Clinical trial NCT01912131: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Gastrointestinal Cancer
Keywords: 13-120
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: assess the acceptability of this piloted P-COCC intervention
timeFrame: 2 years
Secondary outcomes:
measure: quantitative analyses
timeFrame: 2 years
measure: qualitative analyses
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References: