Improving Goals of Care Discussion in Advanced Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374255
• Other study ID #: GCO 14-0082
• Status: Completed
• Phase: N/A
• Start date: March 15, 2016
• Est. completion date: May 16, 2018

Study information

• Verified date: September 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Cancer of Stomach
• Colorectal Cancer
• Esophageal
• Glioblastoma
• Head or Neck Cancer
• Lung Cancers
• Melanoma
• Pancreatic Cancers
• Pancreatic Neoplasms
• Primary Stage IV Hepatobiliary
• Stage III
• Stage IV
• Stomach Neoplasms

Intervention

Behavioral:
• GoC intervention
Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Locations

Country	Name	City	State
United States	Smilow Cancer Hospital, Yale Cancer Center, Yale University	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Kings County Hospital Center	New York	New York
United States	Mount Sinai Beth Israel	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 months
Primary	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.	up to 6 months
Secondary	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.	up to 6 months