Clinical trial NCT04077372: 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
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Cancer
Colorectal Cancer
Pancreatic Adenocarcinoma
Gastric Cancer
Esophageal Cancer
Cholangiocarcinoma
Hepatocellular Carcinoma
Neuroendocrine Tumors
GIST, Malignant
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in proportions of patients with documented goals of care
timeFrame: 1 year
Secondary outcomes:
measure: Difference in proportions of patients with appropriate care toward end of life
timeFrame: 1 year
measure: Comparison of QOL survey measures by section
timeFrame: 1 year
measure: Overall comparison of QOL survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Tyler P Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: