Improving Goals of Care Discussion in Advanced Cancer Patients
Primary Purpose
Primary Stage IV Hepatobiliary, Esophageal, Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GoC intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Stage IV Hepatobiliary focused on measuring Advanced cancer, goals of care, quality of care, end of life discussions
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.
Sites / Locations
- Smilow Cancer Hospital, Yale Cancer Center, Yale University
- Mount Sinai Beth Israel
- Icahn School of Medicine at Mount Sinai
- Kings County Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GoC intervention
Usual Care
Arm Description
Oncologists trained using OncoTalk to have Goals of Care discussions.
Outcomes
Primary Outcome Measures
Number of Participants Who Perceived Increased Goals of Care Discussions
Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.
Number of Patients Perception of Improved Goals of Care Discussions
Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.
Secondary Outcome Measures
Communication Skills Training
Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.
Full Information
NCT ID
NCT02374255
First Posted
February 9, 2015
Last Updated
September 6, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02374255
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GoC intervention
Arm Type
Experimental
Arm Description
Oncologists trained using OncoTalk to have Goals of Care discussions.
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
GoC intervention
Other Intervention Name(s)
Goals of Care discussions
Intervention Description
Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.
Primary Outcome Measure Information:
Title
Number of Participants Who Perceived Increased Goals of Care Discussions
Description
Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.
Time Frame
up to 6 months
Title
Number of Patients Perception of Improved Goals of Care Discussions
Description
Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Communication Skills Training
Description
Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Bickell, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Cancer Hospital, Yale Cancer Center, Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Kings County Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
11203
Country
United States
12. IPD Sharing Statement
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Improving Goals of Care Discussion in Advanced Cancer Patients
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