An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00597454|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : July 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Patient Navigation||Not Applicable|
This purpose of this protocol is to systematically evaluate the role of Patient Navigators, non-medical personnel who assist in the coordination of care, for women attending a breast cancer screening clinic in Harlem who are found to have a suspicious result. The concept of patient navigation, developed by Dr. Harold Freeman, has been identified as a promising strategy to reduce disparities in health care for minorities and the underserved.
This protocol will evaluate the role of the Patient Navigator in coordinating care for women who are referred to the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) from the Breast Examination Center of Harlem (BECH). To achieve this, we propose four interrelated tasks. First, we will characterize in detail the specific nature of the activities of the Navigators as they remedy barriers to the receipt of breast cancer care. Secondly, we will determine whether the presence of the Navigator minimizes the percentage of patients with significant delays in receipt of necessary care. Third, we will measure patient satisfaction with care and their perceptions of the value of the Navigator. Finally, we will provide a baseline needs assessment of those (eligible) patients requiring pain and palliation services.
- To characterize the role of Patient Navigators by defining the specific tasks and activities they perform in order to eliminate and/or reduce barriers to receipt of cancer care.
- To evaluate how the presence of a Patient Navigator influences the time intervals from receipt of a suspicious screening mammogram or palpable breast mass to appropriate diagnosis and or treatment.
- To measure patient's satisfaction with the coordination of care in the presence of a Patient Navigator.
- To descriptively assess the pain and palliation needs of the population under study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery With Emphasis on the Coordination of Care Within and Between an Outpatient Screening Facility and a Diagnostic and Treatment Center|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Other: Patient Navigation
we will conduct a detailed analysis of how the patient navigators' time is actually utilized by having them record a detailed log categorizing their activities as it relates to the elimination of recognized barriers to care. Second, we will measure the time interval from receipt of a suspicious mammogram to appropriate diagnostic evaluation and or treatment.
We will measure the number of women who experience diagnostic and or treatment delay and whether the presence of a Patient Navigator enables delivery of coordinated care that avoids delays. Third, we will measure patients' satisfaction with aspects of their care, focusing particularly on care coordination using validated instruments designed for this purpose.
- Eval how Navigators spend time & specific tasks undertake to coordinate care.Specificatn of time intervals from receipt of suspicious screening mammogram to receipt of approp diagnostic eval.Pt satisfaction evaluatn take place w/in 1 month of i [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597454
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Brian Harper, MD, MPH||Memorial Sloan Kettering Cancer Center/Ralph Lauren Center for Cancer Care and Prevention|