Colorectal Cancer ScreeningNCT00503737
Pilot Study of the National Colorectal Cancer Roundtable Toolbox (NCCRT) to Increase Colorectal Cancer Screening Rates
A study testing National Colorectal Cancer Roundtable Toolbox in people with Colorectal Cancer Screening, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The American Cancer Society and The Centers for Disease Control and Prevention in collaboration with The National Colorectal Cancer Roundtable published "How to Increase Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based Toolbox and Guide" in 2005. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- National Colorectal Cancer Roundtable Toolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to 1 Sep 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care providers who are currently practicing and recommending CRCS.
Who cannot join
- Any provider not at the clinics of interest
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The American Cancer Society and The Centers for Disease Control and Prevention in collaboration with The National Colorectal Cancer Roundtable published "How to Increase Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based Toolbox and Guide" in 2005. This toolbox outlines evidence-based interventions aimed at increasing colorectal cancer screening by primary care providers and their office staff. The Toolbox contains the tools to design a multifaceted intervention to increase primary care physician rates of colorectal cancer screening (CRCS). This is a pilot study to look at implementing the toolbox and its affects.
Read the detailed description
The specific aims of the intervention are: (1) To increase the knowledge of primary care providers as it pertains to current guidelines and communication strategies about colorectal cancer screening (CRCS); (2) To assist offices design a colorectal cancer screening policy, (3) To assist offices adopt a colorectal cancer reminder system and (4) To increase the screening rates of CRC screening. A secondary aim of this project is to synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox. Our hypothesis is that the practices that implement the toolbox will have a higher rate of colorectal cancer screening than the control group and physician knowledge about CRCS will be increased.
Two of the three sites will be randomly chosen by a number generator to be the intervention sites using the toolbox; the third will be used as a control site. Primary care providers will be defined as Family Practice physicians, General Internists, Nurse Practitioners, and Physician Assistants. Each site has on average of 5-12 providers.
Measurements of baseline rates of CRCS will be assessed by HIPAA compliant chart review for participating providers in the practice by our research coordinator. A list of qualifying patients will be generated by our billing department based on time seen, and billing code. These charts will then be randomly pulled and reviewed by our research coordinator to determine the percentage of eligible subjects who were screened for colorectal cancer (CRC) at each site. A total of 300 charts will be reviewed, broken down into 150 charts pre intervention and 150 charts post intervention. The post intervention chart review will be done at 1 year so that the patients can complete CRCS. The chart review will be done per site (i.e. no link between the individual providers and the patient will be made.) Also the sites will be de-identified so that there is no physician, or group of physicians who are held up to scrutiny.
CRC screening will be considered complete if one of the following was done: (1) Fecal occult blood test (FOBT) in the past year, (2) flexible sigmoidoscopy in the past 5 years, (3) FOBT in the past year and flexible sigmoidoscopy in the past five years (4) double contrast barium enema in the past five years, or (5) colonoscopy in the past 10 years. This will serve as a baseline-screening rate for each practice. Recordable data will be as follows: Sex, Race, Age, Site, Did provider recommend CRCS?, Did the subject follow through with recommendation?, If so, what was the chosen screening modality?, Does the subject have a family history of a 1st or 2nd degree relative with CRC?, Does the subject have a family history of a 1st or 2nd degree relative with adenomatous polyps? For the providers in the intervention group, they will be asked to attend a lunchtime lecture given by the PI on CRCS. They will also be asked to do a 20 question pre and post intervention questionnaire and a pre and post intervention health care provider survey. They will also be provided with brochures from the American Cancer Society. The providers in the control group will only complete the survey and the questionnaire.
- Conditions
- Colorectal Cancer Screening
- Being tested
- National Colorectal Cancer Roundtable Toolbox
- Keywords
- colorectal cancer screening, National Colorectal Cancer Roundtable Toolbox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National Colorectal Cancer Roundtable ToolboxBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Screening Toolkit | Active comparator | Toolbox includes tools and guides designed increase screening by primary care physicians Receives: Behavioral: National Colorectal Cancer Roundtable Toolbox |
| Standard of Care Colorectal Cancer Screening | No intervention | Primary Care physician will screen for colorectal cancer as per his/her standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the knowledge of providers as it pertains to current guidelines and strategies about CRCS; assist offices design a CRCS policy, assist offices adopt a CRC reminder system and increase the screening rates of CRC.
Measured: 2 years
Secondary outcomes (1)
synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox.
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 posted19 Jul 2007 (estimated)
- Study startSep 2007
- Primary completion1 Sep 2010
- Study completion1 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Downey, MD, Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503737
- Sponsor's protocol ID
- 25737
- Status last verified
- May 2018
- First submitted
- 17 Jul 2007
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the National Colorectal Cancer Roundtable Toolbox (NCCRT) to Increase Colorectal Cancer Screening Rates
- ClinicalTrials.gov ID
- NCT00503737
- Acronym / sponsor ID
- 25737
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal cancer screening, National Colorectal Cancer Roundtable Toolbox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- 1 Sep 2010 (actual)
- Study completion
- 1 Sep 2010 (actual)
- First posted
- 19 Jul 2007 (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 American Cancer Society and The Centers for Disease Control and Prevention in collaboration with The National Colorectal Cancer Roundtable published "How to Increase Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based Toolbox and Guide" in 2005. This toolbox outlines evidence-based interventions aimed at increasing colorectal cancer screening by primary care providers and their office staff. The Toolbox contains the tools to design a multifaceted intervention to increase primary care physician rates of colorectal cancer screening (CRCS). This is a pilot study to look at implementing the toolbox and its affects.
Detailed description
The specific aims of the intervention are: (1) To increase the knowledge of primary care providers as it pertains to current guidelines and communication strategies about colorectal cancer screening (CRCS); (2) To assist offices design a colorectal cancer screening policy, (3) To assist offices adopt a colorectal cancer reminder system and (4) To increase the screening rates of CRC screening. A secondary aim of this project is to synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox. Our hypothesis is that the practices that implement the toolbox will have a higher rate of colorectal cancer screening than the control group and physician knowledge about CRCS will be increased.
Two of the three sites will be randomly chosen by a number generator to be the intervention sites using the toolbox; the third will be used as a control site. Primary care providers will be defined as Family Practice physicians, General Internists, Nurse Practitioners, and Physician Assistants. Each site has on average of 5-12 providers.
Measurements of baseline rates of CRCS will be assessed by HIPAA compliant chart review for participating providers in the practice by our research coordinator. A list of qualifying patients will be generated by our billing department based on time seen, and billing code. These charts will then be randomly pulled and reviewed by our research coordinator to determine the percentage of eligible subjects who were screened for colorectal cancer (CRC) at each site. A total of 300 charts will be reviewed, broken down into 150 charts pre intervention and 150 charts post intervention. The post intervention chart review will be done at 1 year so that the patients can complete CRCS. The chart review will be done per site (i.e. no link between the individual providers and the patient will be made.) Also the sites will be de-identified so that there is no physician, or group of physicians who are held up to scrutiny.
CRC screening will be considered complete if one of the following was done: (1) Fecal occult blood test (FOBT) in the past year, (2) flexible sigmoidoscopy in the past 5 years, (3) FOBT in the past year and flexible sigmoidoscopy in the past five years (4) double contrast barium enema in the past five years, or (5) colonoscopy in the past 10 years. This will serve as a baseline-screening rate for each practice. Recordable data will be as follows: Sex, Race, Age, Site, Did provider recommend CRCS?, Did the subject follow through with recommendation?, If so, what was the chosen screening modality?, Does the subject have a family history of a 1st or 2nd degree relative with CRC?, Does the subject have a family history of a 1st or 2nd degree relative with adenomatous polyps? For the providers in the intervention group, they will be asked to attend a lunchtime lecture given by the PI on CRCS. They will also be asked to do a 20 question pre and post intervention questionnaire and a pre and post intervention health care provider survey. They will also be provided with brochures from the American Cancer Society. The providers in the control group will only complete the survey and the questionnaire.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Screening Toolkit | Active comparator | Behavioral: National Colorectal Cancer Roundtable ToolboxToolbox includes tools and guides designed increase screening by primary care physicians |
| Standard of Care Colorectal Cancer Screening | No intervention | –Primary Care physician will screen for colorectal cancer as per his/her standard practice |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health care providers who are currently practicing and recommending CRCS.
Key exclusion criteria (1 listed)
- Any provider not at the clinics of interest
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 |
|---|---|---|
| National Colorectal Cancer Roundtable Toolbox | Behavioural | Colorectal Cancer Screening Toolkit |
Primary outcome
Increase the knowledge of providers as it pertains to current guidelines and strategies about CRCS; assist offices design a CRCS policy, assist offices adopt a CRC reminder system and increase the screening rates of CRC.
Time frame: 2 years
1 secondary outcome
synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox.
Time frame: 2 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 29 May 2018.
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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.
Matthew J Downey, MD principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing National Colorectal Cancer Roundtable Toolbox in people with Colorectal Cancer Screening, run by Milton S. Hershey Medical Center 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 29 May 2018. 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?
Increase the knowledge of providers as it pertains to current guidelines and strategies about CRCS; assist offices design a CRCS policy, assist offices adopt a CRC reminder system and increase the screening rates of CRC. (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 29 May 2018.