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Cancer Prevention and Treatment Among African American Older Adults


Phase 3
65 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer, Lung Cancer

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Trial Information

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.


Inclusion Criteria:



- Age 65 or older

- Enrolled in Medicare Part A

- Enrolled in Medicare Part B of Title XVIII of the Social Security Act

- Provided Informed Consent

- Diagnosed with breast, cervical, colorectal, prostate, or lung cancer AND 1) have not
yet begun treatment for this cancer; or 2) are currently receiving treatment or
received a last treatment within the past five years; or 3) received a last treatment
5 or more years ago but have been in remission less than 5 years; AND 4) intend to
receive cancer treatment from either Johns Hopkins Hospital (JHH) or from Johns
Hopkins Bayview Medical Center (JHBMC)

Exclusion Criteria:

- Age less than 65

- Enrollment in Medicare managed care (Part C)

- Residence in a chronic care facility or otherwise institutionalized

- Planning to move within the next year

- Unable or unwilling to give informed consent

- Another member of the household enrolled in the demonstration project

- Diagnosed with breast, cervical, colorectal, prostate, or lung cancer and received a
last treatment for this cancer 5 or more years ago and have been in remission for 5
or more years

- Currently receiving treatment or will be receiving treatment soon for a non-study
cancer

- Currently diagnosed with a non-study cancer and have not received treatment yet for
this cancer but returning for additional tests and observation

- Diagnosed with a non-study cancer and received the last treatment within the last 5
years

- Diagnosed with a non-study cancer and received the last treatment for this cancer 5
or more years ago and have been in remission less than 5 years

- Diagnosed with a non-study cancer and received the last treatment for this cancer 5
or more years ago and have been in remission for 5 or more years

- Diagnosed with a study cancer and being treated outside of Johns Hopkins Medical
Institutions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Jean G. Ford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bloomberg School of Public Health, Baltimore, Maryland, United States

Authority:

United States: Institutional Review Board

Study ID:

IRB00063

NCT ID:

NCT00509444

Start Date:

October 2006

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • Rectum Cancer
  • Cervix Cancer
  • Prostate Cancer
  • Lung Cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Uterine Cervical Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

Bloomberg School of Public HealthBaltimore, Maryland  21205