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Kukui Ahi Navigator Cancer Screening and Treatment Demonstration Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379782
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : May 30, 2011
Information provided by:
Queen's Medical Centre

Tracking Information
First Submitted Date  ICMJE September 20, 2006
First Posted Date  ICMJE September 22, 2006
Last Update Posted Date May 30, 2011
Study Start Date  ICMJE October 2006
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
subject satisfaction with navigation [ Time Frame: 7/2010 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Kukui Ahi Navigator Cancer Screening and Treatment Demonstration Project
Official Title  ICMJE Not Provided
Brief 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 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:

  1. Determine if a Navigator Program can reduce the proportion of the targeted cancers diagnosed at a late stage,
  2. Determine if the Navigator Program can improve the continuity of health care for cancer patients,
  3. Determine if the Navigator Program can improve quality of life and subjective well being of navigated cancer patients,
  4. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Breast Cancer
  • Cervical Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Lung Cancer
Intervention  ICMJE Other: Navigation
Navigation and escourt
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 20, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Medicare Part A & B beneficiaries -

Exclusion Criteria: No medicare managed care or hospice beneficiaries, no other cancers other than target within 5 years remission.


Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00379782
Other Study ID Numbers  ICMJE RA-2006-025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clayton Chong MD, Debbie Wong RN, Queen's Medical Center
Study Sponsor  ICMJE Queen's Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clayton Chong, MD Molokai General Hospital/Queen's Medical Center
PRS Account Queen's Medical Centre
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP