Partnership for Healthy Seniors
Primary Purpose
Breast Cancer, Colon Cancer, Rectum Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health coordinator (or patient navigator)
Educational materials only
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
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 years
Sites / Locations
- Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
2
Arm Description
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.
Outcomes
Primary Outcome Measures
Difference between the two intervention groups in the proportion of participants who complete at least one of the recommended screenings.
Secondary Outcome Measures
Adherence to maintenance screening.
Timely notification of abnormal screening results.
Timely follow up with specialist following abnormal screening result.
Timely diagnosis following abnormal result.
Timely treatment start-up.
Improved utilization of Medicare-covered preventive services.
Stage at diagnosis.
Full Information
NCT ID
NCT00379743
First Posted
September 20, 2006
Last Updated
April 24, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Medicare and Medicaid Services
1. Study Identification
Unique Protocol Identification Number
NCT00379743
Brief Title
Partnership for Healthy Seniors
Official Title
Cancer Prevention and Treatment Among African American Older Adults: Screening Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Centers for Medicare and Medicaid Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer, Rectum Cancer, Cervix Cancer, Prostate Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2593 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health coordinator (or patient navigator)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials only
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Adherence to maintenance screening.
Time Frame
Number of days beyond extended window for completion of a specific screening test
Title
Timely notification of abnormal screening results.
Time Frame
Number of days between detection of an abnormal screening result and participant notification about the results
Title
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
Title
Timely diagnosis following abnormal result.
Time Frame
From date of detection of an abnormal screening result to date of diagnosis
Title
Timely treatment start-up.
Time Frame
Number of days from the date of diagnosis to date of initiation of therapy
Title
Improved utilization of Medicare-covered preventive services.
Time Frame
From date of randomization to date of completion of participation in the study
Title
Stage at diagnosis.
Time Frame
At the time of diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Dobs, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23629519
Citation
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.
Results Reference
derived
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Partnership for Healthy Seniors
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