Cholangiocarcinoma, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Gastrointestinal Cancer, GIST, Malignant, Hepatocellular Carcinoma, Neuroendocrine Tumors, Pancreatic Adenocarcinoma
Conditions
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.
Interventions
BEHAVIORALSerious 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.
BEHAVIORALQuality of Life (QOL) survey
Quality of life survey by questionnaire (FACT-G) given every three months
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed