Colorectal CancerNCT01596582
Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
A study testing Risk Assessment in people with Colorectal Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a reluctance among… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Risk Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking "average-risk" patients 50 to 75 years of age;
- Due for CRC screening based on current recommendations (i.e. no prior screening or > 1year since last fecal occult blood testing [FOBT], > 3 years since last stool DNA test, > 5 years since last flexible sigmoidoscopy, virtual colonoscopy or double-contrast barium enema [DCBE], or > 10 years since last colonoscopy);
- Under the direct care of a staff (attending) primary care provider or physician extender;
- Absence of major co-morbidities that preclude CRC screening.
Who cannot join
- High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives < 60 years of age, chronic inflammatory bowel disease);
- Presence of "alarm" gastrointestinal symptoms, including rectal bleeding, recent change in bowel habits, abdominal pain, unexplained weight loss and iron deficiency anemia;
- Comorbidities that preclude CRC screening by any method;
- Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening
Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a reluctance among providers to acquiesce to patient preferences for a particular screening strategy when its differs from their own. The overall objective of this study is to assess whether risk stratification for advanced colorectal neoplasia influences clinical decision-making related to screening test selection and adherence within a SDM framework. Eligible subjects will be randomized to either an experimental arm, in which they will be asked to complete a 6-item risk assessment questionnaire known as the "Advanced Colorectal Neoplasia Index [ACNI]" after reviewing a web-based decision aid, or a control arm, in which they will only review the decision aid. Both interventions will take place just before a prearranged office visit with their provider. The primary outcome will be screening test ordered; secondary outcomes will include test completion rates, concordance between test preference and test ordered,, patient satisfaction with decision-making process, screening intentions, 6-month test completion rates and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments.
Read the detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States. Screening by any of at least 6 different methods is a cost-effective yet underutilized strategy for reducing both CRC incidence and mortality. Because these methods differ with respect to risks and benefits and because existing evidence fails to identify a single best strategy, most authoritative groups advocate a shared decision-making (SDM) approach when selecting an appropriate screening strategy. SDM is a sequential, interactive process involving information exchange, values clarification, decision-making and mutual agreement. To facilitate this process, patient-oriented decision aids have been developed to enable patients to identify a preferred strategy based on personal values and empower them to participate in the decision-making process. Our recent studies to date find that although decision aids enable patients to make informed choices, providers are often unwilling to acquiesce to patient preferences when they differ from their own. Since accurate risk assessment is a critical component of effective clinical decision-making, the investigators postulate that risk stratification for the point prevalence of advanced colorectal neoplasia will enable providers to incorporate objective risk-based criteria in their decision-making when considering patient preferences for screening. To that end, the investigators have recently developed and validated the so-called "Advanced Colorectal Neoplasia Index [ACNI]" that stratifies patients into low versus intermediate/high risk categories based on available clinical data, including age, sex, race/ethnicity, smoking history, daily alcohol intake and use of non-steroidal anti-inflammatory drugs. The overall objective of this study is to determine whether risk stratification using the ACNI influences clinical decision-making related to screening test selection and adherence to screening within a SDM framework.
Hypothesis: Providers who incorporate risk estimates of ACN in their decision-making when recommending screening tests are more likely to consider patient preferences for options other than colonoscopy than providers lacking this information.
- Conditions
- Colorectal Cancer
- Being tested
- Risk Assessment
- Keywords
- Colorectal cancer screening, Shared decision-making, Patient preferences, Risk assessment, Advanced colorectal neoplasia
- Medical subject headings
- Colorectal Neoplasms, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk AssessmentBehavioural
Also called ACNI
Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid. The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%) versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age (50-59, 60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, 20+ years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never). The index represents a prototype version of the Advanced Colorectal Neoplasia Index (Am J Gastroenterol 2015;110:1062-71).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Subjects randomized to the control arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider. |
| Risk Assessment | Experimental | Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider. Receives: Behavioral: Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Between Patient Preference and Test Ordered
Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.
Measured: 3 months
Secondary outcomes (5)
Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients
Concordance between patient preference and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.
Measured: 3 months
Satisfaction With Decision-making Process (SDMP)
SDMP was assessed on the posttest using the validated 12-item Satisfaction with the Decision-Making Process scale. Individual items are assigned a point value ranging from 1 for ''strongly disagree'' (or ''poor'') to 5 for ''strongly agree'' (or ''excellent''). A cumulative score is then calculated based on the summed response scores for each item (maximum score = 60). Data was missing for 11 patients in the concordant group and 6 patients in the discordant group
Measured: One month
Screening Intentions
Screening intentions were assessed on the posttest. Patients were asked how sure they were that they would complete the screening test that got scheduled Scores ranged from 5 = ''completely'' to 1 = ''not at all sure.'' Data was missing for 11 patients in the concordant group and 6 patients in the discordant group.
Measured: 3 months
Screening Test Completion
Test completion rates were tracked using BMC's electronic medical record, which captures results for all endoscopic procedures, imaging studies, and stool blood tests.
Measured: 6 months
Provider Satisfaction
Provider satisfaction was assessed based on responses to a 3-item pretest administered prior to commencement of the study and the same 3-item posttest. The 3 items assessed to the extent to which providers felt that personalized risk assessment would be useful for: (1) selecting an appropriate screening test for their average risk patients [test selection]; (2) reduce time to decide on an appropriate screening modality [save time]; and (3) make them more receptive to patient preferences and possibly order a screening test other than colonoscopy [receptive to patient preferences]. Responses were assigned a point value ranging from 5= "strongly agree" and 1 = "strongly disagree".
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul C Schroy, MD, MPH, Boston Medical Center
- Investigators
- Paul C Schroy III, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596582
- Sponsor's protocol ID
- NCI-CA131197
- Status last verified
- Mar 2017
- First submitted
- 7 May 2012
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schroy PC 3rd, Emmons K, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvanaman S, Evans S, Chaisson C, Pignone M, Prout M, Davidson P, Heeren TC. The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. Med Decis Making. 2011 Jan-Feb;31(1):93-107. doi: 10.1177/0272989X10369007. Epub 2010 May 18.
PubMed 20484090Schroy PC 3rd, Mylvaganam S, Davidson P. Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. Health Expect. 2014 Feb;17(1):27-35. doi: 10.1111/j.1369-7625.2011.00730.x. Epub 2011 Sep 8.
PubMed 21902773Schroy PC 3rd, Caron SE, Sherman BJ, Heeren TC, Battaglia TA. Risk assessment and clinical decision making for colorectal cancer screening. Health Expect. 2015 Oct;18(5):1327-38. doi: 10.1111/hex.12110. Epub 2013 Jul 30.
PubMed 23905546Schroy PC 3rd, Wong JB, O'Brien MJ, Chen CA, Griffith JL. A Risk Prediction Index for Advanced Colorectal Neoplasia at Screening Colonoscopy. Am J Gastroenterol. 2015 Jul;110(7):1062-71. doi: 10.1038/ajg.2015.146. Epub 2015 May 26.
PubMed 26010311Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.
PubMed 26785715
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT01596582
- Acronym / sponsor ID
- NCI-CA131197
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, Shared decision-making, Patient preferences, Risk assessment, Advanced colorectal neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a reluctance among providers to acquiesce to patient preferences for a particular screening strategy when its differs from their own. The overall objective of this study is to assess whether risk stratification for advanced colorectal neoplasia influences clinical decision-making related to screening test selection and adherence within a SDM framework. Eligible subjects will be randomized to either an experimental arm, in which they will be asked to complete a 6-item risk assessment questionnaire known as the "Advanced Colorectal Neoplasia Index [ACNI]" after reviewing a web-based decision aid, or a control arm, in which they will only review the decision aid. Both interventions will take place just before a prearranged office visit with their provider. The primary outcome will be screening test ordered; secondary outcomes will include test completion rates, concordance between test preference and test ordered,, patient satisfaction with decision-making process, screening intentions, 6-month test completion rates and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments.
Detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States. Screening by any of at least 6 different methods is a cost-effective yet underutilized strategy for reducing both CRC incidence and mortality. Because these methods differ with respect to risks and benefits and because existing evidence fails to identify a single best strategy, most authoritative groups advocate a shared decision-making (SDM) approach when selecting an appropriate screening strategy. SDM is a sequential, interactive process involving information exchange, values clarification, decision-making and mutual agreement. To facilitate this process, patient-oriented decision aids have been developed to enable patients to identify a preferred strategy based on personal values and empower them to participate in the decision-making process. Our recent studies to date find that although decision aids enable patients to make informed choices, providers are often unwilling to acquiesce to patient preferences when they differ from their own. Since accurate risk assessment is a critical component of effective clinical decision-making, the investigators postulate that risk stratification for the point prevalence of advanced colorectal neoplasia will enable providers to incorporate objective risk-based criteria in their decision-making when considering patient preferences for screening. To that end, the investigators have recently developed and validated the so-called "Advanced Colorectal Neoplasia Index [ACNI]" that stratifies patients into low versus intermediate/high risk categories based on available clinical data, including age, sex, race/ethnicity, smoking history, daily alcohol intake and use of non-steroidal anti-inflammatory drugs. The overall objective of this study is to determine whether risk stratification using the ACNI influences clinical decision-making related to screening test selection and adherence to screening within a SDM framework.
Hypothesis: Providers who incorporate risk estimates of ACN in their decision-making when recommending screening tests are more likely to consider patient preferences for options other than colonoscopy than providers lacking this information.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Subjects randomized to the control arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider. |
| Risk Assessment | Experimental | Behavioral: Risk AssessmentSubjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking "average-risk" patients 50 to 75 years of age;
- Due for CRC screening based on current recommendations (i.e. no prior screening or > 1year since last fecal occult blood testing [FOBT], > 3 years since last stool DNA test, > 5 years since last flexible sigmoidoscopy, virtual colonoscopy or double-contrast barium enema [DCBE], or > 10 years since last colonoscopy);
- Under the direct care of a staff (attending) primary care provider or physician extender;
- Absence of major co-morbidities that preclude CRC screening.
Key exclusion criteria (4 listed)
- High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives < 60 years of age, chronic inflammatory bowel disease);
- Presence of "alarm" gastrointestinal symptoms, including rectal bleeding, recent change in bowel habits, abdominal pain, unexplained weight loss and iron deficiency anemia;
- Comorbidities that preclude CRC screening by any method;
- Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues).
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 |
|---|---|---|
| Risk AssessmentAlso: ACNIPatients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid. The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%) versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age (50-59, 60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, 20+ years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never). The index represents a prototype version of the Advanced Colorectal Neoplasia Index (Am J Gastroenterol 2015;110:1062-71). | Behavioural | Risk Assessment |
Primary outcome
Concordance Between Patient Preference and Test Ordered
Time frame: 3 months
Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.
5 secondary outcomes
Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients
Time frame: 3 months
Satisfaction With Decision-making Process (SDMP)
Time frame: One month
Screening Intentions
Time frame: 3 months
Screening Test Completion
Time frame: 6 months
Provider Satisfaction
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20484090Schroy PC 3rd, Emmons K, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvanaman S, Evans S, Chaisson C, Pignone M, Prout M, Davidson P, Heeren TC. The impact of a novel computer-based decision aid on shared decision making for colorectal cancer screening: a randomized trial. Med Decis Making. 2011 Jan-Feb;31(1):93-107. doi: 10.1177/0272989X10369007. Epub 2010 May 18.
- Background: PubMed 21902773Schroy PC 3rd, Mylvaganam S, Davidson P. Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making. Health Expect. 2014 Feb;17(1):27-35. doi: 10.1111/j.1369-7625.2011.00730.x. Epub 2011 Sep 8.
- Background: PubMed 23905546Schroy PC 3rd, Caron SE, Sherman BJ, Heeren TC, Battaglia TA. Risk assessment and clinical decision making for colorectal cancer screening. Health Expect. 2015 Oct;18(5):1327-38. doi: 10.1111/hex.12110. Epub 2013 Jul 30.
- Background: PubMed 26010311Schroy PC 3rd, Wong JB, O'Brien MJ, Chen CA, Griffith JL. A Risk Prediction Index for Advanced Colorectal Neoplasia at Screening Colonoscopy. Am J Gastroenterol. 2015 Jul;110(7):1062-71. doi: 10.1038/ajg.2015.146. Epub 2015 May 26.
- Results publication: PubMed 26785715Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.
- Individual participant dataSharing planned: No
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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.
Paul C Schroy III, MD, MPH principal investigator
Boston 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 Risk Assessment in people with Colorectal Cancer, run by Boston 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 4 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 21 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concordance Between Patient Preference and Test Ordered (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596582, which also lists 5 linked publications.
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 21 Mar 2017.