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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cervical Cancer Prostate Cancer Colorectal Cancer Lung Cancer Other: Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : October 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Intervention Details:
  • Other: Navigation
    Navigation and escourt

Primary Outcome Measures :
  1. subject satisfaction with navigation [ Time Frame: 7/2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379782

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United States, Hawaii
Molokai General Hospital
Kaunakakai, Hawaii, United States, 96748
Sponsors and Collaborators
Queen's Medical Centre
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Principal Investigator: Clayton Chong, MD Molokai General Hospital/Queen's Medical Center
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Responsible Party: Clayton Chong MD, Debbie Wong RN, Queen's Medical Center Identifier: NCT00379782    
Other Study ID Numbers: RA-2006-025
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Colorectal Neoplasms
Uterine Cervical Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases