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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04077372
• Other study ID #: IRB-51256
• Secondary ID: VAR0179IRB-51256
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: October 11, 2020

Study information

• Verified date: April 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

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.
• Quality of Life (QOL) survey
Quality of life survey by questionnaire (FACT-G) given every three months

Locations

Country	Name	City	State
United States	Stanford Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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