Clinical trial · Interventional
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
A Randomized, Controlled Trial Examining the Use of The "Serious Illness Conversation Guide" (SICG) in Patients With Advanced Gastro-Intestinal Cancers
NCT04077372CI-TRIAL-00063503terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid-19
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| GIST, Malignant | Malignant Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of Life (QOL) survey | Behavioral | — | UNRESOLVED |
| Serious Illness Conversation Guide (SICG) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Serious illness conversation guide (SICG)
- description
- Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.
- interventionNames
- Behavioral: Serious Illness Conversation Guide (SICG)
- Behavioral: Quality of Life (QOL) survey
- type
- ACTIVE_COMPARATOR
- label
- Conversations by treating team
- description
- Patients have conversations as determined by treating team (but not using SICG tool).
- interventionNames
- Behavioral: Quality of Life (QOL) survey
Primary outcomes (1)
- measure
- Difference in proportions of patients with documented goals of care
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.