Breast CancerNCT00379743
Partnership for Healthy Seniors
A study testing Health coordinator (or patient navigator) and Educational materials only 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 olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colon Cancer, Rectum Cancer
- What is being tested?
- Health coordinator (or patient navigator) and Educational materials only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,593 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 years
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: Screening Trial
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 screening 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 screening for breast, cervix, colon/rectum and prostate cancer among Baltimore City's seniors.
Read more
Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project, 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 cancer screening recommendations among those who are not known to have cancer?
Study Population: We will recruit African American residents of Baltimore, 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.)
Eligible participants will respond to a baseline questionnaire, 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 will be the difference between randomized groups in adherence to screening for breast, cervix, colon/rectum and prostate 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 cancer screening recommendations among those who are not known to have 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 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 Baltimore.
Aim
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.
- Conditions
- Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer
- Being tested
- Health coordinator (or patient navigator), Educational materials only
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coordinator (or patient navigator)Behavioural
Individuals randomized to receive the less intensive intervention receive educational materials only. Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer. The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services.
Educational materials onlyBehavioural
A brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Individuals randomized to this arm receive the following interventions: 1) educational materials on recommended cancer-preventive services, plus 2) a health coordinator (patient navigator) who helps the participant schedule and keep appointments for cancer screening and/or treatment. Receives: Behavioral: Health coordinator (or patient navigator); Behavioral: Educational materials only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.
Measured: Number of days from date of randomization to date of completion of participation in the study
Secondary outcomes (7)
Adherence to maintenance screening.
Measured: Number of days beyond extended window for completion of a specific screening test
Timely notification of abnormal screening results.
Measured: Number of days between detection of an abnormal screening result and participant notification about the results
Timely follow up with specialist following abnormal screening result.
Measured: From date of detection of an abnormal screening result to date of visit with specialist
Timely diagnosis following abnormal result.
Measured: From date of detection of an abnormal screening result to date of diagnosis
Timely treatment start-up.
Measured: Number of days from the date of diagnosis to date of initiation of therapy
Improved utilization of Medicare-covered preventive services.
Measured: From date of randomization to date of completion of participation in the study
Stage at diagnosis.
Measured: At the time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,593 participants (actual)
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
- Sponsor
- Investigators
- Adrian Dobs, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379743
- Sponsor's protocol ID
- IRB00000063
- Status last verified
- Apr 2018
- First submitted
- 20 Sep 2006
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez KA, Pollack CE, Phelan DF, Markakis D, Bone L, Shapiro G, Wenzel J, Howerton M, Johnson L, Garza MA, Ford JG. Gender differences in correlates of colorectal cancer screening among Black Medicare beneficiaries in Baltimore. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1037-42. doi: 10.1158/1055-9965.EPI-12-1215. Epub 2013 Apr 29.
PubMed 23629519
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention and Treatment Among African American Older Adults: Screening Trial
- ClinicalTrials.gov ID
- NCT00379743
- Acronym / sponsor ID
- IRB00000063
- Conditions
- Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,593 participants (actual)
- 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
- 22 Sep 2006 (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 screening 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 screening for breast, cervix, colon/rectum and prostate cancer among Baltimore City's seniors.
Primary Objective: Conduct a randomized controlled trial (target N = 2,874) within a project, 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 cancer screening recommendations among those who are not known to have cancer?
Study Population: We will recruit African American residents of Baltimore, 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.)
Eligible participants will respond to a baseline questionnaire, 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 will be the difference between randomized groups in adherence to screening for breast, cervix, colon/rectum and prostate 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 cancer screening recommendations among those who are not known to have 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 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 Baltimore.
Aim
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: Health coordinator (or patient navigator), Behavioral: Educational materials onlyIndividuals randomized to this arm receive the following interventions: 1) educational materials on recommended cancer-preventive services, plus 2) a health coordinator (patient navigator) who helps the participant schedule and keep appointments for cancer screening and/or treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Health coordinator (or patient navigator)Individuals randomized to receive the less intensive intervention receive educational materials only. Those randomized to the more intensive intervention are assigned a health coordinator (patient navigator) who delivers an enhanced, tailored educational intervention after review of the participant's screening history and knowledge gaps about cancer. The health coordinator also facilitate adherence to cancer screening and/or treatment services, by assisting in scheduling and keeping of appointments for cancer-related screening and/or treatment services. | Behavioural | 2 |
| Educational materials onlyA brochure is provided to the participant with information about preventive services covered by Medicare, and the frequency with which those services should be obtained. | Behavioural | 2 |
Primary outcome
Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.
Time frame: Number of days from date of randomization to date of completion of participation in the study
7 secondary outcomes
Adherence to maintenance screening.
Time frame: Number of days beyond extended window for completion of a specific screening test
Timely notification of abnormal screening results.
Time frame: Number of days between detection of an abnormal screening result and participant notification about the results
Timely follow up with specialist following abnormal screening result.
Time frame: From date of detection of an abnormal screening result to date of visit with specialist
Timely diagnosis following abnormal result.
Time frame: From date of detection of an abnormal screening result to date of diagnosis
Timely treatment start-up.
Time frame: Number of days from the date of diagnosis to date of initiation of therapy
Improved utilization of Medicare-covered preventive services.
Time frame: From date of randomization to date of completion of participation in the study
Stage at diagnosis.
Time frame: At the time of diagnosis
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 26 Apr 2018.
- Derived from this study: PubMed 23629519Martinez KA, Pollack CE, Phelan DF, Markakis D, Bone L, Shapiro G, Wenzel J, Howerton M, Johnson L, Garza MA, Ford JG. Gender differences in correlates of colorectal cancer screening among Black Medicare beneficiaries in Baltimore. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1037-42. doi: 10.1158/1055-9965.EPI-12-1215. Epub 2013 Apr 29.
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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.
Adrian Dobs, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coordinator (or patient navigator) and Educational materials only 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 6 inclusion and 8 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 26 Apr 2018. 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.
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?
Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings. (time frame: Number of days from date of randomization to date of completion of participation in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379743, which also lists 1 linked publication.
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 26 Apr 2018.