Breast CancerOPNRPNCT01569672
Ohio Patient Navigator Research Program
A study testing Patient Navigator matched with subject and Subjects are mailed informational/educational materials in people with Breast Cancer and Cervical Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Colon Cancer
- What is being tested?
- Patient Navigator matched with subject and Subjects are mailed informational/educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 941 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitively impaired
- Prior history of cancer (except for nonmelanoma of the skin)
- Living in a nursing home
- Prior navigation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43201
About this study
Official title: Ohio Patient Navigation Research Program
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.
Read the 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).
- Conditions
- Breast Cancer, Cervical Cancer, Colon Cancer, Rectal Cancer, Abnormal Breast Cancer Screening Tests, Abnormal Cervical Cancer Screening Tests
- Being tested
- Patient Navigator matched with subject, Subjects are mailed informational/educational materials
- Keywords
- Navigator
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigator matched with subjectBehavioural
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.
Subjects are mailed informational/educational materialsBehavioural
Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinic | Active comparator | 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 Receives: Behavioral: Patient Navigator matched with subject |
| Control Clinics | Placebo comparator | Subjects are mailed informational/educational materials. Receives: Behavioral: Subjects are mailed informational/educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startNov 2006
- Primary completion31 Dec 2010
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 941 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D Paskett, PhD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569672
- Sponsor's protocol ID
- OPNRP
- Other IDs
- SIRG-05-253-01, NCI-2012-00205, OSU-6100
- Acronym
- OPNRP
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2012
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27432417Wells 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.
PubMed 26438146Rodday 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.
PubMed 26348120Ko 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.
PubMed 25071111
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ohio Patient Navigation Research Program
- ClinicalTrials.gov ID
- NCT01569672
- Acronym / sponsor ID
- OPNRP / OPNRP
- Conditions
- Breast Cancer, Cervical Cancer, Colon Cancer, Rectal Cancer, Abnormal Breast Cancer Screening Tests, Abnormal Cervical Cancer Screening Tests
- Keywords
- Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 941 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Nov 2006
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinic | Active comparator | Behavioral: Patient Navigator matched with subjectPatient 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 |
| Control Clinics | Placebo comparator | Behavioral: Subjects are mailed informational/educational materialsSubjects are mailed informational/educational materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Cognitively impaired
- Prior history of cancer (except for nonmelanoma of the skin)
- Living in a nursing home
- Prior navigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigator matched with subjectSubject 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. | Behavioural | Intervention Clinic |
| Subjects are mailed informational/educational materialsSubjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured. | Behavioural | Control Clinics |
Primary outcome
Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment
Time frame: Up to one year
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.
1 secondary outcome
Number of barriers and effect of barriers on receiving needed tests and treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 27432417Battaglia 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.
- Derived from this study: PubMed 26438146Wells 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.
- Derived from this study: PubMed 26348120Rodday 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.
- Derived from this study: PubMed 25071111Ko 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.
- JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra D Paskett, PhD principal investigator
The Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator matched with subject and Subjects are mailed informational/educational materials in people with Breast Cancer and Cervical Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of time from abnormal evaluation of the breast, cervix, and colon or rectum to needed tests and treatment (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569672, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.