Clinical trial NCT02374255: Improving Goals of Care Discussion in Advanced Cancer Patients
Official title: Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Stage IV Hepatobiliary
Esophageal
Colorectal Cancer
Glioblastoma
Cancer of Stomach
Cancer of Pancreas
Melanoma
Head or Neck Cancer
Stage III
Stage IV
Lung Cancers
Pancreatic Cancers
Keywords: Advanced cancer
goals of care
quality of care
end of life discussions
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-27
Enrollment: 265
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.

Detailed description: Among advanced cancer patients, discussions about prognosis, goals of care (GoC) and end-of-life preferences improve quality of life of patients and reduce rates of hospital and ICU admission. Yet, few patients know their chemotherapy treatments will not cure their disease despite nearly all wishing to receive information- good \& bad. Currently, 37% of advanced cancer patients have GoC clarifying discussions and when they do, it is often in the last 2 months of life when symptoms are uncontrollable and oncologists have no other treatments to offer. These discussions do not usually happen with the patient's personal oncologist. Current efforts to teach oncologists such skills are impractical, requiring a lot of time away from their office practice and do not take into account job pressures.

The goal of this study is to increase and improve GoC discussions for advanced cancer patients by training medical oncologists to conduct these discussions and evaluate its effects on patient satisfaction, receipt of care in line with preferences, aggressive care utilization, and oncologist communication skill.

The investigators will recruit 280 patients of which half will come from intervention doctors and the other from the control doctors. The investigators will train randomly selected oncologists to conduct GoC discussion. Patients will be surveyed at baseline within days of their GOC visit and at 6 months. Oncologists will be audio-taped at baseline and after training is complete to assess practice and skill to conduct GoC discussions.

Primary outcomes include patient reported conduct of and satisfaction with GoC discussion. Secondary outcomes include oncologist communication skills, feasibility of performing GoC in the outpatient setting, receipt of care in line with preferences, use of hospice, chemotherapy or ICU in the last 30 days of life.

Eligibility criteria: Inclusion Criteria:

* Men or women who are at least 21 years of age who have been diagnosed within one month with a pathologically confirmed advanced cancer who have an average of \<2 y life expectancy (primary stage IV hepatobiliary, esophageal, colorectal, glioblastoma, gastric, pancreatic, melanoma, head \& neck, or stage III or IV lung or pancreatic cancers) and are being treated at one of the participating hospital sites and speak English or Spanish.
* Oncologists who treat at least 2 advanced cancer patients per month at a study participating hospital will be enrolled into the study.

Exclusion Criteria:

* Patients who have seen an oncologist after undergoing first line treatment imaging as this group has a higher likelihood of having received a goals of care discussion.
* Men or women who do not speak English or Spanish will be excluded.

Primary outcomes:
measure: Number of Participants Who Perceived Increased Goals of Care Discussions
timeFrame: up to 6 months
measure: Number of Patients Perception of Improved Goals of Care Discussions
timeFrame: up to 6 months
Secondary outcomes:
measure: Communication Skills Training
timeFrame: up to 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Hospital, Yale Cancer Center, Yale University
state: Connecticut
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Kings County Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nina Bickell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: