- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991015
Goals of Care Discussions for Hospitalized Patients With Advanced Cancer
February 6, 2015 updated by: Rashmi Sharma, Northwestern University
Gender Differences in Inpatient Goals of Care Discussions in Patients With Advanced Cancer
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- English speaking, have metastatic cancer that has progressed despite treatment
Exclusion Criteria:
- Cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rashmi K Sharma, MD, MHS, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 21, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
February 9, 2015
Last Update Submitted That Met QC Criteria
February 6, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU_STU00077507
- K12HD055884 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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