Back to resultsAssessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
Primary Purpose
Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serious Illness Conversation Guide (SICG)
Quality of Life (QOL) survey
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
- Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
- Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
- Patients with metastatic pancreatic adenocarcinoma.
- Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
- Patients with metastatic cholangiocarcinoma whose tumor has progressed through first-line chemotherapy of any type.
- Patients with metastatic hepatocellular carcinoma whose tumor has progressed through PD1 blockade.
- Patients with metastatic high-grade neuroendocrine tumor.
- A patient with a metastatic GIST that has progressed through first-line tyrosine kinase inhibitor.
- Expected life expectancy of at least one month
Exclusion Criteria:
- Any patient not meeting the above criteria
- Non-English speaking patients
Sites / Locations
- Stanford Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Serious illness conversation guide (SICG)
Conversations by treating team
Arm Description
Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.
Patients have conversations as determined by treating team (but not using SICG tool).
Outcomes
Primary Outcome Measures
Difference in proportions of patients with documented goals of care
Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms
Secondary Outcome Measures
Difference in proportions of patients with appropriate care toward end of life
Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed.
Comparison of QOL survey measures by section
Comparison of survey QOL measures by section for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Overall comparison of QOL survey
Comparison of survey QOL measures overall for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04077372
Brief Title
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
Official Title
A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
October 11, 2020 (Actual)
Study Completion Date
October 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.
Detailed Description
Primary Objective: To determine whether the Serious Illness Conversation Guide will improve the consistency with which providers have and document conversations regarding patients' goals and priorities as they near the end of life.
Secondary Objectives: 1. To assess whether having conversations as per this model will improve the quality of care near the end of life as determined by appropriate care in concordance with their goals of care.
2. To assess whether having conversations as per this model will improve patient Quality of Life (QOL) as per a validated scale.
3. To assess in patients with concordant care whether this model will improve patient QOL as per a validated scale 4. To assess provider opinions about end-of-life conversations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Hepatocellular Carcinoma, Neuroendocrine Tumors, GIST, Malignant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serious illness conversation guide (SICG)
Arm Type
Experimental
Arm Description
Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.
Arm Title
Conversations by treating team
Arm Type
Active Comparator
Arm Description
Patients have conversations as determined by treating team (but not using SICG tool).
Intervention Type
Behavioral
Intervention Name(s)
Serious Illness Conversation Guide (SICG)
Intervention Description
The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients.
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life (QOL) survey
Intervention Description
Quality of life survey by questionnaire (FACT-G) given every three months
Primary Outcome Measure Information:
Title
Difference in proportions of patients with documented goals of care
Description
Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Difference in proportions of patients with appropriate care toward end of life
Description
Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed.
Time Frame
1 year
Title
Comparison of QOL survey measures by section
Description
Comparison of survey QOL measures by section for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Time Frame
1 year
Title
Overall comparison of QOL survey
Description
Comparison of survey QOL measures overall for control and intervention arms will be done by Functional Assessment of Cancer Therapy (FACT-G) , version 4 scale. It is a 28-item validated QoL questionnaire in patients receiving cancer treatment. All subscales are summed together to arrive at a total score. A higher point value is considered a better quality of life score
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metastatic colorectal cancer whose tumor has progressed on both FOLFOX and FOLFIRI.
Exception: Patients with metastatic colorectal cancer whose tumors demonstrate a BRAF V600E mutation may be enrolled regardless of prior chemotherapy.
Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies mentioned above.
Patients with metastatic pancreatic adenocarcinoma.
Patients with metastatic gastric or esophageal cancer whose tumor has progressed through first-line chemotherapy of any type.
Patients with metastatic cholangiocarcinoma whose tumor has progressed through first-line chemotherapy of any type.
Patients with metastatic hepatocellular carcinoma whose tumor has progressed through PD1 blockade.
Patients with metastatic high-grade neuroendocrine tumor.
A patient with a metastatic GIST that has progressed through first-line tyrosine kinase inhibitor.
Expected life expectancy of at least one month
Exclusion Criteria:
Any patient not meeting the above criteria
Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler P Johnson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
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