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Cancer Prevention and Treatment Among African American Older Adults: Screening Trial

Phase 3
65 Years
Open (Enrolling)
Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer

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Trial Information

Cancer Prevention and Treatment Among African American Older Adults: Screening Trial

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 cancer screening
recommendations among those who are not known to have cancer?


The Centers for Medicare and Medicaid Services (CMS) received congressional authorization to
launch a nationwide demonstration project to address persistent disparities in cancer
prevention 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 screening among African American seniors residing in


This demonstration project will evaluate the efficacy of a health coordinator model in
cancer screening for older African American adults in Baltimore, Maryland.

We will conduct A RANDOMIZED CONTROLLED TRIAL testing the efficacy of the model intervention
in facilitating screening services for individuals who are not known to have cancer. The
duration of follow-up post-randomization will be from date of randomization and September
30th, 2010, the end date for the demonstration.

We will 1) implement a population-based recruitment strategy in tandem with convenience
sampling, targeting African American Medicare enrollees who reside in Baltimore, and are not
known to have cancer; and 2) conduct a randomized controlled trial comparing 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 cancer screening.

The null hypothesis to be tested in this trial is that "the proportion of participants in
the more intensive intervention group who complete at least one of the recommended
screenings is equal to that of participants in the less intensive intervention group."

The primary outcome variable for the trial will be the difference between the two
intervention groups in the proportion of participants who complete at least one of the
recommended screenings.

Population: A total of 2874 study participants will be accrued from the Medicare enrollment
database, which will be stratified by gender and age (65-74 year olds and 75 plus years).

The study population will consist of older African American Medicare beneficiaries who
reside in Baltimore. The sampling frame will be restricted to African American Medicare
beneficiaries, age 65 and older, Baltimore residents 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;

- Residence in Baltimore;

- Enrolled in Medicare Part A;

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

- Provided informed consent;

- Must be free from cancer or in remission for 5 years or more

Exclusion Criteria:

- Age less than 65;

- Residence outside of Baltimore;

- 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;

- Diagnosed with cancer within 5 years or less;

- Diagnosed with cancer more than 5 years ago, but cancer in remission for less than 5

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.

Outcome Time Frame:

Number of days from date of randomization to date of completion of participation in the study

Safety Issue:


Principal Investigator

Jean G. Ford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bloomberg School of Public Health


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

December 2012

Related Keywords:

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



Bloomberg School of Public Health Baltimore, Maryland  21205