Breast CancerPhase 3CPTDNCT00509444
Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial
A Phase 3 study testing Educational materials and educational materials, plus patient navigation in people with Breast Cancer and Colon Cancer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer, Rectum Cancer
- What is being tested?
- Educational materials and educational materials, plus patient navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer, Lung Cancer
- Being tested
- Educational materials, educational materials, plus patient navigation
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materialsBehavioural
educational materials, plus patient navigationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Educational materials | Active comparator | Not described Receives: Behavioral: Educational materials |
| Educational materials, plus patient navigation | Experimental | Not described Receives: Behavioral: educational materials, plus patient navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (4)
The time in days to the first treatment-related visit (with a medical, radiation oncologist, or surgical oncologist) beginning on the date of randomization.
The rate of completion of recommended courses of chemo and/or radiation therapy.
The proportion completing recommended surgical treatment.
The proportion receiving recommended screenings for breast, cervix, colon/rectum and prostate cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Jean Ford, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Jean G. Ford, MD, Principal investigator, Bloomberg School of Public Health, Baltimore, Maryland, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509444
- Sponsor's protocol ID
- IRB00063
- Acronym
- CPTD
- Status last verified
- Apr 2017
- First submitted
- 27 Jul 2007
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention and Treatment Among African American Older Adults
- ClinicalTrials.gov ID
- NCT00509444
- Acronym / sponsor ID
- CPTD / IRB00063
- Conditions
- Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer, Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational materials | Active comparator | Behavioral: Educational materials |
| Educational materials, plus patient navigation | Experimental | Behavioral: educational materials, plus patient navigation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational materials | Behavioural | Educational materials |
| educational materials, plus patient navigation | Behavioural | Educational materials, plus patient navigation |
Primary outcome
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.
4 secondary outcomes
The time in days to the first treatment-related visit (with a medical, radiation oncologist, or surgical oncologist) beginning on the date of randomization.
The rate of completion of recommended courses of chemo and/or radiation therapy.
The proportion completing recommended surgical treatment.
The proportion receiving recommended screenings for breast, cervix, colon/rectum and prostate cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean G. Ford, MD principal investigator
Bloomberg School of Public Health, Baltimore, Maryland, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational materials and educational materials, plus patient navigation in people with Breast Cancer and Colon Cancer, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.