Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509444
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2007-07-27
Brief Title:
Cancer Prevention and Treatment Among African American Older Adults Treatment Trial
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Cancer Prevention and Treatment Among African American Older Adults
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPTD
Brief 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 One goal of the demonstration is to reduce disparities in cancer treatment among seniors from US racial and ethnic minority populations Each site will focus on a specific racialethnic 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 colonrectum 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 colonrectum 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 Citys 82202 seniors represent 13 of its population and account for 68 of the Citys cancer deaths Among these seniors 96 have Medicare Parts A and B 545 have income levels at less than 250 of the federal poverty guideline and 556 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 colonrectum 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
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 colonrectum 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 colonrectum 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 Citys 82202 seniors represent 13 of its population and account for 68 of the Citys cancer deaths Among these seniors 96 have Medicare Parts A and B 545 have income levels at less than 250 of the federal poverty guideline and 556 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 colonrectum 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 colonrectum 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 colonrectum 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 651154 African Americans constitute 64 of Baltimore Citys total population44 Additionally 132 of Baltimoreans are age 65 or older and this accounts for 68 of the Citys cancer deaths
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 colonrectum 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 651154 African Americans constitute 64 of Baltimore Citys total population44 Additionally 132 of Baltimoreans are age 65 or older and this accounts for 68 of the Citys cancer deaths
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None