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Goals of Care Discussions for Hospitalized Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991015
First Posted: November 25, 2013
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Rashmi Sharma, Northwestern University
  Purpose
The goal of this study is to better understand gender differences in end-of-life communication between physicians and patients with advanced cancer in the hospital.

Condition
Metastatic Cancer

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Gender Differences in Inpatient Goals of Care Discussions in Patients With Advanced Cancer

Further study details as provided by Rashmi Sharma, Northwestern University:

Primary Outcome Measures:
  • Quality of end-of-life communication [ Time Frame: 15 months ]
    This is a qualitative study and the outcome will be assessed by coding the transcripts of the goals of care discussions. We will use the Roter Interaction Analysis System (RIAS) in which coders assign 1 of 37 mutually exclusive and exhaustive categories to each complete thought expressed (referred to as an utterance). Utterances are combined to reflect "instrumental" (e.g., biomedical exchange, psychosocial exchange, and partnership building) and "affective" behaviors (e.g., social conversation, positive and negative statements, and emotional statements). Additional global measures include patient-centeredness, verbal dominance, and tone.


Enrollment: 43
Study Start Date: November 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must be hospitalized at Northwestern Memorial Hospital and be having a goals of care discussion with their physician. In addition, eligible patients must be greater than the age of 18 years, speak English fluently, be able to physically and cognitively complete the informed consent process, and have metastatic cancer that has progressed despite treatment.
Criteria

Inclusion Criteria:

  • English speaking, have metastatic cancer that has progressed despite treatment

Exclusion Criteria:

  • Cognitive impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991015


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Rashmi K Sharma, MD, MHS Northwestern University
  More Information

Responsible Party: Rashmi Sharma, Assistant Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01991015     History of Changes
Other Study ID Numbers: NU_STU00077507
K12HD055884 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2013
First Posted: November 25, 2013
Last Update Posted: February 9, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes