Colorectal NeoplasiaNCT00161460
Colorectal Cancer Screening Intervention in UWPN Clinics
A study testing colorectal cancer screening intervention in people with Colorectal Neoplasia, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Neoplasia
- What is being tested?
- colorectal cancer screening intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years and over, enrolled for medical care in the UWPN clinics
Who cannot join
- Primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.
Read the detailed description
Colorectal cancer is the second leading cause of cancer death in the United States. Colorectal cancer screening is widely recommended, but generally under-utilized. Previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. Barriers to screening include patient and provider-related factors. An innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services.
In this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. This network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. In the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. This module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. The information provided by this module will be supplemented by the services of a cancer prevention specialist. This person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests.
Outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. If successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.
- Conditions
- Colorectal Neoplasia
- Being tested
- colorectal cancer screening intervention
- Keywords
- Colorectal cancer, Mass screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal cancer screening interventionBehavioural
Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Study nurse contacts subjects who enroll in the intervention to provide detailed education about screening tests, to assess their risk for colorectal cancer, and to facilitate screening. Receives: Behavioral: colorectal cancer screening intervention |
| 2 | No intervention | Patients who do not enroll receive usual care from their primary care providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening test utilization
Measured: 6 months
Secondary outcomes (2)
Knowledge about colorectal cancer screening tests
Measured: 2 months
Cancer worry score
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cynthia Ko, University of Washington
- Investigators
- Cynthia Ko, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161460
- Sponsor's protocol ID
- 26840-J
- Other IDs
- 1R21CA107157
- Status last verified
- May 2016
- First submitted
- 8 Sep 2005
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening Intervention in UWPN Clinics
- ClinicalTrials.gov ID
- NCT00161460
- Acronym / sponsor ID
- 26840-J
- Conditions
- Colorectal Neoplasia
- Keywords
- Colorectal cancer, Mass screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Sep 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.
The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.
Detailed description
Colorectal cancer is the second leading cause of cancer death in the United States. Colorectal cancer screening is widely recommended, but generally under-utilized. Previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. Barriers to screening include patient and provider-related factors. An innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services.
In this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. This network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. In the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. This module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. The information provided by this module will be supplemented by the services of a cancer prevention specialist. This person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests.
Outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. If successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: colorectal cancer screening interventionStudy nurse contacts subjects who enroll in the intervention to provide detailed education about screening tests, to assess their risk for colorectal cancer, and to facilitate screening. |
| 2 | No intervention | –Patients who do not enroll receive usual care from their primary care providers. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 50 years and over, enrolled for medical care in the UWPN clinics
Key exclusion criteria (1 listed)
- Primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures
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 interventionEnrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests | Behavioural | 1 |
Primary outcome
Colorectal cancer screening test utilization
Time frame: 6 months
2 secondary outcomes
Knowledge about colorectal cancer screening tests
Time frame: 2 months
Cancer worry score
Time frame: 2 months
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 13 May 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.
Cynthia Ko, MD principal investigator
University of Washington
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 intervention in people with Colorectal Neoplasia, run by University of Washington 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 1 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 13 May 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?
Colorectal cancer screening test utilization (time frame: 6 months). 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 13 May 2016.