Clinical trial NCT00613275: Patient Navigation in the Safety Net:CONNECTeDD
Official title: Patient Navigation in the Safety Net:CONNECTeDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Cervical Cancer
Keywords: PNRP
Navigation
Navigator
Activation
Disparities
Primary Care
Racial and Ethnic Minorities
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 4038
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Boston University Medical Center, funded by the National Cancer Institutes will train health workers at six of its affiliated Community Health Centers 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 Cervical cancer patients. The project also will evaluate whether navigation improves the ability to communicate with the doctor, satisfaction with patient's care and quality of life.

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 engagement 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 patient Navigators who work within one of the six affiliated Community Health Centers. 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.

Eligibility criteria: Inclusion Criteria:

* Receive care at one of the 6 participating community Health centers
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Develop,implement and evaluate a primary care-based,patient navigation program using patient navigators in the Community Health Centers. We will investigate the effect of this intervention on timing and quality of cancer-related care
timeFrame: 4 years
Secondary outcomes:
measure: Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Karen M Freund, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Tracy Battaglia, MD, MPH
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.