Patient Navigator Project
1 other identifier
interventional
1,267
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2007
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2006
CompletedFirst Posted
Study publicly available on registry
September 12, 2006
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 6, 2012
November 1, 2012
5.3 years
September 11, 2006
November 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Questionnaire Results Regarding Time to Diagnosis
Time from finding of abnormality to definitive diagnosis
Individual per patient
Secondary Outcomes (2)
Patient Satisfaction Questionaire Results
At end of patient participation
Questionnaire Results Regarding Patient Navigators
End of study
Study Arms (2)
1: Patient Navigator
OTHERPatients will meet with a Patient Navigator regarding their treatment and any related concerns.
2: Without Navigator
OTHERPatient will work with existing clinic staff, which does not include a Patient Navigator.
Interventions
Specific Patient Navigator will not be included in treatment plan. Existing clinical staff will work with the patients.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Persons with previous history of breast or colon cancer will be excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Related Publications (5)
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.
PMID: 27432417DERIVEDWells 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.
PMID: 26438146DERIVEDRodday 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.
PMID: 26348120DERIVEDKo 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.
PMID: 25071111DERIVEDLee 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.
PMID: 24066145DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Roetzheim, MD, MSPH
University of South Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2006
First Posted
September 12, 2006
Study Start
May 1, 2007
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
November 6, 2012
Record last verified: 2012-11