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Patient Navigation in the Safety Net:CONNECTeDD

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. Identifier: NCT00613275
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
Battaglia, Tracy, Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cervical Cancer Other: patient Navigation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4038 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient Navigation in the Safety Net:CONNECTeDD
Study Start Date : July 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Intervention Details:
  • Other: patient Navigation
    Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers

Primary Outcome Measures :
  1. 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 Measures :
  1. Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00613275

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Karen M Freund, MD, MPH Boston Medical Center
Principal Investigator: Tracy Battaglia, MD, MPH Boston Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Battaglia, Tracy, Assistant Professor, Boston Medical Center Identifier: NCT00613275     History of Changes
Other Study ID Numbers: U01CA116892-03 ( U.S. NIH Grant/Contract )
U01CA116892 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

Keywords provided by Battaglia, Tracy, Boston Medical Center:
Primary Care
Racial and Ethnic Minorities

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female