Back to resultsEffect of Cancer Nurse Navigators on Patient Outcomes
Primary Purpose
Lung Cancer, Breast Cancer, Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Services from a Nurse Navigator
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring Nurse Navigator, Satisfaction with Care, Quality of Life, Symptom Distress
Eligibility Criteria
Inclusion Criteria:
- Adult (18 years of age or older)
- Treated at Aurora St. Luke's or West Allis Medical Center
- New or recurrent dx of lung, prostate, colorectal or breast cancer -
Exclusion Criteria:
- Previously received CNN services at an Aurora treatment facility
- Unable to read/write in English
- Living in a nursing home/long term care facility
- Not capable of completing study questionnaires -
Sites / Locations
- Aurora St. Luke's Hospital
- Aurora West Allis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Nurse Navigator Services
Services from a Nurse Navigator
Arm Description
Outcomes
Primary Outcome Measures
Satisfaction with Care
Secondary Outcome Measures
ED/Urgent care visits
Quality of Life
The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.
Distressed mood
The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.
Symptom Distress
The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.
The Inventory of Recent Life Experiences for Cancer Patients
This instrument measures 30 cancer-related irritants (hassles) commonly experienced by persons with cancer.
Full Information
NCT ID
NCT01902823
First Posted
November 29, 2011
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Aurora Health Care
1. Study Identification
Unique Protocol Identification Number
NCT01902823
Brief Title
Effect of Cancer Nurse Navigators on Patient Outcomes
Official Title
Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Clinicians were not offering the study to eligible potential subjects.
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Aurora Health Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is widespread anecdotal evidence that Cancer Nurse Navigators (CNNs) are highly valued by cancer patients, but no studies have evaluated the effects of CNNs on important patient-reported outcomes or indicators of quality of care. This study has two aims:
To assess the feasibility of studying the impact of Aurora CNN Program.
To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer
Keywords
Nurse Navigator, Satisfaction with Care, Quality of Life, Symptom Distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Nurse Navigator Services
Arm Type
No Intervention
Arm Title
Services from a Nurse Navigator
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Services from a Nurse Navigator
Intervention Description
Services from a Nurse Navigator
Primary Outcome Measure Information:
Title
Satisfaction with Care
Time Frame
Change from baseline, to 3 months to 6 months
Secondary Outcome Measure Information:
Title
ED/Urgent care visits
Time Frame
Baseline, 3 months, 6 months
Title
Quality of Life
Description
The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.
Time Frame
Baseline, 3 months, 6 months
Title
Distressed mood
Description
The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.
Time Frame
Baseline, 3 months, 6 months
Title
Symptom Distress
Description
The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.
Time Frame
Baseline, 3 months, 6 months
Title
The Inventory of Recent Life Experiences for Cancer Patients
Description
This instrument measures 30 cancer-related irritants (hassles) commonly experienced by persons with cancer.
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (18 years of age or older)
Treated at Aurora St. Luke's or West Allis Medical Center
New or recurrent dx of lung, prostate, colorectal or breast cancer -
Exclusion Criteria:
Previously received CNN services at an Aurora treatment facility
Unable to read/write in English
Living in a nursing home/long term care facility
Not capable of completing study questionnaires -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Kwekkeboom, PhD, RN
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra E Ward, PhD, RN
Organizational Affiliation
Uniuversity of Wisconsin Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora St. Luke's Hospital
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Aurora West Allis
City
West Allis
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
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Effect of Cancer Nurse Navigators on Patient Outcomes
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