NCT00496678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Apr 2007

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 9, 2013

Status Verified

December 1, 2007

Enrollment Period

3.2 years

First QC Date

July 3, 2007

Last Update Submit

August 6, 2013

Conditions

Breast CancerColorectal Cancer

Keywords

PNRPnavigationnavigatoractivationdisparitiesrandomized control trialprimary careracial and ethnic minorities

Outcome Measures

Primary Outcomes (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.

    5 years

Secondary Outcomes (1)

  • Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs.

    5 years

Study Arms (2)

Navigation

EXPERIMENTAL

Navigation through the cancer care system is the intervention

Behavioral: Navigation

Standard of Care

ACTIVE COMPARATOR

Cancer patient receives standard of care.

Behavioral: Standard of Care

Interventions

NavigationBEHAVIORAL

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

Navigation
Standard of CareBEHAVIORAL

Cancer patients receive standard of care for their cancer treatment

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receive care at a participating practice
  • 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

You may not qualify if:

  • 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
  • History of prior invasive cancer, lymphoma, or leukemia except non-melanoma (basal or squamous of the skin) cancer or CIN (Cervical intraepithelial neoplasia).
  • 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.
  • Women who are pregnant at time of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (5)

  • Battaglia TA, Darnell JS, Ko N, Snyder F, Paskett ED, Wells KJ, Whitley EM, Griggs JJ, Karnad A, Young H, Warren-Mears V, Simon MA, Calhoun E. The impact of patient navigation on the delivery of diagnostic breast cancer care in the National Patient Navigation Research Program: a prospective meta-analysis. Breast Cancer Res Treat. 2016 Aug;158(3):523-34. doi: 10.1007/s10549-016-3887-8. Epub 2016 Jul 18.

    PMID: 27432417DERIVED

  • Wells KJ, Winters PC, Jean-Pierre P, Warren-Mears V, Post D, Van Duyn MA, Fiscella K, Darnell J, Freund KM; Patient Navigation Research Program Investigators. Effect of patient navigation on satisfaction with cancer-related care. Support Care Cancer. 2016 Apr;24(4):1729-53. doi: 10.1007/s00520-015-2946-8. Epub 2015 Oct 5.

    PMID: 26438146DERIVED

  • Rodday AM, Parsons SK, Snyder F, Simon MA, Llanos AA, Warren-Mears V, Dudley D, Lee JH, Patierno SR, Markossian TW, Sanders M, Whitley EM, Freund KM. Impact of patient navigation in eliminating economic disparities in cancer care. Cancer. 2015 Nov 15;121(22):4025-34. doi: 10.1002/cncr.29612. Epub 2015 Sep 8.

    PMID: 26348120DERIVED

  • Ko NY, Darnell JS, Calhoun E, Freund KM, Wells KJ, Shapiro CL, Dudley DJ, Patierno SR, Fiscella K, Raich P, Battaglia TA. Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program. J Clin Oncol. 2014 Sep 1;32(25):2758-64. doi: 10.1200/JCO.2013.53.6037. Epub 2014 Jul 28.

    PMID: 25071111DERIVED

  • Hendren S, Griggs JJ, Epstein RM, Humiston S, Rousseau S, Jean-Pierre P, Carroll J, Yosha AM, Loader S, Fiscella K. Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities. BMC Cancer. 2010 Oct 13;10:551. doi: 10.1186/1471-2407-10-551.

    PMID: 20939928DERIVED

MeSH Terms

Conditions

Breast NeoplasmsColorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kevin Fiscella, M.D., MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

August 9, 2013

Record last verified: 2007-12

Locations

US(1)