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Patient Navigation in the Safety Net:CONNECTeDD

Phase 4
18 Years
Open (Enrolling)
Breast Cancer, Cervical Cancer

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Trial Information

Patient Navigation in the Safety Net:CONNECTeDD

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Karen M Freund, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Cervical Cancer
  • PNRP
  • Navigation
  • Navigator
  • Activation
  • Disparities
  • Primary Care
  • Racial and Ethnic Minorities
  • Breast Neoplasms
  • Uterine Cervical Neoplasms



Boston Medical Center Boston, Massachusetts  02118