NCT01991015

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

November 18, 2013

Last Update Submit

February 6, 2015

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of end-of-life communication

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rashmi K Sharma, MD, MHS

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

US(1)