Patient Navigation in the Safety Net:CONNECTeDD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Boston Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00613275
First received: January 30, 2008
Last updated: October 4, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Breast Cancer
Cervical Cancer
Other: patient Navigation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Patient Navigation in the Safety Net:CONNECTeDD

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 7648
Study Start Date: July 2005
Estimated Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00613275

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

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen M. Freund, MD, MPH, Boston University Medical Center
ClinicalTrials.gov Identifier: NCT00613275     History of Changes
Other Study ID Numbers: U01-CA-116892-03, U01-CA-116892-03
Study First Received: January 30, 2008
Last Updated: October 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
PNRP
Navigation
Navigator
Activation
Disparities
Primary Care
Racial and Ethnic Minorities

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

ClinicalTrials.gov processed this record on October 23, 2014