Improving Goals of Care Discussion in Advanced Cancer Patients

NCT02374255 | Completed Results

• 1 other identifier: GCO 14-0082
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Communication Skills Training

  up to 6 months

Study Arms (2)

GoC intervention

EXPERIMENTAL

Oncologists trained using OncoTalk to have Goals of Care discussions.

Behavioral: GoC intervention

Usual Care

NO INTERVENTION

Interventions

GoC intervention BEHAVIORAL

Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Also known as: Goals of Care discussions

GoC intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

Smilow Cancer Hospital, Yale Cancer Center, Yale University

New Haven, Connecticut, 06510, United States

Location

Mount Sinai Beth Israel

New York, New York, 10011, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Kings County Hospital Center

New York, New York, 11203, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Glioblastoma; Stomach Neoplasms; Pancreatic Neoplasms; Melanoma; Head and Neck Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Radhi Yagnik
• Organization: Icahn School of Medicine at Mount Sinai

radhi.yagnik@mountsinai.org

212-659-5933

Study Officials

• Nina Bickell, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 27, 2015
• Study Start: March 15, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Locations

US (4)