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
NCT ID: NCT01912131
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
178 participants
INTERVENTIONAL
2013-07-31
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing
NCT03180411
Patients Navigator for Organized Colorectal Cancer Screening
NCT02369757
Person-Centred Information and Communication for Patients Undergoing Colo-Rectal Surgery - the PINCORE Project
NCT03587818
Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information
NCT01003600
QoLiCOL - Quality of Life in Colon Cancer
NCT02530593
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
First 24 patients Cognitive interviewing
Part 1 - This first study phase will involve interviewing 24 patients to ask for their feedback on the appropriateness of questions being developed for use in the narrative interviewing in part 2 of the study. The cognitive interview will be audio-recorded. Demographics and ECOG performance status will be recorded prior to the cognitive interview.
single pilot interview
Part 1 participants will be scheduled for their single pilot interview. There are no additional assessments.
usual care
As outlined ECOG performance status will be recorded at the time of registration without the subject's involvement. Quality of life, treatment satisfaction, distress and peacefulness will also be recorded at baseline. Subjects will neither be shown the goals-of-care (GOC) video nor undergo the narrative interview process - they will be contacted as per re-assessment.
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.
video-only arm
As outlined ECOG performance status will be recorded at the time of registration without the subject's involvement. Quality of life, treatment satisfaction, distress and peacefulness will also be recorded at baseline. 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
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.
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.
combined narrative and video (P-COCC) arm
As outlined ECOG performance status will be recorded at the time of registration without the subject's involvement. Quality of life, treatment satisfaction, distress and peacefulness will also be recorded at baseline. 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.
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,
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Epstein, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan-Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13-120
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.