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Patient Navigation in the Safety Net:CONNECTeDD

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
patient Navigation
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring PNRP, Navigation, Navigator, Activation, Disparities, Primary Care, Racial and Ethnic Minorities

Eligibility Criteria

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

Inclusion Criteria:

  • Receive care at one of the 6 participating community Health centers
  • Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day
  • Have been newly diagnosed with breast or colorectal cancer
  • Have received notification by the provider of an abnormal breast or colorectal screening result

Exclusion Criteria:

  • Cognitively impaired
  • Institutionalized (nursing home, incarcerated)
  • Children <18
  • Actively involved in cancer treatment at time of presentation
  • Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer

Sites / Locations

  • Boston Medical Center

Outcomes

Primary Outcome Measures

Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care

Secondary Outcome Measures

Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs

Full Information

First Posted
January 30, 2008
Last Updated
June 14, 2016
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00613275
Brief Title
Patient Navigation in the Safety Net:CONNECTeDD
Official Title
Patient Navigation in the Safety Net:CONNECTeDD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers to guide patients through the cancer care system. The project will help to teach patients how to communicate more effectively with their health care team in order to understand the treatment options available to them. Although not widely available, it is believed patient navigation programs are beneficial. This research study will evaluate how well this tool works, especially among those who experience disparities in health care. The goal is to determine if having a trained navigator shortens the time between an abnormal test result and a definitive diagnosis and between a definitive diagnosis and completion of treatment for breast and Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's care and quality of life.
Detailed Description
Racial and ethnic minority groups and low-income persons experience significantly higher cancer mortality rates than other Americans. These disparities are due to at least two factors: (1) delays in follow-up of abnormal cancer screening results and (2) suboptimal management of diagnosed cancer. Patient navigation represents a promising means for addressing disparities by improving cancer related management for minority and other underserved populations. However, patient navigation for cancer has yet to be evaluated through a well-designed randomized controlled trial. Furthermore, patient navigation is likely to prove most effective and sustainable when it is integrated into primary care and helps patients be more active in their care. This combination of patient empowerment and engagement is referred to as "activation." The aim of this project is to evaluate the effectiveness and costs of such a program in a rigorous manner so that the results can be generalized and the program can be widely disseminated and implemented. We will develop, implement, and evaluate a primary care-based, patient navigation-activation program using specially-trained patient Navigators who work within one of the six affiliated Community Health Centers. We propose to investigate the effect of this intervention on timing and quality of cancer-related care. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation, and total costs. Project findings will inform national policy regarding patient navigation for cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
PNRP, Navigation, Navigator, Activation, Disparities, Primary Care, Racial and Ethnic Minorities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4038 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
patient Navigation
Intervention Description
Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers
Primary Outcome Measure Information:
Title
Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs
Time Frame
4 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receive care at one of the 6 participating community Health centers Have received a positive breast or colorectal cancer screening test requiring follow-up on a different day Have been newly diagnosed with breast or colorectal cancer Have received notification by the provider of an abnormal breast or colorectal screening result Exclusion Criteria: Cognitively impaired Institutionalized (nursing home, incarcerated) Children <18 Actively involved in cancer treatment at time of presentation Currently or previously navigated with (a) navigation documented in the medical record or (b) patient can articulate that they are in a navigation program or case management program for cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Freund, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracy Battaglia, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
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

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Patient Navigation in the Safety Net:CONNECTeDD

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