Person-Centered Oncology Care and Choices (P-COCC): Piloting and Initial Randomized Testing of a Combined Values Narrative Interview and Video Education Advance Care Planning Program in Gastrointestinal Oncology Patients
Completed · Not applicable
Conditions studied: Advanced Gastrointestinal Cancer
In brief
This study is being done to get individuals' feedback on advanced care planning and decision making. This study is divided into two parts (Part 1 and Part 2). The purpose of Part 1 is to survey people to find out what is important to people with advanced cancer (again, their values, such as their goals, concerns and sources of support). This has never been done before in the way the investigators are doing it, and that is why this is called a "pilot" study, which is where a new method or treatment is being created and evaluated. The purpose of Part 2 is to see if combining a medical options video with a short interview about values helps people with how they feel about their medical situation, and what they know about their medical options for their medical situation.
Key facts
- Study ID
- NCT01912131
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 178
- Starts
- 2013-07-01
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2020-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to speak, read and understand English well enough to complete study assessments and interviews in the judgement of the consenting professional
- 18 years of age and older
- Be seen regularly (at least monthly) at an MSKCC GI medical oncology clinic
- Has an exocrine GI cancer with MSKCC pathology confirmation at the primary or metastatic anatomic site
- Non-metastatic GI cancers are eligible only if the Eastern Cooperative Oncology Group (ECOG) performance status54 is 2,3, or 4 at the time of consent (although patients with locally advanced [stage III] and inoperable pancreatic cancers are eligible regardless of their performance status)
- Has a metastatic neuroendocrine histology with MSKCC pathology confirmation as moderately or poorly differentiated or intermediate or high grade
- A referring physician's estimate of patient life expectancy must be between 1-12 months. We use this life expectancy range in order to ensure some degree of subject homogeneity for the purpose of sample size and methodologic design. Also, these timeframes were chosen in order to test an intervention in patients with serious illness (under 1 year prognosis).
- Part 2 Only: Did not complete Part 1 of the study.
You may not qualify if…
- Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental functioning" (3 or more errors).
- Significant psychiatric or cognitive disturbance sufficient, in the consenting professional's or investigator's judgment, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment).
Where it is running
- Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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