Advanced Gastrointestinal CancerNCT01912131
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
A study testing single pilot interview, goals-of-care (GOC) video and goals-of-care (GOC) video and narrative question in people with Advanced Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Cancer
- What is being tested?
- single pilot interview, goals-of-care (GOC) video and goals-of-care (GOC) video and narrative question
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
- Being tested
- single pilot interview, goals-of-care (GOC) video, goals-of-care (GOC) video and narrative question, usual care, Part 2
- Keywords
- 13-120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single pilot interviewBehavioural
Part 1 participants will be scheduled for their single pilot interview. There are no additional assessments.
goals-of-care (GOC) videoBehavioural
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 questionBehavioural
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 careBehavioural
Subjects in the usual care arm will neither be given the narrative stem nor watch the video.
Part 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| First 24 patients Cognitive interviewing | Experimental | 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. Receives: Behavioral: single pilot interview |
| usual care | Active comparator | 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. Receives: Behavioral: usual care; Behavioral: Part 2 |
| video-only arm | Experimental | 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. Receives: Behavioral: goals-of-care (GOC) video; Behavioral: Part 2 |
| combined narrative and video (P-COCC) arm | Experimental | 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. Receives: Behavioral: goals-of-care (GOC) video and narrative question; Behavioral: Part 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
quantitative analyses
pre-post scoring on our various psychometric questionnaires (quantitative) and of the subject responses during narrative interviewing (qualitative)
Measured: 2 years
qualitative analyses
pre-post scoring on our various psychometric questionnaires (quantitative) and of the subject responses during narrative interviewing (qualitative)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Epstein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912131
- Sponsor's protocol ID
- 13-120
- Status last verified
- Jan 2020
- First submitted
- 25 Jul 2013
- Last updated
- 22 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01912131
- Acronym / sponsor ID
- 13-120
- Conditions
- Advanced Gastrointestinal Cancer
- Keywords
- 13-120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First 24 patients Cognitive interviewing | Experimental | Behavioral: single pilot interviewPart 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. |
| usual care | Active comparator | Behavioral: usual care, Behavioral: Part 2As 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. |
| video-only arm | Experimental | Behavioral: goals-of-care (GOC) video, Behavioral: Part 2As 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. |
| combined narrative and video (P-COCC) arm | Experimental | Behavioral: goals-of-care (GOC) video and narrative question, Behavioral: Part 2As 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single pilot interviewPart 1 participants will be scheduled for their single pilot interview. There are no additional assessments. | Behavioural | First 24 patients Cognitive interviewing |
| goals-of-care (GOC) videoSubjects will be shown the goals-of-care (GOC) video but not undergo a narrative interview process - they will be contacted as per re-assessment. | Behavioural | video-only arm |
| goals-of-care (GOC) video and narrative questionsubjects 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, | Behavioural | combined narrative and video (P-COCC) arm |
| usual careSubjects in the usual care arm will neither be given the narrative stem nor watch the video. | Behavioural | usual care |
| Part 2Will 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. | Behavioural | combined narrative and video (P-COCC) arm, usual care, video-only arm |
Primary outcome
assess the acceptability of this piloted P-COCC intervention
Time frame: 2 years
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 secondary outcomes
quantitative analyses
Time frame: 2 years
qualitative analyses
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Epstein, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single pilot interview, goals-of-care (GOC) video and goals-of-care (GOC) video and narrative question in people with Advanced Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the acceptability of this piloted P-COCC intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.