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

Stanford University

Status: Terminated

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

Treatments: Behavioral: Serious Illness Conversation Guide (SICG); Behavioral: Quality of Life (QOL) survey

Study type: Interventional

Funder types: Other

Identifiers

NCT04077372

IRB-51256 (Other Identifier)

NCI-2019-07235 (Other Identifier)

VAR0179 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Serious illness conversation guide (SICG)

Experimental group

Description:

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

Treatment:

Behavioral: Serious Illness Conversation Guide (SICG)

Behavioral: Quality of Life (QOL) survey

Conversations by treating team

Active Comparator group

Description:

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

Treatment:

Behavioral: Quality of Life (QOL) survey