Trial of Patient Navigation-Activation

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: NCT00496678
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : August 9, 2013
National Cancer Institute (NCI)
Information provided by:
University of Rochester

Brief Summary:

The University of Rochester, Department of Family Medicine, funded by the National Cancer Institute will train community health workers 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 colorectal cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, patient satisfaction with care and quality of life.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Behavioral: Navigation Behavioral: Standard of Care 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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: RCT of Primary Care-based Patient Navigation-Activation
Study Start Date : April 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Navigation
Navigation through the cancer care system is the intervention
Behavioral: Navigation
Cancer patients are randomly assigned to receive standard of care or the help of a trained person to navigated them through the cancer care system
Active Comparator: Standard of Care
Cancer patient receives standard of care.
Behavioral: Standard of Care
Cancer patients receive standard of care for their cancer treatment

Primary Outcome Measures :
  1. 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. [ Time Frame: 5 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: 5 years ]

Information from the National Library of Medicine

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

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.

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): NCT00496678

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Kevin Fiscella, M.D., MPH University of Rochester

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Kevin Fiscella M.D. MPH, University of Rochester Identifier: NCT00496678     History of Changes
Other Study ID Numbers: RO1U01CA116924
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: December 2007

Keywords provided by University of Rochester:
randomized control trial
primary care
racial and ethnic minorities

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases