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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077372
Recruitment Status : Suspended (Covid-19)
First Posted : September 4, 2019
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Colorectal Cancer Pancreatic Adenocarcinoma Gastric Cancer Esophageal Cancer Cholangiocarcinoma Hepatocellular Carcinoma Neuroendocrine Tumors GIST, Malignant Behavioral: Serious Illness Conversation Guide (SICG) Behavioral: Quality of Life (QOL) survey Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : September 2022


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




Primary Outcome Measures :
  1. Difference in proportions of patients with documented goals of care [ Time Frame: 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 :
  1. Difference in proportions of patients with appropriate care toward end of life [ Time Frame: 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.

  2. Comparison of QOL survey measures by section [ Time Frame: 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

  3. Overall comparison of QOL survey [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077372


Locations
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United States, California
Stanford Cancer Center
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Tyler P Johnson, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04077372    
Other Study ID Numbers: IRB-51256
VAR0179 ( Other Identifier: OnCore )
IRB-51256 ( Other Identifier: Stanford IRB )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neuroendocrine Tumors
Cholangiocarcinoma
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue