Colorectal CancerCRC-RATNCT01803009
Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
A study testing Patient views NCI CRC RAT and View presentation regarding current chance of having an advanced adenoma in people with Colorectal Cancer, run by Indiana University at 1 site in United States.
Trial summary
Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Patient views NCI CRC RAT and View presentation regarding current chance of having an advanced adenoma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-75 years old
- No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year.
- Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.
Who cannot join
- Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
- Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
- Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
- Inability to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health
Indianapolis, Indiana, 46202
About this study
Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.
- Conditions
- Colorectal Cancer
- Being tested
- Patient views NCI CRC RAT, View presentation regarding current chance of having an advanced adenoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient views NCI CRC RATBehavioural
View presentation regarding current chance of having an advanced adenomaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| One arm | Experimental | View CRC RAT and view presentation regarding risk of advanced adenoma Receives: Behavioral: Patient views NCI CRC RAT; Behavioral: View presentation regarding current chance of having an advanced adenoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with NCI CRC RAT
19 Likert-scale questions regarding usability of and satisfaction with the questions asked by the website to assess individual risk and the information provided
Measured: 1 day
Perceived risk of developing CRC
Six Likert-scale questions regarding the subject's perceived risk of developing CRC in next 5 years, 10 years, and lifetime, and compared to others of same age and gender.
Measured: 1 day
Intent to be screened within six months
Three multiple-choice questions regarding intent to be screened in next six months in general or with colonoscopy or stool testing. (Answer options: Definitely, Probably, Probably not, and Definitely not)
Measured: 6 months
Stage of readiness to screen
Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions
Measured: 1 day
Preferred CRC screening test
Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.
Measured: 1 day
Secondary outcomes (1)
Uptake of CRC screening
Phone call follow up and check of medical record.
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionOct 2013
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.
- More trials run by Indiana UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Schwartz, Indiana University
- Investigators
- Peter H. Schwartz, MD, PhD, Principal investigator, IU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803009
- Sponsor's protocol ID
- 1210009869
- Acronym
- CRC-RAT
- Status last verified
- Apr 2014
- First submitted
- 15 Feb 2013
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
- ClinicalTrials.gov ID
- NCT01803009
- Acronym / sponsor ID
- CRC-RAT / 1210009869
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Mar 2013 (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.
Little is known about the impact of risk assessment tools on decision-making by patients and clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. In this study, we will measure patients' satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. In addition, we will assess the impact of adding information about their chance of having an advanced adenoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm | Experimental | Behavioral: Patient views NCI CRC RAT, Behavioral: View presentation regarding current chance of having an advanced adenomaView CRC RAT and view presentation regarding risk of advanced adenoma |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75 years old
- No colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year.
- Appointment with healthcare practitioner in upcoming month or within the past six months at one of five Indiana University Health primary care sites.
Key exclusion criteria (4 listed)
- Undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding.
- Enrolled in "Trial of a Computer-Based Presentation of Quantitative Information about Colorectal Cancer Screening"; Dr. Schwartz's study that recently completed enrollment.
- Diagnosis with any of the following conditions: Ulcerative colitis, Crohn disease, Familial adenomatous polyposis (FAP), Hereditary Nonpolyposis Colorectal Cancer (HNPCC), Personal history of colorectal cancer or adenomatous polyp
- Inability to speak and read English
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 |
|---|---|---|
| Patient views NCI CRC RAT | Behavioural | One arm |
| View presentation regarding current chance of having an advanced adenoma | Behavioural | One arm |
Primary outcome
Satisfaction with NCI CRC RAT
Time frame: 1 day
19 Likert-scale questions regarding usability of and satisfaction with the questions asked by the website to assess individual risk and the information provided
Perceived risk of developing CRC
Time frame: 1 day
Six Likert-scale questions regarding the subject's perceived risk of developing CRC in next 5 years, 10 years, and lifetime, and compared to others of same age and gender.
Intent to be screened within six months
Time frame: 6 months
Three multiple-choice questions regarding intent to be screened in next six months in general or with colonoscopy or stool testing. (Answer options: Definitely, Probably, Probably not, and Definitely not)
Stage of readiness to screen
Time frame: 1 day
Measure calculated from patient's answers on 5 multiple-choice or Likert-scale questions
Preferred CRC screening test
Time frame: 1 day
Answer on a single multiple choice question, offering options of colonoscopy, stool test, or other.
1 secondary outcome
Uptake of CRC screening
Time frame: 6 months after intervention
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 Apr 2014.
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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.
Peter H. Schwartz, MD, PhD principal investigator
IU 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 Patient views NCI CRC RAT and View presentation regarding current chance of having an advanced adenoma in people with Colorectal Cancer, run by Indiana 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?
The sponsor lists 3 inclusion and 4 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 Apr 2014. 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?
Satisfaction with NCI CRC RAT (time frame: 1 day). The study lists 5 primary outcomes in all. 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 Apr 2014.