Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00379782 |
| Other study ID # |
RA-2006-025 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 20, 2006 |
| Last updated |
May 26, 2011 |
| Start date |
October 2006 |
| Est. completion date |
March 2011 |
Study information
| Verified date |
May 2011 |
| Source |
Queen's Medical Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical 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 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.
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.
