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Breast CancerPhase 4NCT00496678

Trial of Patient Navigation-Activation

A Phase 4 study testing Navigation in people with Breast Cancer and Colorectal Cancer, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Colorectal Cancer
What is being tested?
Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteUnited States
Study dates
Apr 2007to Aug 2010
Phase
Phase 4
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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: RCT of Primary Care-based Patient Navigation-Activation

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.

Read the 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.

Being tested
Navigation, Standard of Care
Keywords
PNRP, navigation, navigator, activation, disparities, randomized control trial, primary care, racial and ethnic minorities
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavigationBehavioural

    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

  • Standard of CareBehavioural

    Cancer patients receive standard of care for their cancer treatment

Study groups in NCT00496678
Study groupRoleWhat they receive
NavigationExperimentalNavigation through the cancer care system is the intervention
Receives: Behavioral: Navigation
Standard of CareActive comparatorCancer patient receives standard of care.
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (1)

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionJun 2010
  4. Study completionAug 2010

Resources

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 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496678
Sponsor's protocol ID
RO1U01CA116924
Status last verified
Dec 2007
First submitted
3 Jul 2007
Last updated
9 Aug 2013
Results posted
No
Data monitoring committee
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 27432417

  • 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.

    PubMed 26438146

  • 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.

    PubMed 26348120

  • 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.

    PubMed 25071111

  • 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.

    PubMed 20939928

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Navigation in people with Breast Cancer and Colorectal Cancer, run by University of Rochester 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 4 inclusion and 8 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 9 Aug 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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). 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 NCT00496678, which also lists 5 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 9 Aug 2013.

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