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RCT of Primary Care-based Patient Navigation-Activation

Phase 4
18 Years
Not Enrolling
Breast Cancer, Colorectal Cancer

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Trial Information

RCT of Primary Care-based Patient Navigation-Activation

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
enablement 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 community health workers (CHWs). 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:

1. Receive care at a participating practice

2. Have received a positive breast or colorectal cancer screening test requiring
follow-up on a different day

3. Have been newly diagnosed with breast or colorectal cancer

4. Have received notification by the provider of an abnormal breast or colorectal
screening result

Exclusion Criteria:

1. Cognitively impaired

2. Institutionalized (nursing home, incarcerated)

3. Children <18

4. Actively involved in cancer treatment at time of presentation

5. 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

6. History of prior invasive cancer, lymphoma, or leukemia except non-melanoma (basal or
squamous of the skin) cancer or CIN (Cervical intraepithelial neoplasia).

7. Prior cancer that has been treated—The rationale for excluding patients with any
prior cancers that have been treated is that patient familiarity with the treatment
process in general would make care easier even without a navigator.

8. Women who are pregnant at time of enrollment.

Type of Study:


Study Design:

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

Outcome Measure:

To develop, implement, and evaluate a primary care-based, patient navigation program using specially-trained community health workers. We will investigate the effect of this intervention on timing and quality of cancer-related care.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Kevin Fiscella, M.D., MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

August 2010

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • PNRP
  • navigation
  • navigator
  • activation
  • disparities
  • randomized control trial
  • primary care
  • racial and ethnic minorities
  • Breast Neoplasms
  • Colorectal Neoplasms



University of Rochester Rochester, New York  14642