Goals of Care Discussions for Hospitalized Patients With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rashmi Sharma, Northwestern University
ClinicalTrials.gov Identifier:
NCT01991015
First received: November 18, 2013
Last updated: July 15, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of end-of-life communication [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991015

Contacts
Contact: Rashmi K Sharma, MD, MHS 312-926-0096 rasharma@nmh.org

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Rashmi K Sharma, MD, MHS         
Sub-Investigator: Kenzie Cameron, PhD         
Sub-Investigator: Frank Penedo, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Rashmi K Sharma, MD, MHS Northwestern University
  More Information

No publications provided

Responsible Party: Rashmi Sharma, Assistant Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01991015     History of Changes
Other Study ID Numbers: NU_STU00077507, K12HD055884
Study First Received: November 18, 2013
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014