Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
NCT ID: NCT04077372
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2019-09-16
2020-10-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Serious illness conversation guide (SICG)
Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.
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
Conversations by treating team
Patients have conversations as determined by treating team (but not using SICG tool).
Quality of Life (QOL) survey
Quality of life survey by questionnaire (FACT-G) given every three months
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Non-English speaking patients
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Tyler P Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Cancer Center
Stanford, California, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VAR0179
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-51256
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2019-07235
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-51256
Identifier Type: -
Identifier Source: org_study_id
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