Ohio Patient Navigator Research Program (OPNRP)
Primary Purpose
Breast Cancer, Cervical Cancer, Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigator matched with subject
Subjects are mailed informational/educational materials
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Navigator
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
Sites / Locations
- The Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Clinic
Control Clinics
Arm Description
Patient Navigator matched with subjects. Patient Navigators will be matched with subjects at the intervention clinics and will assist patients with questions, issues or concerns with their cancer treatment/diagnosis or abnormal test results and followup test or treatments
Subjects are mailed informational/educational materials.
Outcomes
Primary Outcome Measures
Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment
How much time exist between an abnormal test diagnosis for breast, cervical or colon or rectum cancer to when the needed follow up tests or treatment is done.
Secondary Outcome Measures
Number of barriers and effect of barriers on receiving needed tests and treatment
List of and number of barriers and qualitatively how they influence a person's reasons for not getting a needed screening test or treatment
Full Information
NCT ID
NCT01569672
First Posted
March 19, 2012
Last Updated
February 22, 2021
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01569672
Brief Title
Ohio Patient Navigator Research Program
Acronym
OPNRP
Official Title
Ohio Patient Navigation Research Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
941 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Clinic
Arm Type
Active Comparator
Arm Description
Patient Navigator matched with subjects. Patient Navigators will be matched with subjects at the intervention clinics and will assist patients with questions, issues or concerns with their cancer treatment/diagnosis or abnormal test results and followup test or treatments
Arm Title
Control Clinics
Arm Type
Placebo Comparator
Arm Description
Subjects are mailed informational/educational materials.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigator matched with subject
Intervention Description
Subject is matched with a patient navigator. The patient navigator calls the patient. The amount of time between the abnormal test and treatment will be measured.
Intervention Type
Behavioral
Intervention Name(s)
Subjects are mailed informational/educational materials
Intervention Description
Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.
Primary Outcome Measure Information:
Title
Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment
Description
How much time exist between an abnormal test diagnosis for breast, cervical or colon or rectum cancer to when the needed follow up tests or treatment is done.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Number of barriers and effect of barriers on receiving needed tests and treatment
Description
List of and number of barriers and qualitatively how they influence a person's reasons for not getting a needed screening test or treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electra D Paskett, PhD
Organizational Affiliation
The Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27432417
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.
Results Reference
derived
PubMed Identifier
26438146
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.
Results Reference
derived
PubMed Identifier
26348120
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.
Results Reference
derived
PubMed Identifier
25071111
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.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
Jamesline
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