Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/21/2017 |
| Start Date: | October 2006 |
| End Date: | December 2010 |
Cancer Prevention and Treatment Among African American Older Adults
The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6
sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,
Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration
(September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce
disparities in cancer treatment among seniors from U.S. racial and ethnic minority
populations. Each site will focus on a specific racial/ethnic minority group, and
collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening
Assessment (CSA) will be administered at baseline to all participants in the demonstration.
Participant identification, randomization, and intervention implementation will be
standardized across sites.
Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in
collaboration with the Baltimore City Community Health Coalition is designed to address
persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment.
Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control
demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in
intensity to improve continuity and outcomes of care among African Americans seniors. 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?
Study Population: We will recruit African Americans, age 65 years or older, and currently
enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its
population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have
Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty
guideline, and 55.6% are African American.)
The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or
lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer
Screening Assessment (CSA). They will then be randomized to receive a less intensive or more
intensive intervention. The less intensive group will receive general information about
cancer and Medicare covered services and instructions to discuss the information with their
primary care doctor. The more intensive group will receive the same information as the less
intensive group receives, plus tailored facilitation services delivered by a
nurse-supervised community health worker. The primary outcome variable for the trial will be
the difference between randomized groups in adherence to treatment for breast, cervix,
colon/rectum, prostate and lung cancer.
A community advisory committee will guide all aspects of the study and will include
important stake holders (both public and private sectors), representatives from the
Baltimore City Community Health Coalition, the Baltimore City Department of Health, the
Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care
providers (physicians, oncologists, nurse practitioners, physician assistants, nurses,
social workers, pathologists) and academicians.
sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ,
Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration
(September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce
disparities in cancer treatment among seniors from U.S. racial and ethnic minority
populations. Each site will focus on a specific racial/ethnic minority group, and
collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening
Assessment (CSA) will be administered at baseline to all participants in the demonstration.
Participant identification, randomization, and intervention implementation will be
standardized across sites.
Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in
collaboration with the Baltimore City Community Health Coalition is designed to address
persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment.
Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control
demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in
intensity to improve continuity and outcomes of care among African Americans seniors. 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?
Study Population: We will recruit African Americans, age 65 years or older, and currently
enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its
population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have
Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty
guideline, and 55.6% are African American.)
The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or
lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer
Screening Assessment (CSA). They will then be randomized to receive a less intensive or more
intensive intervention. The less intensive group will receive general information about
cancer and Medicare covered services and instructions to discuss the information with their
primary care doctor. The more intensive group will receive the same information as the less
intensive group receives, plus tailored facilitation services delivered by a
nurse-supervised community health worker. The primary outcome variable for the trial will be
the difference between randomized groups in adherence to treatment for breast, cervix,
colon/rectum, prostate and lung cancer.
A community advisory committee will guide all aspects of the study and will include
important stake holders (both public and private sectors), representatives from the
Baltimore City Community Health Coalition, the Baltimore City Department of Health, the
Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care
providers (physicians, oncologists, nurse practitioners, physician assistants, nurses,
social workers, pathologists) and academicians.
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.
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
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