Lung CancerPhase 2/3NCT01902823
Effect of Cancer Nurse Navigators on Patient Outcomes
A Phase 2/3 study testing Services from a Nurse Navigator in people with Lung Cancer and Breast Cancer, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Services from a Nurse Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aurora St. Luke's Hospital
Milwaukee, Wisconsin
Aurora West Allis
West Allis, Wisconsin
About this study
Official title: 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:
- 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.
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- Services from a Nurse Navigator
- Keywords
- Nurse Navigator, Satisfaction with Care, Quality of Life, Symptom Distress
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Services from a Nurse NavigatorBehavioural
Services from a Nurse Navigator
| Study group | Role | What they receive |
|---|---|---|
| No Nurse Navigator Services | No intervention | Not described |
| Services from a Nurse Navigator | Experimental | Not described Receives: Behavioral: Services from a Nurse Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Care
Measured: Change from baseline, to 3 months to 6 months
Secondary outcomes (5)
ED/Urgent care visits
Measured: Baseline, 3 months, 6 months
Quality of Life
The Functional Assessment Cancer Therapy - General (FACT-G) assesses quality of life.
Measured: Baseline, 3 months, 6 months
Distressed mood
The National Comprehensive Cancer Network Distress Thermometer assesses level of distress.
Measured: Baseline, 3 months, 6 months
Symptom Distress
The Memorial Symptom Assessment Scale measures 32 common physical and psychological cancer-related symptoms.
Measured: Baseline, 3 months, 6 months
The Inventory of Recent Life Experiences for Cancer Patients
This instrument measures 30 cancer-related irritants (hassles) commonly experienced by persons with cancer.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Clinicians were not offering the study to eligible potential subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Kristine Kwekkeboom, PhD, RN, Principal investigator, University of Wisconsin, MadisonSandra E Ward, PhD, RN, Principal investigator, Uniuversity of Wisconsin Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902823
- Sponsor's protocol ID
- 11-86E
- Other IDs
- OS11336, A545000, NUR/FACULTY AFFAIRS/ADMIN
- Status last verified
- Nov 2015
- First submitted
- 29 Nov 2011
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of the Effect of Cancer Nurse Navigators on Patient Outcomes
- ClinicalTrials.gov ID
- NCT01902823
- Acronym / sponsor ID
- 11-86E
- Conditions
- Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer
- Keywords
- Nurse Navigator, Satisfaction with Care, Quality of Life, Symptom Distress
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinicians were not offering the study to eligible potential subjects.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Nurse Navigator Services | No intervention | – |
| Services from a Nurse Navigator | Experimental | Behavioral: Services from a Nurse Navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Services from a Nurse NavigatorServices from a Nurse Navigator | Behavioural | Services from a Nurse Navigator |
Primary outcome
Satisfaction with Care
Time frame: Change from baseline, to 3 months to 6 months
5 secondary outcomes
ED/Urgent care visits
Time frame: Baseline, 3 months, 6 months
Quality of Life
Time frame: Baseline, 3 months, 6 months
Distressed mood
Time frame: Baseline, 3 months, 6 months
Symptom Distress
Time frame: Baseline, 3 months, 6 months
The Inventory of Recent Life Experiences for Cancer Patients
Time frame: Baseline, 3 months, 6 months
Results and safety
The study was stopped early (reason given: Clinicians were not offering the study to eligible potential subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Kwekkeboom, PhD, RN principal investigator
University of Wisconsin, Madison
Sandra E Ward, PhD, RN principal investigator
Uniuversity of Wisconsin Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Services from a Nurse Navigator in people with Lung Cancer and Breast Cancer, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Clinicians were not offering the study to eligible potential subjects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Care (time frame: Change from baseline, to 3 months to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.