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Effect of Cancer Nurse Navigators on Patient Outcomes

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.
ClinicalTrials.gov Identifier: NCT01902823
Recruitment Status : Terminated (Clinicians were not offering the study to eligible potential subjects.)
First Posted : July 18, 2013
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
Aurora Health Care
Information provided by (Responsible Party):
University of Wisconsin, Madison

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:

  1. To assess the feasibility of studying the impact of Aurora CNN Program.
  2. To pilot test the effects of CNN services on patient-reported outcomes and indicators of quality of care.

Condition or disease Intervention/treatment Phase
Lung Cancer Breast Cancer Colorectal Cancer Prostate Cancer Behavioral: Services from a Nurse Navigator Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes
Study Start Date : November 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Nurse Navigator Services
Experimental: Services from a Nurse Navigator Behavioral: Services from a Nurse Navigator
Services from a Nurse Navigator




Primary Outcome Measures :
  1. Satisfaction with Care [ Time Frame: Change from baseline, to 3 months to 6 months ]

Secondary Outcome Measures :
  1. ED/Urgent care visits [ Time Frame: Baseline, 3 months, 6 months ]
  2. Quality of Life [ Time Frame: Baseline, 3 months, 6 months ]
    The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.

  3. Distressed mood [ Time Frame: Baseline, 3 months, 6 months ]
    The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.

  4. Symptom Distress [ Time Frame: Baseline, 3 months, 6 months ]
    The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.

  5. The Inventory of Recent Life Experiences for Cancer Patients [ Time Frame: Baseline, 3 months, 6 months ]
    This instrument measures 30 cancer-related irritants (hassles) commonly experienced by persons with cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (18 years of age or older)
  2. Treated at Aurora St. Luke's or West Allis Medical Center
  3. New or recurrent dx of lung, prostate, colorectal or breast cancer -

Exclusion Criteria:

  1. Previously received CNN services at an Aurora treatment facility
  2. Unable to read/write in English
  3. Living in a nursing home/long term care facility
  4. Not capable of completing study questionnaires -

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): NCT01902823


Locations
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United States, Wisconsin
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, United States
Aurora West Allis
West Allis, Wisconsin, United States
Sponsors and Collaborators
University of Wisconsin, Madison
Aurora Health Care
Investigators
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Principal Investigator: Kristine Kwekkeboom, PhD, RN University of Wisconsin, Madison
Principal Investigator: Sandra E Ward, PhD, RN Uniuversity of Wisconsin Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01902823     History of Changes
Other Study ID Numbers: 11-86E
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by University of Wisconsin, Madison:
Nurse Navigator
Satisfaction with Care
Quality of Life
Symptom Distress

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases