Serious Illness Communication Project

Not Applicable

Completed

• Conditions: End of Life Care; Cancer
• Interventions: Behavioral: Training

• Registration Number: NCT01786811
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of the study is to evaluate the impact of implementing a "Serious Illness Conversation Guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. The goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. We hypothesize that patients whose physician is trained to use and adheres to the elements of the Serious Illness Conversation Guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 994

Inclusion Criteria

1. Dana-Farber Cancer Institute medical oncology clinician
2. Care for patients with selected high-risk cancers

Clinician

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Exclusion Criteria

1. DFCI Gynecology-Oncology specialist
2. Seeing patients only in the Phase I clinical trial disease center

Patient Inclusion Criteria

1. Over 18 years of age
2. English speaker
3. Patient at Dana-Farber Cancer Institute, including satellite sites at Milford Regional Medical Center and South Shore Hospital
4. Diagnosis of one of the following high mortality or advanced cancers: breast, gastric, intestinal, esophageal, pancreatic, biliary, colorectal, hepatocellular, head and neck, renal, bladder, prostate, acute myeloid lymphoma (AML), acute lymphoblastic lymphoma (ALL), lymphoma, melanoma, glioblastoma multiforme (GBM), sarcoma, and lung.
5. Ability to provide consent

Patient Exclusion Criteria

1. Diagnosis of advanced obstetric-gynecological cancer
2. Cognitive impairment

Family Member Inclusion Criteria

1. Over 18 years of age
2. English speaker
3. Friend or family member of study patient (Health care proxy, or close friend or family member who is involved in helping the patient think about decisions related to their health care)
4. Ability to provide consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trained Clinicians	Training	Clinicians randomized into this group will receive training in using the Serious Illness Conversation Guide with their patients. Patients of these clinicians will also be in the intervention arm.

Primary Outcome Measures

Name	Time	Method
PEACE	up to 2 years	Patients whose physician is trained to use and adheres to the SICG will be more likely to report being at peace in the final 3 months of life than patients whose physician is not trained to use the SICG. Being at peace will be measured by the PEACE scale, a 13-item validated questionnaire in cancer patients.
Enhanced goal-consistent care	up to 2 years	Patients whose physician is trained to use and adheres to the SICG will receive care that is more consistent with their key life priorities during the last week and the last 3 months of life than patients whose physician is not trained to use the SICG. Goal consistent care will be measured by comparing goals identified by the patient during the final 3 months and final week of life, to care received by the patient, which will be measured by chart review and family report. For each priority/goal listed by the patient as important, we will give a score from 0 to 3 to quantify the extent to which that goal was achieved by the patient. Higher overall score will show more goal-consistent care.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States