Colorectal Cancer Clinical Trial
Official title:
A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
Verified date | April 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | October 11, 2020 |
Est. primary completion date | October 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Cancer Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year |
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