Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Trial of Patient Navigation-Activation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00496678
First received: July 3, 2007
Last updated: August 6, 2013
Last verified: December 2007
  Purpose

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 Intervention Phase
Breast Cancer
Colorectal Cancer
Behavioral: Navigation
Behavioral: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: RCT of Primary Care-based Patient Navigation-Activation

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ 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: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00496678

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Kevin Fiscella, M.D., MPH University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Fiscella M.D. MPH, University of Rochester
ClinicalTrials.gov Identifier: NCT00496678     History of Changes
Other Study ID Numbers: RO1U01CA116924
Study First Received: July 3, 2007
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
PNRP
navigation
navigator
activation
disparities
randomized control trial
primary care
racial and ethnic minorities

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

ClinicalTrials.gov processed this record on November 25, 2014