-043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Mount Sinai Hospital, New York
- Study start
- Apr 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiopulmonary resuscitation (CPR) video | – | Behavioral: (CPR) video and questionnairesThis 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. |
| cardiopulmonary resuscitation (CPR) narrative script | – | Behavioral: cardiopulmonary resuscitation (CPR) narrative script and questionnairesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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*
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (CPR) video and questionnairesBaseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months) | Behavioural | cardiopulmonary resuscitation (CPR) video |
| cardiopulmonary resuscitation (CPR) narrative script and questionnairesBaseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months) | Behavioural | cardiopulmonary resuscitation (CPR) narrative script |
Primary outcome
To document advance directive (AD)completion
Time frame: 1 month post-test
2 secondary outcomes
To assess patient uncertainty about, knowledge of, and preference for CPR.
Time frame: pre and post randomization
To longitudinally follow discussions about ADs and nature of hospitalizations
Time frame: 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen O'Reilly, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas and Hepatobiliary Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To document advance directive (AD)completion (time frame: 1 month post-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.