Serious Illness Communication Project
This trial is active, not recruiting.
|Conditions||end of life care, cancer|
|Sponsor||Dana-Farber Cancer Institute|
|Start date||June 2012|
|End date||June 2016|
|Trial size||994 participants|
|Trial identifier||NCT01786811, 12-027|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
Enhanced goal-consistent care
time frame: up to 2 years
time frame: up to 2 years
Male or female participants at least 18 years old.
The subjects of this study will be the clinicians (physicians and nurse practitioners) conducting the SICG conversations, their patient with high-risk cancers, and a friend or family member of the patient. Clinician Inclusion Criteria: 1. Dana-Farber Cancer Institute medical oncology clinician 2. Care for patients with selected high-risk cancers Clinician 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
|Official title||Serious Illness Communication Project|
|Principal investigator||Rachelle Bernacki, MD, MS|
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