NCT01902823

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

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, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
Last Updated

December 13, 2019

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

November 29, 2011

Last Update Submit

December 12, 2019

Conditions

Keywords

Nurse NavigatorSatisfaction with CareQuality of LifeSymptom Distress

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with Care

    Change from baseline, to 3 months to 6 months

Secondary Outcomes (5)

  • ED/Urgent care visits

    Baseline, 3 months, 6 months

  • Quality of Life

    Baseline, 3 months, 6 months

  • Distressed mood

    Baseline, 3 months, 6 months

  • Symptom Distress

    Baseline, 3 months, 6 months

  • The Inventory of Recent Life Experiences for Cancer Patients

    Baseline, 3 months, 6 months

Study Arms (2)

No Nurse Navigator Services

NO INTERVENTION

Services from a Nurse Navigator

EXPERIMENTAL
Behavioral: Services from a Nurse Navigator

Interventions

Services from a Nurse Navigator

Services from a Nurse Navigator

Eligibility Criteria

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

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aurora St. Luke's Hospital

Milwaukee, Wisconsin, United States

Location

Aurora West Allis

West Allis, Wisconsin, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsColorectal NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kristine Kwekkeboom, PhD, RN

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
  • Sandra E Ward, PhD, RN

    Uniuversity of Wisconsin Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

July 18, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 13, 2019

Record last verified: 2015-11

Locations