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

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.

Conditions

• Advanced Gastrointestinal Cancer

Interventions

BEHAVIORAL

single pilot interview

Part 1 participants will be scheduled for their single pilot interview. There are no additional assessments.

BEHAVIORAL

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.

BEHAVIORAL

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,

BEHAVIORAL

usual care

Subjects in the usual care arm will neither be given the narrative stem nor watch the video.

BEHAVIORAL

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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Andrew Epstein, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2020-01-31

Completion

2020-01-31

Countries

• United States

Study Locations