Clinical trial NCT01569672: Ohio Patient Navigator Research Program
Official title: Ohio Patient Navigation Research Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Colon Cancer
Rectal Cancer
Abnormal Breast Cancer Screening Tests
Abnormal Cervical Cancer Screening Tests
Abnormal Colon Cancer Screening Tests
Keywords: Navigator
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2012-04-03
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Ohio Patient Navigator Research Program (OPNRP) proposes to alleviate disparities in relation to the timely diagnosis and treatment of breast, cervical and colorectal cancer in Columbus, OH.

Detailed description: The goal of the Ohio Patient Navigator Research Program (OPNRP) is to facilitate timely access to quality, standard cancer care for persons diagnosed with breast, cervical, and colorectal cancer in a culturally sensitive manner. This program will be carried out within clinics of The Ohio State University Primary Care Network (OSU PCN) and the Columbus Neighborhood Health Centers (CNHC) in Columbus, Ohio with a preponderance of patients from underserved (i.e., racial/ethnic minorities, people of lower socioeconomic status, and the elderly) populations. This goal will be accomplished by completing the following objectives:

Objectives

* Develop the OPNRP through the work of a consortium of institutions including The Ohio State University Comprehensive Cancer Center (OSUCCC) and James Cancer Hospital (JCH), the Ohio Division of the American Cancer Society (ACS), and the Ohio Commission on Minority Health (OCMH);
* Conduct a formative research phase to assess referral patterns and barriers to prompt diagnosis and treatment services, as well as strategies to overcome barriers among patients of these clinic networks;
* Implement and evaluate the patient navigator program in 12 primary care clinics using a group randomized, controlled design to assess the efficacy of the intervention to reduce the time to delivery of standard cancer diagnosis and services and non-cancer resolution or cancer diagnosis and treatment after the diagnosis of an abnormal finding from a cancer detection procedure for breast, cervical or colorectal cancer, as well as improve patient satisfaction with care and quality of life;
* Conduct a process evaluation to assess the barriers to implementation of the intervention program, the features of the intervention (e.g., appointments kept/missed, materials provided to patients, etc.), patient satisfaction with the navigator, and clinic perceptions of the navigator program; and
* Conduct a cost-effectiveness evaluation of the navigator program. Results from this study will be disseminated throughout Ohio by community partners and used to provide information on concrete ways to utilize patient navigators to reduce the burden of cancer in underserved populations, a goal of the National Cancer Institute (NCI) and Department of Health and Human Services (DHS) Healthy People 2010. The OPNRP is one of nine grantees in NCI/ACS's Patient Navigator Research Program (PNRP).

Eligibility criteria: Inclusion Criteria:

* Over age 18 years
* Be a regular patient of the primary care practice
* Be able to give informed consent
* Have had either an abnormal screening test, an abnormal diagnostic test, or an abnormal clinical finding leading to diagnostic testing for cervical, breast, or colorectal cancer, or a diagnosis of cervical, breast, or colorectal cancer
* Speak and understand English, or Spanish. For those participants who do not speak and understand English they will only be enrolled/consented into the program if translation services are available.

Exclusion Criteria:

* Cognitively impaired
* Prior history of cancer (except for nonmelanoma of the skin)
* Living in a nursing home
* Prior navigation

Primary outcomes:
measure: Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment
timeFrame: Up to one year
Secondary outcomes:
measure: Number of barriers and effect of barriers on receiving needed tests and treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Electra D Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.