Colon CancerNCT01526239
Reminding Patients of the Important of Colorectal Cancer Screening Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
A study testing Colorectal cancer screening pamphlet in people with Colon Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Colorectal cancer screening pamphlet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patient age older than 50, exception for African American age 45 and older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
OUHSC HSC, GI department
Oklahoma City, Oklahoma, 73104
About this study
Official title: Patient-Reminder Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
Colorectal cancer is the third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened.
Specific Aims
Read more
The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research:
- To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy.
- To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations.
- To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics.
At the close of the investigators study, the investigators wish to organize quantifiable data demonstrating how patient-initiated prompting of primary care physicians for CRC screening increases early detection and decreases potential mortality from colorectal cancer. This data will inform a second, larger study to pursue the questions surrounding patient-initiated prompting in
- Conditions
- Colon Cancer
- Being tested
- Colorectal cancer screening pamphlet
- Keywords
- Colorectal cancer screening, colon cancer screening, colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal cancer screening pamphletOther
Colorectal cancer screening pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention consisted of a pamphlet about the benefit of CRC-S, given to patients prior to their PCP visit and a reminder note about CRC screening to be given to their physician during the encounter. Receives: Other: Colorectal cancer screening pamphlet |
| Control group | No intervention | Control group will not receive the pamphlet regarding colorectal cancers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication with primary care physicians about CRC screening
The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526239
- Sponsor's protocol ID
- 14225
- Status last verified
- Jan 2012
- First submitted
- 3 Jan 2012
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reminder Results in Patient-Initiated Promoting Colorectal Cancer Screening Via Colonoscopy
- ClinicalTrials.gov ID
- NCT01526239
- Acronym / sponsor ID
- 14225
- Conditions
- Colon Cancer
- Keywords
- Colorectal cancer screening, colon cancer screening, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Feb 2012 (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 third most common cancer diagnosed and third leading cause of cancer-related deaths in the United States for both men and women. The American Cancer Society (ACS) estimates about 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer will be diagnosed, and about 49,960 deaths will occur as a result of this devastating disease in 2008. Over the last 20 years, the death rate for this cancer has been dropping as a result of screening and early detection of cancer. In 2007, ACS reported that early-stage colorectal cancer had a survival rate close to 80%, and up to 9,632 deaths could be prevented each year if eligible patients received screening when necessary. However, despite the proven efficacy of colorectal cancer (CRC) screening, only about 50% of eligible US patients are currently being screened.
Specific Aims
The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening. The following three areas will be investigated during this research:
- To determine whether a communication tool provided to patients will initiate a conversation with their primary care physicians about CRC screening, especially via colonoscopy.
- To determine whether this tool will impact referral patterns for screening, especially, although not primarily, among poor and underserved populations.
- To determine whether differences exist in regard to patient-physician communication patterns about screening among residents and faculties in the fields of internal medicine and family practice clinics.
At the close of the investigators study, the investigators wish to organize quantifiable data demonstrating how patient-initiated prompting of primary care physicians for CRC screening increases early detection and decreases potential mortality from colorectal cancer. This data will inform a second, larger study to pursue the questions surrounding patient-initiated prompting in
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Colorectal cancer screening pamphletIntervention consisted of a pamphlet about the benefit of CRC-S, given to patients prior to their PCP visit and a reminder note about CRC screening to be given to their physician during the encounter. |
| Control group | No intervention | –Control group will not receive the pamphlet regarding colorectal cancers. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient age older than 50, exception for African American age 45 and older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Colorectal cancer screening pamphletColorectal cancer screening pamphlet | Other | Intervention group |
Primary outcome
Communication with primary care physicians about CRC screening
Time frame: 2 years
The central hypothesis of this proposal is that patient-initiated prompting of primary care physicians of the patient's interest in screening will increase referrals for CRC screening.
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 3 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal cancer screening pamphlet in people with Colon Cancer, run by University of Oklahoma 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 1 inclusion and 0 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 3 Feb 2012. 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?
Communication with primary care physicians about CRC screening (time frame: 2 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 3 Feb 2012.