Colorectal CancerNCT00265720
Colorectal Cancer Screening Intervention Trial
A study testing Reduced out of pocket expense, one on one education and Group education in people with Colorectal Cancer and Colorectal Cancer Screening, run by Morehouse School of Medicine at 1 site in United States.
Trial summary
Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Screening
- What is being tested?
- Reduced out of pocket expense, one on one education and Group education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jul 2007
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Previously not screened for colorectal cancer according to ACS guidelines
- Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
- 50 years of age or older
Who cannot join
- Non-African American
- Less than 50 years of age
- Previously screened consistent with ACS guideline
Trial locations and contacts
1 site in 1 country.
United States1 site
Morehouse School of Medicine
Atlanta, Georgia, 30310-1495
About this study
Official title: Research on Community Cancer Control: Study of Colorectal Cancer Screening in the African American Population
Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening
Read the detailed description
Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.
The purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.
Participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.
- Conditions
- Colorectal Cancer, Colorectal Cancer Screening
- Being tested
- Control, Reduced out of pocket expense, one on one education, Group education
- Keywords
- African Americans, Colorectal Cancer Screening, Colorectal Cancer, Colorectal Cancer and African Americans, Cancer Disparities
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Written materials only
Reduced out of pocket expenseOther
Reimbursed up to $500 out of pocket expense for CRC screening
one on one educationBehavioural
one on one education with a health educator
Group educationBehavioural
Education in a small group
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Written materials only Receives: Other: Control |
| Reduced out-of-pocket expense | Experimental | Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening Receives: Other: Reduced out of pocket expense |
| One-on-one education | Experimental | Individual education with a health educator on CRC screening Receives: Behavioral: one on one education |
| Group Education | Experimental | Education on CRC screening in a small group with a health educator Receives: Behavioral: Group education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact.
Secondary outcomes (1)
Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startMar 2003
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Daniel Blumenthal, M.D., M.P.H., Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265720
- Sponsor's protocol ID
- H57/CCH420680-05
- Other IDs
- H57/CCH420680-05
- Status last verified
- Feb 2009
- First submitted
- 13 Dec 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Community Cancer Control: Study of Colorectal Cancer Screening in the African American Population
- ClinicalTrials.gov ID
- NCT00265720
- Acronym / sponsor ID
- H57/CCH420680-05
- Conditions
- Colorectal Cancer, Colorectal Cancer Screening
- Keywords
- African Americans, Colorectal Cancer Screening, Colorectal Cancer, Colorectal Cancer and African Americans, Cancer Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Dec 2005 (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.
Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening
Detailed description
Despite increased awareness of the importance of being screened for colorectal cancer, African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening Intervention Trial (CCSIT) is designed to test and expand a public health intervention that combines social marketing and community-coalition building efforts.
The purpose of this study is to 1) evaluate the effects of three different approaches on knowledge, attitudes and beliefs (KABs) about colorectal cancer; 2) to examine the effects of three different approaches to adherence to screening guidelines and 3) to evaluate the independent role of setting on screening practices.
Participants age 50 and over are recruited from churches, clinics and senior sites which allows us to examine the impact of setting on participant recruitment and changes to KAB. Pre and post questionnaires are administered to determine the knowledge attitudes and behaviors (KAB) related to screening and to measure psychosocial parameters (self-esteem, perceived stress and social support). These persons are randomized into one of four groups, the control group and three intervention arms: (1) one-on-one counseling sessions, (2) small group educational sessions and (3) financial incentives interventions where out of pocket cost for screening is reimbursed. The counseling and educational interventions incorporate the Health Belief Model and Social Learning Theory.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlWritten materials only |
| Reduced out-of-pocket expense | Experimental | Other: Reduced out of pocket expenseReimbursed up to $500 out-of-pocket expense for colorectal cancer screening |
| One-on-one education | Experimental | Behavioral: one on one educationIndividual education with a health educator on CRC screening |
| Group Education | Experimental | Behavioral: Group educationEducation on CRC screening in a small group with a health educator |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American
- Previously not screened for colorectal cancer according to ACS guidelines
- Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
- 50 years of age or older
Key exclusion criteria (3 listed)
- Non-African American
- Less than 50 years of age
- Previously screened consistent with ACS guideline
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 |
|---|---|---|
| ControlWritten materials only | Other | Control |
| Reduced out of pocket expenseReimbursed up to $500 out of pocket expense for CRC screening | Other | Reduced out-of-pocket expense |
| one on one educationone on one education with a health educator | Behavioural | One-on-one education |
| Group educationEducation in a small group | Behavioural | Group Education |
Primary outcome
Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact.
1 secondary outcome
Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions:
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 4 Feb 2009.
- Morehouse School of Medicine - Prevention Research CenterLink provided by the sponsor.
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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.
Daniel Blumenthal, M.D., M.P.H. principal investigator
Morehouse School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced out of pocket expense, one on one education and Group education in people with Colorectal Cancer and Colorectal Cancer Screening, run by Morehouse School of Medicine 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 4 inclusion and 3 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 4 Feb 2009. 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. Some participants in this study may receive a placebo. 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?
Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact.. 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 4 Feb 2009.