Colorectal CancerPhase 3NCT00893295
Increasing Colorectal Cancer Screening in African Americans
A Phase 3 study testing informational intervention, medical chart review and screening questionnaire administration in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Finding out what affects a patient's decision to undergo screening tests may help increase the number of patients who undergo regular screening for cancer. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- informational intervention, medical chart review and screening questionnaire administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 896 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2011
- Phase
- Phase 3
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- African-American participants who receive medical care in a large, urban primary care practice setting and are eligible for colorectal cancer (CRC) screening
- Noncompliant with CRC screening in terms of American Cancer Society guidelines
- Attended an office visit within the past 2 years
PATIENT CHARACTERISTICS:
- No family history of colorectal cancer diagnosed before the age of 60 years
- No prior diagnosis of colorectal neoplasia (cancer or polyps) or inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer, 215-955-6084
About this study
Official title: Increasing Colon Cancer Screening in Primary Care Among African Americans
RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Finding out what affects a patient's decision to undergo screening tests may help increase the number of patients who undergo regular screening for cancer. It is not yet known whether personalized invitations to undergo colorectal cancer screening are more effective than standard screening reminders.
PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer screening in African Americans.
Read the detailed description
OBJECTIVES:
- To assess the intervention impact on colorectal cancer (CRC) screening utilization over a 6-month observation period in African-American participants.
- To assess the intervention impact on CRC screening preference, classified into three levels (i.e., "decided not to screen or never heard of," "undecided," or "decided to screen"), based on data obtained from both the endpoint chart audit and the endpoint survey.
- To assess intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy related to CRC screening measured with 6 to 10 Likert-type items on both the baseline and endpoint surveys.
- To analyze intervention cost-effectiveness, from the societal perspective and from the more limited perspective of the provider and payer, focusing on the average and incremental cost per additional person who is compliant (i.e., has a CRC screening test during the observation period) for each alternative intervention and estimate the cost per life-year saved.
OUTLINE: This is a multicenter study. Participants are stratified according to practice. Participants are randomized to 1 of 2 intervention arms.
- Arm I (standard-intervention group): Participants receive a personalized screening invitation letter encouraging selection and performance of one of the screening tests, a generic colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment. After 45 days, participants who have not been screened receive a reminder letter.
- Arm II (tailored-navigation intervention group): Participants receive a CRC screening invitation letter and materials that are tailored to the individual's preferred screening test strategy (i.e., SBT; SBT and instructions for arranging flexible sigmoidoscopy, instructions for arranging flexible sigmoidoscopy; or instructions for arranging colonoscopy). After 30 days, participants who have not been screened will receive a reminder by telephone. Those participants who have undergone screening will be congratulated for taking the time and preventative action, and be encouraged to continue future screenings. After 45 days, participants who have not been screened receive a reminder letter.
Participants are assessed by a baseline survey consisting of personal background, cognitive and psychological representations, social support and influence, intention, and decision stage related to screening SBT and colonoscopy preference. Data obtained from the endpoint survey assessing whether participants and their providers discussed CRC screening before the study and opinions about the intervention, and an endpoint chart audit to gather data on participant CRC screening exam dates and exam results (i.e., screening SBT, flexible sigmoidoscopy, colonoscopy, double-contrast barium enema [DCBE] x-ray) are assessed for group differences.
- Conditions
- Colorectal Cancer
- Being tested
- informational intervention, medical chart review, screening questionnaire administration, study of socioeconomic and demographic variables, barium enema injection
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informational interventionOther
medical chart reviewOther
screening questionnaire administrationOther
study of socioeconomic and demographic variablesOther
barium enema injectionProcedure or surgery
colon imaging studyProcedure or surgery
screening colonoscopyProcedure or surgery
sigmoidoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period
Secondary outcomes (2)
Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey
Intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy-related CRC screening measured with 6 to 10 Likert-type items on both the baseline and end ...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2011 (estimated)
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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 896 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald Myers, PhD, Principal investigator, Jefferson Medical College of Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893295
- Sponsor's protocol ID
- CDR0000635953
- Other IDs
- TJUH-RSGT-08-017-01-CPPB, 08G.89
- Status last verified
- Jul 2009
- First submitted
- 2 May 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Colon Cancer Screening in Primary Care Among African Americans
- ClinicalTrials.gov ID
- NCT00893295
- Acronym / sponsor ID
- CDR0000635953
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 896 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (estimated)
- First posted
- 5 May 2009 (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.
RATIONALE: Screening may help doctors find colorectal cancer sooner, when it may be easier to treat. Finding out what affects a patient's decision to undergo screening tests may help increase the number of patients who undergo regular screening for cancer. It is not yet known whether personalized invitations to undergo colorectal cancer screening are more effective than standard screening reminders.
PURPOSE: This randomized phase III trial is studying ways to increase colorectal cancer screening in African Americans.
Detailed description
OBJECTIVES:
- To assess the intervention impact on colorectal cancer (CRC) screening utilization over a 6-month observation period in African-American participants.
- To assess the intervention impact on CRC screening preference, classified into three levels (i.e., "decided not to screen or never heard of," "undecided," or "decided to screen"), based on data obtained from both the endpoint chart audit and the endpoint survey.
- To assess intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy related to CRC screening measured with 6 to 10 Likert-type items on both the baseline and endpoint surveys.
- To analyze intervention cost-effectiveness, from the societal perspective and from the more limited perspective of the provider and payer, focusing on the average and incremental cost per additional person who is compliant (i.e., has a CRC screening test during the observation period) for each alternative intervention and estimate the cost per life-year saved.
OUTLINE: This is a multicenter study. Participants are stratified according to practice. Participants are randomized to 1 of 2 intervention arms.
- Arm I (standard-intervention group): Participants receive a personalized screening invitation letter encouraging selection and performance of one of the screening tests, a generic colorectal cancer (CRC) screening informational booklet, stool blood testing (SBT) cards, and instructions for arranging a colonoscopy screening appointment. After 45 days, participants who have not been screened receive a reminder letter.
- Arm II (tailored-navigation intervention group): Participants receive a CRC screening invitation letter and materials that are tailored to the individual's preferred screening test strategy (i.e., SBT; SBT and instructions for arranging flexible sigmoidoscopy, instructions for arranging flexible sigmoidoscopy; or instructions for arranging colonoscopy). After 30 days, participants who have not been screened will receive a reminder by telephone. Those participants who have undergone screening will be congratulated for taking the time and preventative action, and be encouraged to continue future screenings. After 45 days, participants who have not been screened receive a reminder letter.
Participants are assessed by a baseline survey consisting of personal background, cognitive and psychological representations, social support and influence, intention, and decision stage related to screening SBT and colonoscopy preference. Data obtained from the endpoint survey assessing whether participants and their providers discussed CRC screening before the study and opinions about the intervention, and an endpoint chart audit to gather data on participant CRC screening exam dates and exam results (i.e., screening SBT, flexible sigmoidoscopy, colonoscopy, double-contrast barium enema [DCBE] x-ray) are assessed for group differences.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| informational intervention | Other | – |
| medical chart review | Other | – |
| screening questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| barium enema injection | Procedure or surgery | – |
| colon imaging study | Procedure or surgery | – |
| screening colonoscopy | Procedure or surgery | – |
| sigmoidoscopy | Procedure or surgery | – |
Primary outcome
Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period
2 secondary outcomes
Intervention impact on CRC screening preference, based on data obtained from both the endpoint chart audit and the endpoint survey
Intervention impact on population health-management representations related to CRC screening, as assessed by perceived salience and coherence and self-efficacy-related CRC screening measured with 6 to 10 Likert-type items on both the baseline and end ...
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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.
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, United States
Ronald Myers, PhD principal investigator
Jefferson Medical College of Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing informational intervention, medical chart review and screening questionnaire administration in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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?
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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention impact on colorectal cancer (CRC) screening utilization over the 6-month observation period. 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 18 Dec 2013.