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| ID | Type | Description | Link |
|---|---|---|---|
| VAR0179 | Other Identifier | OnCore | |
| IRB-51256 | Other Identifier | Stanford IRB | |
| NCI-2019-07235 | Other Identifier | NCI Trial Identifier |
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Covid-19
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serious illness conversation guide (SICG) | Experimental | Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter. |
|
| Conversations by treating team | Active Comparator | Patients have conversations as determined by treating team (but not using SICG tool). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serious Illness Conversation Guide (SICG) | Behavioral | The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportions of patients with documented goals of care | Difference in proportions of patients who have documented goals of care in medical records, assessed after death, for both arms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportions of patients with appropriate care toward end of life | Proportion of patients receiving appropriate care in line with their goals of care toward the end of life, by arm will be assessed. | 1 year |
| Comparison of QOL survey measures by section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyler P Johnson, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94304 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2019 | Jan 25, 2023 |
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| Quality of Life (QOL) survey | Behavioral | Quality of life survey by questionnaire (FACT-G) given every three months |
|
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 |
| 1 year |
| Overall comparison of QOL survey | 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 | 1 year |
| ICF_001.pdf |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D018281 | Cholangiocarcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D018358 | Neuroendocrine Tumors |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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