Patient Navigation in the Safety Net:CONNECTeDD

Breast Cancer Clinical Trial

Official title:

Patient Navigation in the Safety Net:CONNECTeDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613275
• Other study ID #: U01CA116892-03
• Secondary ID: U01CA116892
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2008
• Last updated: June 14, 2016
• Start date: July 2005
• Est. completion date: September 2011

Study information

• Verified date: June 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4038
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 years	No
Secondary	Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs		4 years	No