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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
January 10, 2008
Last Updated
July 25, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Ralph Lauren Center for Cancer Care and Prevention, North General Hospital, New York
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1. Study Identification

Unique Protocol Identification Number
NCT00597454
Brief Title
An Access Delivery Model That Eliminates Barriers to Breast Cancer Care Delivery
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Ralph Lauren Center for Cancer Care and Prevention, North General Hospital, New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Harper, MD, MPH
Organizational Affiliation
Memorial Sloan Kettering Cancer Center/Ralph Lauren Center for Cancer Care and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

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

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