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

A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With 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.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Carcinoma; Gastric Cancer; Colorectal Cancer; Esophageal Cancer; Pancreatic Adenocarcinoma; Neuroendocrine Tumors; Cholangiocarcinoma; Gastrointestinal Cancer; GIST, Malignant
• Intervention / Treatment: Behavioral: Serious Illness Conversation Guide (SICG); Behavioral: Quality of Life (QOL) survey

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Tyler P Johnson, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): October 11, 2020
• Study Completion (Actual): October 11, 2020

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Gastrointestinal Neoplasms; Cholangiocarcinoma; Neuroendocrine Tumors; Intestinal Neoplasms
• Other Study ID Numbers: IRB-51256 (Other Identifier: Stanford IRB); VAR0179 (Other Identifier: OnCore); NCI-2019-07235 (Other Identifier: NCI Trial Identifier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No