Patient Navigator Project
Primary Purpose
Breast Cancer, Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Clinic Staff
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Patient navigation, Breast cancer, Colon cancer, Questionnaire
Eligibility Criteria
Inclusion Criteria:
- Receive health care at one of the enrolled clinics
- Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement).
Exclusion Criteria:
- Persons with previous history of breast or colon cancer will be excluded from the study
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1: Patient Navigator
2: Without Navigator
Arm Description
Patients will meet with a Patient Navigator regarding their treatment and any related concerns.
Patient will work with existing clinic staff, which does not include a Patient Navigator.
Outcomes
Primary Outcome Measures
Questionnaire Results Regarding Time to Diagnosis
Time from finding of abnormality to definitive diagnosis
Secondary Outcome Measures
Patient Satisfaction Questionaire Results
Questionnaire Results Regarding Patient Navigators
To determine if patient navigators are cost effective
Full Information
NCT ID
NCT00375024
First Posted
September 11, 2006
Last Updated
November 2, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00375024
Brief Title
Patient Navigator Project
Official Title
Patient Navigator Project
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patient Navigation is a Supportive Care Intervention that addresses barriers to quality standard care by providing individualized assistance to patients and families. The NCI is conducting several research programs to test the effectiveness of this approach. The expected outcomes of patient navigation through the cancer care system include:
Timely, definitive diagnosis following an abnormal test
Timely treatment following positive diagnosis
Patient satisfaction with the diagnostic and care system experience
Detailed Description
The goal of our local project is to provide Tampa Bay with a culturally appropriate Patient Navigator Program that will decrease delay in diagnosis and delivery of cancer care in an acceptable and cost-effective manner leading to lower cancer mortality among our underserved populations. We will partner with community health centers in the Tampa Bay area to provide an avenue for patients who have received an abnormal screening for breast and colorectal cancer to easier pilot the course of the healthcare system. The populations served by this program will include African-Americans, Hispanics and rural Whites who are medically underserved due to lack of insurance, documentation issues and a variety of other barriers to health care.
The primary outcome to be tested with this program is the time it takes for patients with an abnormality to receive a definitive diagnosis. Secondary outcomes such as patient satisfaction and cost-effectiveness will also be measured. This program occurs in three phases. In Phase I, the aim is to work closely with our key community partners to conduct formative research for the development of an acceptable, appealing, and appropriate Patient Navigator Program. The aim for Phase II is to conduct a group randomized controlled trial by having participating clinics randomly assigned to an intervention or control clinic. The outcomes from this phase in the project will be assessed through chart reviews, patient satisfaction surveys and other survey methods. In Phase III a comprehensive evaluation on the program will be produced and disseminated nationally.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer
Keywords
Patient navigation, Breast cancer, Colon cancer, Questionnaire
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1267 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Patient Navigator
Arm Type
Other
Arm Description
Patients will meet with a Patient Navigator regarding their treatment and any related concerns.
Arm Title
2: Without Navigator
Arm Type
Other
Arm Description
Patient will work with existing clinic staff, which does not include a Patient Navigator.
Intervention Type
Procedure
Intervention Name(s)
Patient Navigation
Intervention Description
Inclusion of Patient Navigator in treatment plan.
Intervention Type
Procedure
Intervention Name(s)
Clinic Staff
Intervention Description
Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.
Primary Outcome Measure Information:
Title
Questionnaire Results Regarding Time to Diagnosis
Description
Time from finding of abnormality to definitive diagnosis
Time Frame
Individual per patient
Secondary Outcome Measure Information:
Title
Patient Satisfaction Questionaire Results
Time Frame
At end of patient participation
Title
Questionnaire Results Regarding Patient Navigators
Description
To determine if patient navigators are cost effective
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receive health care at one of the enrolled clinics
Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement).
Exclusion Criteria:
Persons with previous history of breast or colon cancer will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Roetzheim, MD, MSPH
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27432417
Citation
Battaglia TA, Darnell JS, Ko N, Snyder F, Paskett ED, Wells KJ, Whitley EM, Griggs JJ, Karnad A, Young H, Warren-Mears V, Simon MA, Calhoun E. The impact of patient navigation on the delivery of diagnostic breast cancer care in the National Patient Navigation Research Program: a prospective meta-analysis. Breast Cancer Res Treat. 2016 Aug;158(3):523-34. doi: 10.1007/s10549-016-3887-8. Epub 2016 Jul 18.
Results Reference
derived
PubMed Identifier
26438146
Citation
Wells KJ, Winters PC, Jean-Pierre P, Warren-Mears V, Post D, Van Duyn MA, Fiscella K, Darnell J, Freund KM; Patient Navigation Research Program Investigators. Effect of patient navigation on satisfaction with cancer-related care. Support Care Cancer. 2016 Apr;24(4):1729-53. doi: 10.1007/s00520-015-2946-8. Epub 2015 Oct 5.
Results Reference
derived
PubMed Identifier
26348120
Citation
Rodday AM, Parsons SK, Snyder F, Simon MA, Llanos AA, Warren-Mears V, Dudley D, Lee JH, Patierno SR, Markossian TW, Sanders M, Whitley EM, Freund KM. Impact of patient navigation in eliminating economic disparities in cancer care. Cancer. 2015 Nov 15;121(22):4025-34. doi: 10.1002/cncr.29612. Epub 2015 Sep 8.
Results Reference
derived
PubMed Identifier
25071111
Citation
Ko NY, Darnell JS, Calhoun E, Freund KM, Wells KJ, Shapiro CL, Dudley DJ, Patierno SR, Fiscella K, Raich P, Battaglia TA. Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program. J Clin Oncol. 2014 Sep 1;32(25):2758-64. doi: 10.1200/JCO.2013.53.6037. Epub 2014 Jul 28.
Results Reference
derived
PubMed Identifier
24066145
Citation
Lee JH, Fulp W, Wells KJ, Meade CD, Calcano E, Roetzheim R. Patient navigation and time to diagnostic resolution: results for a cluster randomized trial evaluating the efficacy of patient navigation among patients with breast cancer screening abnormalities, Tampa, FL. PLoS One. 2013 Sep 16;8(9):e74542. doi: 10.1371/journal.pone.0074542. eCollection 2013.
Results Reference
derived
Links:
URL
http://www.moffitt.org
Description
H Lee Moffiitt Cancer Center & Research Institute website
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Patient Navigator Project
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