An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery

This study has been completed.
Sponsor:
Collaborators:
Ralph Lauren Center for Cancer Care and Prevention
North General Hospital, New York
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00597454
First received: January 10, 2008
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

The purpose of the research is to examine the usefulness of using patient navigators in improving coordination of care between the Breast Examination Center in Harlem (BECH) and the Ralph Lauren Center for Cancer Care and Prevention (RLCCCP) for patients with a suspicious breast finding. This study will collect information to improve the role of the Patient Navigator, nonmedical staff that helps coordinate patient care. The study will also collect information to be used to help remove barriers that happen when several different institutions provide care.


Condition Intervention
Breast Cancer
Other: Patient Navigation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2004
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.


Detailed Description:

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.

Specific Aims:

  1. 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.
  2. 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.
  3. To measure patient's satisfaction with the coordination of care in the presence of a Patient Navigator.
  4. To descriptively assess the pain and palliation needs of the population under study.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with a suspicious screening finding
  • Referred from Breast Examination Center of Harlem (BECH)

Exclusion Criteria:

  • Women that were not initially seen at Breast Examination Center of Harlem (BECH)
  • Women with normal breast screening findings
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597454

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Ralph Lauren Center for Cancer Care and Prevention
North General Hospital, New York
Investigators
Principal Investigator: Brian Harper, MD, MPH Memorial Sloan Kettering Cancer Center/Ralph Lauren Center for Cancer Care and Prevention
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597454     History of Changes
Other Study ID Numbers: 04-067
Study First Received: January 10, 2008
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014