CancerNCT00385866
Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries
A study testing cancer screening and health education and facilitation of Services to improve cancer screening in people with Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- cancer screening and health education and facilitation of Services to improve cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cancer-Negative Group
- Be of Hispanic/Latino Origin
- Fluent in English and/or Spanish
- Recipient of, Medicare Part A \& B, or combined Medicare/Medicaid
- Not having a previous diagnosis of cancer
- Be capable of giving written informed consent prior to any study related procedures.
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- Be available and willing to complete all study assessments as specified.
- Cancer-Positive Group
- Be of Hispanic/Latino Origin
- Fluent in English and/or Spanish
- Recipient of, Medicare Part A \& B, or combined Medicare/Medicaid
- Having a previous diagnosis of cancer of the breast, cervix, colon and/or rectum, prostate, or lung.
- Be capable of giving written informed consent prior to any study related procedures.
- Be available and willing to complete all study assessments as specified.
Who cannot join
- Member of the Medicare Advantage Plan, any Medicare managed care plan (Those who join the Medicare Advantage plan or a managed care plan during the course of the study will become ineligible to continue.)
- Medicaid only beneficiaries
- Institutionalized
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.
Read the detailed description
The Latino population is the fastest growing minority population in the United States . Cancer ranks as the second leading cause of death among Latinos in the United States (24%), second only to heart disease . This project will evaluate whether an innovative facilitation program (targeting cancers of the prostate, colon/rectum, breast, and cervix) will improve cancer outcomes among Latino Medicare beneficiaries in the city of Newark, New Jersey.
The overall aim of this project is to institute an innovative cancer care facilitation program for elderly Latinos in the city of Newark, NJ. The goal is to reduce the disparities observed in screening, time to diagnosis and treatment services, by utilizing a multidisciplinary team approach to health care, incorporating systems thinking methodology. Using the Multilevel Approach to Community Health (MATCH) planning model , the program will incorporate community outreach, education, and access to screening, and patient assistance in all aspects of the health care continuum. It will also include cultural and linguistic competency training for all those involved in the facilitation process. To accomplish this goal, we propose four objectives:
- To establish a multidisciplinary team that will utilize a systems thinking approach to design and structure the delivery of cancer screening, diagnosis and treatment facilitation services.
- To build a collaborative consortium between program partners to improve screening outcomes, that will encourage the utilization of services in the community.
- To improve the delivery of cancer prevention and treatment facilitation by providing cultural and linguistic competency training to the multidisciplinary team, providers, and the community.
- To demonstrate the effectiveness of the intervention in reducing the burden of cancer, by increasing screening rates, improving time to diagnosis and delivery of treatment services, patient satisfaction, and appropriate use of Medicare services.
- Conditions
- Cancer
- Being tested
- cancer screening and health education, facilitation of Services to improve cancer screening
- Keywords
- Patient Navigator, Community health, Communication
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cancer screening and health educationBehavioural
Also called patient navigation, cancer screening and education
The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.
facilitation of Services to improve cancer screeningBehavioural
Also called patient navigation, faciliation of services, screening
The intervention group will receive cancer education and faciliation of services in the form of patient navigation
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group | Active comparator | The control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no facilitation of services. Receives: Behavioral: cancer screening and health education |
| Intervention group | Active comparator | The intervention group are those participants who were randomly assigned to receive facilitation of services in the form of patient navigation for the duration of the study. Receives: Behavioral: cancer screening and health education; Behavioral: facilitation of Services to improve cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the disparities observed in utilization of cancer screening services
Measured: 2-4 years
Secondary outcomes (2)
Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care
Measured: 4 years
Improve patient satisfaction and informed decision making.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 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 CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Ana Natale-Pereira, MD, MPH, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385866
- Sponsor's protocol ID
- 0120060236
- Status last verified
- Apr 2016
- First submitted
- 10 Oct 2006
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries
- ClinicalTrials.gov ID
- NCT00385866
- Acronym / sponsor ID
- 0120060236
- Conditions
- Cancer
- Keywords
- Patient Navigator, Community health, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,272 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Oct 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Oct 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.
To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.
Detailed description
The Latino population is the fastest growing minority population in the United States . Cancer ranks as the second leading cause of death among Latinos in the United States (24%), second only to heart disease . This project will evaluate whether an innovative facilitation program (targeting cancers of the prostate, colon/rectum, breast, and cervix) will improve cancer outcomes among Latino Medicare beneficiaries in the city of Newark, New Jersey.
The overall aim of this project is to institute an innovative cancer care facilitation program for elderly Latinos in the city of Newark, NJ. The goal is to reduce the disparities observed in screening, time to diagnosis and treatment services, by utilizing a multidisciplinary team approach to health care, incorporating systems thinking methodology. Using the Multilevel Approach to Community Health (MATCH) planning model , the program will incorporate community outreach, education, and access to screening, and patient assistance in all aspects of the health care continuum. It will also include cultural and linguistic competency training for all those involved in the facilitation process. To accomplish this goal, we propose four objectives:
- To establish a multidisciplinary team that will utilize a systems thinking approach to design and structure the delivery of cancer screening, diagnosis and treatment facilitation services.
- To build a collaborative consortium between program partners to improve screening outcomes, that will encourage the utilization of services in the community.
- To improve the delivery of cancer prevention and treatment facilitation by providing cultural and linguistic competency training to the multidisciplinary team, providers, and the community.
- To demonstrate the effectiveness of the intervention in reducing the burden of cancer, by increasing screening rates, improving time to diagnosis and delivery of treatment services, patient satisfaction, and appropriate use of Medicare services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group | Active comparator | Behavioral: cancer screening and health educationThe control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no facilitation of services. |
| Intervention group | Active comparator | Behavioral: cancer screening and health education, Behavioral: facilitation of Services to improve cancer screeningThe intervention group are those participants who were randomly assigned to receive facilitation of services in the form of patient navigation for the duration of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Cancer-Negative Group
- Be of Hispanic/Latino Origin
- Fluent in English and/or Spanish
- Recipient of, Medicare Part A \& B, or combined Medicare/Medicaid
- Not having a previous diagnosis of cancer
Key exclusion criteria (4 listed)
- Member of the Medicare Advantage Plan, any Medicare managed care plan (Those who join the Medicare Advantage plan or a managed care plan during the course of the study will become ineligible to continue.)
- Medicaid only beneficiaries
- Institutionalized
- Unable to provide written 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 |
|---|---|---|
| cancer screening and health educationAlso: patient navigation, cancer screening and educationThe control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services. | Behavioural | Comparison Group, Intervention group |
| facilitation of Services to improve cancer screeningAlso: patient navigation, faciliation of services, screeningThe intervention group will receive cancer education and faciliation of services in the form of patient navigation | Behavioural | Intervention group |
Primary outcome
Reduce the disparities observed in utilization of cancer screening services
Time frame: 2-4 years
2 secondary outcomes
Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care
Time frame: 4 years
Improve patient satisfaction and informed decision making.
Time frame: 4 years
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 2016.
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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.
Ana Natale-Pereira, MD, MPH principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cancer screening and health education and facilitation of Services to improve cancer screening in people with Cancer, run by University of Medicine and Dentistry of New Jersey 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 14 inclusion and 4 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 2016. 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?
Reduce the disparities observed in utilization of cancer screening services (time frame: 2-4 years). 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 2016.