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

Advanced Gastrointestinal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912131
• Other study ID #: 13-120
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: January 2020

Study information

• Verified date: January 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• single pilot interview
Part 1 participants will be scheduled for their single pilot interview. There are no additional assessments.
• goals-of-care (GOC) video
Subjects will be shown the goals-of-care (GOC) video but not undergo a narrative interview process - they will be contacted as per re-assessment.
• goals-of-care (GOC) video and narrative question
subjects will watch the goals-of-care (GOC) video (described in detail in the next paragraph) and then be given the narrative question stem vetted/assessed in part 1 including any changes made to that stem in the process of Part 1 testing. Subjects in P-COCC arm will then be contacted for a telephone interview and audio-taping of their narrative. Interviews will be semi- structured and based off the narrative stem that subjects were previously given for review. Interviews will last approximately 30-45 minutes and will be conducted by staff from the MSKCC Department of Psychiatry & Behavioral Sciences,
• usual care
Subjects in the usual care arm will neither be given the narrative stem nor watch the video.
• Part 2
Will be a proof-of-concept, small scale, RCT to measure P-COCC acceptability and other quantitative and qualitative effects. Seventy five participants will be randomized to Usual Care, Video, or Video and Interview.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the acceptability of this piloted P-COCC intervention	primary outcome is assessed in Part 2 of the study, and is acceptability of this newly- developed P-COCC intervention, as measured by subjects in P-COCC arm who will complete three Likert scale questions examining the degree to which they found the narrative recording process.	2 years
Secondary	quantitative analyses	pre-post scoring on our various psychometric questionnaires (quantitative) and of the subject responses during narrative interviewing (qualitative)	2 years
Secondary	qualitative analyses	pre-post scoring on our various psychometric questionnaires (quantitative) and of the subject responses during narrative interviewing (qualitative)	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center