NCT04077372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2020

Completed
Last Updated

January 27, 2023

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

August 30, 2019

Last Update Submit

January 25, 2023

Conditions

Gastrointestinal CancerColorectal CancerPancreatic AdenocarcinomaGastric CancerEsophageal CancerCholangiocarcinomaHepatocellular CarcinomaNeuroendocrine TumorsGIST, Malignant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Difference in proportions of patients with appropriate care toward end of life

    1 year

  • Comparison of QOL survey measures by section

    1 year

  • Overall comparison of QOL survey

    1 year

Study Arms (2)

Serious illness conversation guide (SICG)

EXPERIMENTAL

Patients have "serious illness conversation" within 3 wks of randomization and every 3 months thereafter.

Behavioral: Serious Illness Conversation Guide (SICG)Behavioral: Quality of Life (QOL) survey

Conversations by treating team

ACTIVE COMPARATOR

Patients have conversations as determined by treating team (but not using SICG tool).

Behavioral: Quality of Life (QOL) survey

Interventions

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.

Serious illness conversation guide (SICG)
Quality of Life (QOL) surveyBEHAVIORAL

Quality of life survey by questionnaire (FACT-G) given every three months

Conversations by treating teamSerious illness conversation guide (SICG)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any patient not meeting the above criteria
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Cancer Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsColorectal NeoplasmsStomach NeoplasmsEsophageal NeoplasmsCholangiocarcinomaCarcinoma, HepatocellularNeuroendocrine TumorsGastrointestinal Stromal Tumors

Interventions

Quality of LifeSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Tyler P Johnson, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 4, 2019

Study Start

September 16, 2019

Primary Completion

October 11, 2020

Study Completion

October 11, 2020

Last Updated

January 27, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)