Breast CancerPhase 4NCT00613275
Patient Navigation in the Safety Net:CONNECTeDD
A Phase 4 study testing patient Navigation in people with Breast Cancer and Cervical Cancer, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- patient Navigation
- How many people
- 4,038 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Sep 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 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.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- patient Navigation
- Keywords
- PNRP, Navigation, Navigator, Activation, Disparities, Primary Care, Racial and Ethnic Minorities
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient NavigationOther
Assigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (1)
Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJul 2005
- Primary completionJun 2010
- Study completionSep 2011
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.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Battaglia, Tracy, Boston Medical Center
- Investigators
- Karen M Freund, MD, MPH, Principal investigator, Boston Medical CenterTracy Battaglia, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613275
- Sponsor's protocol ID
- U01CA116892-03
- Other IDs
- U01CA116892
- Status last verified
- Jun 2016
- First submitted
- 30 Jan 2008
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation in the Safety Net:CONNECTeDD
- ClinicalTrials.gov ID
- NCT00613275
- Acronym / sponsor ID
- U01CA116892-03
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- PNRP, Navigation, Navigator, Activation, Disparities, Primary Care, Racial and Ethnic Minorities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,038 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Feb 2008 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 NavigationAssigning a patient navigator to patients with abnormal breast and cervical cancer screening results at one of 6 affiliated community health centers | Other | – |
Primary outcome
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
Time frame: 4 years
1 secondary outcome
Secondary aims examine the impact of navigation on disparities in care, improvement in patient activation and total costs
Time frame: 4 years
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 15 Jun 2016.
- 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.
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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.
Karen M Freund, MD, MPH principal investigator
Boston Medical Center
Tracy Battaglia, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing patient Navigation in people with Breast Cancer and Cervical Cancer, run by Boston Medical 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 4 inclusion and 5 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 15 Jun 2016. 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?
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 (time frame: 4 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 NCT00613275, 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 15 Jun 2016.