Prostate CancerNCT00380055
Reducing Cancer Disparities for American Indians in the Rural Intermountain West
A study testing Navigation Services and Cancer education in people with Prostate Cancer and Colorectal Cancer, run by University of Utah at 2 sites in United States.
Trial summary
The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Colorectal Cancer, Breast Cancer
- What is being tested?
- Navigation Services and Cancer education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 2 sitesUnited 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
- Enrolled in Medicare Part B
- Self-reported American Indian
Who cannot join
- Have cancer other than study cancer
- Medicare Part C enrolled
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sletten Cancer Institute
Great Falls, Montana, 59405
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.
Read the detailed description
Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.
- Conditions
- Prostate Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer, Lung Cancer
- Being tested
- Navigation Services, Cancer education
- Keywords
- Cancer Screening, Navigators, Community Outreach, Behavioral Change, Access
- Medical subject headings
- Prostatic Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation ServicesBehavioural
Navigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care.
Cancer educationBehavioural
Community health workers provide cancer education appropriate for Medicare participants.
| Study group | Role | What they receive |
|---|---|---|
| Screening Navigation | Experimental | Individuals without a study cancer who receive services of a navigator. Receives: Behavioral: Navigation Services |
| Treatment Navigation | Experimental | Individuals with a study cancer who receive navigation services. Receives: Behavioral: Navigation Services |
| Screening Education | Active comparator | Rather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees. Receives: Behavioral: Cancer education |
| Treatment Education | Active comparator | Rather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients. Receives: Behavioral: Cancer education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.
Measured: four years
Secondary outcomes (3)
Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.
Measured: four years
Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.
Measured: four years
Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 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.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Sletten Cancer Institute, Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, Randall W. Rupper, University of Utah
- Investigators
- Randall W. Burt, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380055
- Sponsor's protocol ID
- 18388
- Other IDs
- 1A0CMS300067
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2006
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cancer Disparities for American Indians in the Rural Intermountain West
- ClinicalTrials.gov ID
- NCT00380055
- Acronym / sponsor ID
- 18388
- Conditions
- Prostate Cancer, Colorectal Cancer, Breast Cancer, Cervical Cancer, Lung Cancer
- Keywords
- Cancer Screening, Navigators, Community Outreach, Behavioral Change, Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Sletten Cancer Institute, Centers for Medicare and Medicaid Services
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 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 purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.
Detailed description
Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Screening Navigation | Experimental | Behavioral: Navigation ServicesIndividuals without a study cancer who receive services of a navigator. |
| Treatment Navigation | Experimental | Behavioral: Navigation ServicesIndividuals with a study cancer who receive navigation services. |
| Screening Education | Active comparator | Behavioral: Cancer educationRather than receiving navigation, these participants receive general cancer education appropriate to Medicare enrollees. |
| Treatment Education | Active comparator | Behavioral: Cancer educationRather than receiving navigation services, these participants receive cancer education appropriate to Medicare recipients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in Medicare Part B
- Self-reported American Indian
Key exclusion criteria (2 listed)
- Have cancer other than study cancer
- Medicare Part C enrolled
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 |
|---|---|---|
| Navigation ServicesNavigators (community health workers) identify and assist in overcoming barriers to appropriate cancer care. | Behavioural | Screening Navigation, Treatment Navigation |
| Cancer educationCommunity health workers provide cancer education appropriate for Medicare participants. | Behavioural | Screening Education, Treatment Education |
Primary outcome
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer.
Time frame: four years
3 secondary outcomes
Proportion of individuals receiving recommended diagnostic follow-up for prostate, breast, colorectal, and cervical cancer.
Time frame: four years
Proportion of individuals receiving recommended treatment for prostate, breast, colorectal, cervical, and lung cancer.
Time frame: four years
Cost-effectiveness of using community navigators to improve cancer care among rural Native Americans.
Time frame: 10 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 21 Sep 2011.
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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.
Randall W. Burt, MD principal investigator
Huntsman Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation Services and Cancer education in people with Prostate Cancer and Colorectal Cancer, run by University of Utah at 2 sites 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 2 inclusion and 2 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 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of individuals receiving recommended screening for prostate, breast, colorectal, and cervical cancer. (time frame: four 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 21 Sep 2011.