Effect of Cancer Nurse Navigators on Patient Outcomes

December 12, 2019 updated by: University of Wisconsin, Madison

Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 3

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

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Aurora St. Luke's Hospital
      • West Allis, Wisconsin, United States
        • Aurora West Allis

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

Description

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 -

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with Care
Time Frame: Change from baseline, to 3 months to 6 months
Change from baseline, to 3 months to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED/Urgent care visits
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Quality of Life
Time Frame: Baseline, 3 months, 6 months
The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.
Baseline, 3 months, 6 months
Distressed mood
Time Frame: Baseline, 3 months, 6 months
The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.
Baseline, 3 months, 6 months
Symptom Distress
Time Frame: Baseline, 3 months, 6 months
The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.
Baseline, 3 months, 6 months
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.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Aurora Health Care

Investigators

  • Principal Investigator: Kristine Kwekkeboom, PhD, RN, University of Wisconsin, Madison
  • Principal Investigator: Sandra E Ward, PhD, RN, Uniuversity of Wisconsin Madison

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, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-86E
  • A545000 (Other Identifier: UW Madison)
  • NUR/FACULTY AFFAIRS/ADMIN (Other Identifier: UW Madison)
  • OS11336 (Other Identifier: UW Carbone Cancer Center)

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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