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

Not Applicable

Terminated

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

• Registration Number: NCT04077372
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-04
• Study Start: 2019-09-16
• Primary Completion: 2020-10-11
• Study Completion: 2020-10-11
• Status Verified: 2022-04
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conversations by treating team	Quality of Life (QOL) survey	Patients have conversations as determined by treating team (but not using SICG tool).
Serious illness conversation guide (SICG)	Quality of Life (QOL) survey	Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.
Serious illness conversation guide (SICG)	Serious Illness Conversation Guide (SICG)	Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.

Primary Outcome Measures

Name	Time	Method
Difference in proportions of patients with documented goals of care	1 year	Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms

Secondary Outcome Measures

Name	Time	Method
Difference in proportions of patients with appropriate care toward end of life	1 year	Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed.
Overall comparison of QOL survey	1 year	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
Comparison of QOL survey measures by section	1 year	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

Trial Locations

Locations (1)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States