Effect of Cancer Nurse Navigators on Patient Outcomes | NCT01902823

Studies
Effect of Cancer Nurse Navigators on Patient Outcomes

NCT01902823

Sponsor

University of Wisconsin, Madison

Status

Terminated

Last Update Posted

Dec 13, 2019Actual

Enrollment

16Actual

Phase

Phase 2Phase 3

Conditions

Lung Cancer
Breast Cancer
Colorectal Cancer
Prostate Cancer

Interventions

Services from a Nurse Navigator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
OS11336	Other Identifier	UW Carbone Cancer Center
A545000	Other Identifier	UW Madison
NUR/FACULTY AFFAIRS/ADMIN	Other Identifier	UW Madison

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Clinicians were not offering the study to eligible potential subjects.

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Nov 29, 2011

First Submission Date that Met QC Criteria

Jul 15, 2013

First Posted Date

Jul 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 13, 2019Actual

Name	Class
Wake Forest University Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Nurse Navigator Services	No Intervention
Services from a Nurse Navigator	Experimental		Behavioral: Services from a Nurse Navigator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Services from a Nurse Navigator	Behavioral	Services from a Nurse Navigator	Services from a Nurse Navigator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
ED/Urgent care visits		Baseline, 3 months, 6 months
Quality of Life	The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.	Baseline, 3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristine Kwekkeboom, PhD, RN	University of Wisconsin, Madison	Principal Investigator
Sandra E Ward, PhD, RN	Uniuversity of Wisconsin Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aurora St. Luke's Hospital		Milwaukee	Wisconsin		United States
Aurora West Allis

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D001943	Breast Neoplasms
D015179	Colorectal Neoplasms
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided