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Completed

NCT Number: NCT02374255

Improving Goals of Care Discussion in Advanced Cancer Patients

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.

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Key information

Conditions

Primary Stage IV Hepatobiliary Astrocytoma Cancer of Pancreas Cancer of Stomach Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Gastrointestinal Diseases Gastrointestinal Neoplasms Glioblastoma Glioma Head and Neck Neoplasms Head or Neck Cancer Intestinal Diseases Intestinal Neoplasms Lung Cancers Lung Diseases Lung Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Cancers Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stage III Stage IV Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smilow Cancer Hospital, Yale Cancer Center, Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GoC intervention

Behavioral

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

Other names: Goals of Care discussions

Primary outcomes

  1. Number of Participants Who Perceived Increased Goals of Care Discussions

    Time frame: up to 6 months

    Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

  2. Number of Patients Perception of Improved Goals of Care Discussions

    Time frame: up to 6 months

    Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.

Secondary outcomes

  1. Communication Skills Training

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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