Cancer Prevention and Treatment Among African American Older Adults
Among African American seniors, compared to a less intensive intervention (general
information and educational materials), does the addition of facilitation services delivered
by a health coordinator result in a greater improvement in adherence to recommended
treatment among those diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer?
Background The Centers for Medicare and Medicaid Services (CMS) received congressional
authorization to launch a nationwide demonstration project to address persistent disparities
in cancer treatment among racial and ethnic minority populations. Hopkins was selected as
one of six national sites to conduct a demonstration project designed to test an
intervention strategy to promote adherence to cancer treatment.
Aim This demonstration project will evaluate the efficacy of a health coordinator model. We
will conduct A RANDOMIZED CONTROLLED TRIAL testing the efficacy of the intervention for
African American seniors diagnosed with cancer. The duration of follow-up post-randomization
will be from date of randomization and September 30th, 2010, the end date for the
demonstration.
This randomized controlled trial will compare the efficacy of a less intensive intervention
(general information and educational materials in the context of "usual care") to that of a
more intensive intervention, the addition of a health coordinator (HC), in promoting
adherence to treatment among African American seniors who have been diagnosed with breast,
cervix, colon/rectum, prostate or lung cancer.
The primary outcome variable for the trial will be the difference between the two
intervention groups in the time to initiation of therapy, beginning on the date of
randomization.
Population: The study population will consist of a convenience sample of 200 individuals
diagnosed with breast, cervix, colon, lung or prostate cancer, and who intend to receive
their cancer treatment from either Johns Hopkins Hospital (JHH) or from Johns Hopkins
Bayview Medical Center (JHBMC).
The sampling frame will be restricted to African American Medicare beneficiaries, age 65 and
older, enrolled in Medicare Parts A and B, but not enrolled in managed care (Medicare Part
C), hospice, or some other extended care facility. With a population of 651,154, African
Americans constitute 64% of Baltimore City's total population44. Additionally, 13.2% of
Baltimoreans are age 65 or older, and this accounts for 68% of the City's cancer deaths.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome variable will be difference between the two intervention groups in the time to initiation of therapy, beginning on the date of randomization.
Jean G. Ford, MD
Principal Investigator
Bloomberg School of Public Health, Baltimore, Maryland, United States
United States: Institutional Review Board
IRB00063
NCT00509444
October 2006
December 2012
Name | Location |
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Bloomberg School of Public Health | Baltimore, Maryland 21205 |