Skip to content

Serious Illness Communication Project

Serious Illness Communication Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01786811
Enrollment
994
Registered
2013-02-08
Start date
2012-06-30
Completion date
2016-06-30
Last updated
2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, End of Life Care

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.

Interventions

BEHAVIORALTraining

1. 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. 2. 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.

Sponsors

Partners HealthCare
CollaboratorOTHER
Charina Endowment Fund
CollaboratorUNKNOWN
Margaret T. Morris Foundation
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Enhanced goal-consistent careup to 2 yearsPatients 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.
PEACEup to 2 yearsPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026