Assessment Of A Serious Illness Conversation Guide (SICG) In Advanced Gastro-Intestinal Cancers

Study Overview

Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers

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.

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.

Gastrointestinal Cancer
Colorectal Cancer
Pancreatic Adenocarcinoma
Gastric Cancer
Esophageal Cancer
Cholangiocarcinoma
Hepatocellular Carcinoma
Neuroendocrine Tumors
GIST, Malignant

BEHAVIORAL: Serious Illness Conversation Guide (SICG)
BEHAVIORAL: Quality of Life (QOL) survey

IRB-51256
VAR0179 (OTHER Identifier) (OTHER: OnCore)
IRB-51256 (OTHER Identifier) (OTHER: Stanford IRB)
NCI-2019-07235 (OTHER Identifier) (OTHER: NCI Trial Identifier)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-08-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-01-25
First Submitted that Met QC Criteria 2019-09-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-01-27
First Posted (ACTUAL) 2019-09-04	Results First Posted N/A	Last Verified 2022-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Serious illness conversation guide (SICG) Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.	BEHAVIORAL: Serious Illness Conversation Guide (SICG) The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients. BEHAVIORAL: Quality of Life (QOL) survey Quality of life survey by questionnaire (FACT-G) given every three months
ACTIVE_COMPARATOR: Conversations by treating team Patients have conversations as determined by treating team (but not using SICG tool).	BEHAVIORAL: Quality of Life (QOL) survey Quality of life survey by questionnaire (FACT-G) given every three months

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Serious illness conversation guide (SICG)

Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.

BEHAVIORAL: Serious Illness Conversation Guide (SICG)

The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients.

BEHAVIORAL: Quality of Life (QOL) survey

Quality of life survey by questionnaire (FACT-G) given every three months

ACTIVE_COMPARATOR: Conversations by treating team

Patients have conversations as determined by treating team (but not using SICG tool).

BEHAVIORAL: Quality of Life (QOL) survey

Quality of life survey by questionnaire (FACT-G) given every three months

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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

Any patient not meeting the above criteria
Non-English speaking patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Tyler P Johnson, MD, Stanford University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record