Breast CancerNCT00379782
Kukui Ahi Navigator Cancer Screening and Treatment Demonstration Project
A study testing Navigation in people with Breast Cancer and Cervical Cancer, run by Queen's Medical Center at 1 site in United States.
Trial summary
This Cancer Prevention and Treatment Demonstration Project funded by the Centers of Medicare and Medicaid Services awarded six sites across the United States to develop Patient Navigator Programs to eliminate disparities in the rate of preventative cancer screening and timely diagnosis and treatment of cancer for… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Prostate Cancer
- What is being tested?
- Navigation
- How many people
- 628 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: No medicare managed care or hospice beneficiaries, no other cancers other than target within 5 years remission.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This Cancer Prevention and Treatment Demonstration Project funded by the Centers of Medicare and Medicaid Services awarded six sites across the United States to develop Patient Navigator Programs to eliminate disparities in the rate of preventative cancer screening and timely diagnosis and treatment of cancer for racial and ethnic minorities. This site of Molokai General Hospital are focused on Pacific Islanders and Asian Americans. This program called Kukui Ahi propose to increase screening and early detection for four targeted cancers-breast, cervical, colorectal, and prostate- with lung cancer additionally being included in treatment protocols to improve outcomes and satisfaction by employing a culturally appropriate navigation protocol to facilitate utilization of healthcare services and decrease health barriers.
The specific aims of the project is to:
- Determine if a Navigator Program can reduce the proportion of the targeted cancers diagnosed at a late stage,
- Determine if the Navigator Program can improve the continuity of health care for cancer patients,
- Determine if the Navigator Program can improve quality of life and subjective well being of navigated cancer patients,
- Determine if the Navigator Program is a cost-effective way to reduce cancer care disparities for screenable cancers.
Read the detailed description
To be eligible, patients must have Medicare parts A and B, not enrolled in a managed care plan, not enrolled in hospice, and if currently have cancer, it must be either breast, cervical, colorectal, lung, or prostate. Patients may be enrolled up to 3 ½ years. After informed consent is obtained, the navigator will administer a CSA triage (attached) to determine if patient has cancer or not. Patients who have never had cancer or been in remission for five years are eligible for the screening arm and then will have the Screening CSA (attached) performed. Cancer screening arm of the study will then go into randomization.
Medistat has created a data entry system for randomization via internet. Medstat will create site administrators and CMS staff users. All users have a defined role that controls what they can see and do. Site administrators can perform all functions and create site staff users. Site staff users can only assign protocols. All users must supply a user identification and password to gain access to the site. Patients are qualified for the demonstration by site staff. Cancer status is ascertained via CSA. Sites will assign patient identification number that will be entered along with cancer status onto the website, no personal identification. RTI will then perform randomization protocol determination and log into database. Site reports available by sight only include individual protocol assignments by patient identification number, summarized protocol assignments by site and year, and view all individual assignments made within a time window. Only the site administrator can disenroll patients. RTI will be utilizing block randomization by site and arm (screening/treatment) in even blocks of 10-18 events depending on size of site.
The patients that are in the screening intervention group will have the navigational services. The control group will receive only nutritional education. Those patients who have non-study cancers and are not in remission for five years are ineligible for the study. The study cancers will be given a treatment CSA (attached). For those patients with study cancer, the patients will automatically be put in the navigational group. Molokai being such a small community where everyone knows everyone, it was agreed that to have a control group here would appear to be withholding care and cause bias. The control group will come from another community of similar demographics of Kahuku. Both navigational groups will have an initial CSA, annual CSA, and then an exit CSA conducted in the last six months of the program. CMS has not issued the annual or exit CSA at this time. Molokai has agreed to provide no more than 578 patients with delivery of navigational services to no more than 289 patients in the screening arm of the project.
Randomization to intervention or control group will be done as above per RTI International, a statistical firm contracted by CMS. Twenty-five cancer or treatment patients will be enrolled for navigational arm on Molokai and 25 control group patients from a neighboring island.
- Conditions
- Breast Cancer, Cervical Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer
- Being tested
- Navigation
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationOther
Navigation and escourt
What is being measured
The primary outcome is the main question the study is designed to answer.
subject satisfaction with navigation
Measured: 7/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Clayton Chong, MD, Principal investigator, Molokai General Hospital/Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379782
- Sponsor's protocol ID
- RA-2006-025
- Status last verified
- May 2011
- First submitted
- 20 Sep 2006
- Last updated
- 30 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kukui Ahi Navigator Cancer Screening and Treatment Demonstration Project
- ClinicalTrials.gov ID
- NCT00379782
- Acronym / sponsor ID
- RA-2006-025
- Conditions
- Breast Cancer, Cervical Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Sep 2006 (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.
This Cancer Prevention and Treatment Demonstration Project funded by the Centers of Medicare and Medicaid Services awarded six sites across the United States to develop Patient Navigator Programs to eliminate disparities in the rate of preventative cancer screening and timely diagnosis and treatment of cancer for racial and ethnic minorities. This site of Molokai General Hospital are focused on Pacific Islanders and Asian Americans. This program called Kukui Ahi propose to increase screening and early detection for four targeted cancers-breast, cervical, colorectal, and prostate- with lung cancer additionally being included in treatment protocols to improve outcomes and satisfaction by employing a culturally appropriate navigation protocol to facilitate utilization of healthcare services and decrease health barriers.
The specific aims of the project is to:
- Determine if a Navigator Program can reduce the proportion of the targeted cancers diagnosed at a late stage,
- Determine if the Navigator Program can improve the continuity of health care for cancer patients,
- Determine if the Navigator Program can improve quality of life and subjective well being of navigated cancer patients,
- Determine if the Navigator Program is a cost-effective way to reduce cancer care disparities for screenable cancers.
Detailed description
To be eligible, patients must have Medicare parts A and B, not enrolled in a managed care plan, not enrolled in hospice, and if currently have cancer, it must be either breast, cervical, colorectal, lung, or prostate. Patients may be enrolled up to 3 ½ years. After informed consent is obtained, the navigator will administer a CSA triage (attached) to determine if patient has cancer or not. Patients who have never had cancer or been in remission for five years are eligible for the screening arm and then will have the Screening CSA (attached) performed. Cancer screening arm of the study will then go into randomization.
Medistat has created a data entry system for randomization via internet. Medstat will create site administrators and CMS staff users. All users have a defined role that controls what they can see and do. Site administrators can perform all functions and create site staff users. Site staff users can only assign protocols. All users must supply a user identification and password to gain access to the site. Patients are qualified for the demonstration by site staff. Cancer status is ascertained via CSA. Sites will assign patient identification number that will be entered along with cancer status onto the website, no personal identification. RTI will then perform randomization protocol determination and log into database. Site reports available by sight only include individual protocol assignments by patient identification number, summarized protocol assignments by site and year, and view all individual assignments made within a time window. Only the site administrator can disenroll patients. RTI will be utilizing block randomization by site and arm (screening/treatment) in even blocks of 10-18 events depending on size of site.
The patients that are in the screening intervention group will have the navigational services. The control group will receive only nutritional education. Those patients who have non-study cancers and are not in remission for five years are ineligible for the study. The study cancers will be given a treatment CSA (attached). For those patients with study cancer, the patients will automatically be put in the navigational group. Molokai being such a small community where everyone knows everyone, it was agreed that to have a control group here would appear to be withholding care and cause bias. The control group will come from another community of similar demographics of Kahuku. Both navigational groups will have an initial CSA, annual CSA, and then an exit CSA conducted in the last six months of the program. CMS has not issued the annual or exit CSA at this time. Molokai has agreed to provide no more than 578 patients with delivery of navigational services to no more than 289 patients in the screening arm of the project.
Randomization to intervention or control group will be done as above per RTI International, a statistical firm contracted by CMS. Twenty-five cancer or treatment patients will be enrolled for navigational arm on Molokai and 25 control group patients from a neighboring island.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: No medicare managed care or hospice beneficiaries, no other cancers other than target within 5 years remission.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NavigationNavigation and escourt | Other | – |
Primary outcome
subject satisfaction with navigation
Time frame: 7/2010
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 30 May 2011.
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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.
Clayton Chong, MD principal investigator
Molokai General Hospital/Queen's Medical 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 Navigation in people with Breast Cancer and Cervical Cancer, run by Queen's 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 2 inclusion and 0 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 30 May 2011. 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.
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?
subject satisfaction with navigation (time frame: 7/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2011.