This trial is active, not recruiting.

Conditions end of life care, cancer
Treatment training
Sponsor Dana-Farber Cancer Institute
Collaborator Partners HealthCare
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
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.
Initial Training: The training program for clinicians randomized into the intervention arm will be 2.5 hours. The project will be introduced and the Serious Illness Conversation Guide shared. The training session will include a brief didactic session on "Challenges in discussing advance care planning/values and goals" followed by practice using the SICG. Coaching and Feedback: We will also provide individual coaching for clinicians. Clinicians will be able to contact the study doctor to request coaching/debriefing on a challenging case; one of the investigators will respond within 24-48 hours for urgent or distressing cases (up to 72 hours on weekends). In-the-moment coaching will be by telephone or in person.
(No Intervention)
Clinicians randomized into this group will not receive training in using the Serious Illness Conversation Guide with their patients. They will provide usual care. Patients of these clinicians will also be in the control arm.
(No Intervention)
These clinicians do not agree to participate in the study. They will continue to provide usual care. Their patients will be invited to participate and be followed.

Primary Outcomes

Enhanced goal-consistent care
time frame: up to 2 years
time frame: up to 2 years

Eligibility Criteria

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

Additional Information

Official title Serious Illness Communication Project
Principal investigator Rachelle Bernacki, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.