Colorectal CancerDATESNCT01514786
Decision Aid to Technologically Enhance Shared Decision Making
A study testing Colorectal Web in people with Colorectal Cancer, run by University of Michigan at 14 sites in United States.
Trial summary
Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. 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?
- Colorectal Web
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2012to Apr 2015
- 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
- 50-75 years of age
- not current with colorectal cancer screening
- scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician
- able to read English
- current contact information
Who cannot join
- history of colon cancer or adenomatous polyps
- history of dementia or psychosis
- contraindication to CRCS
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Children's and Family Medical Clinic
Allen Park, Michigan, 48101
Downriver Internists
Allen Park, Michigan, 48101
University of Michigan Family Medicine at Domino's
Ann Arbor, Michigan, 48106
University of Michigan Briarwood Family Medicine
Ann Arbor, Michigan, 48108
Dua Family Practice
Canton, Michigan, 48187
George C. Hawrot, MD
Dearborn, Michigan, 48124
Andrew Thomas, MD
Detroit, Michigan, 48201
Morang Chester Clinic
Detroit, Michigan, 48224
Rice Lanzilote & Egan
Detroit, Michigan, 48227
David Williams, MD
Detroit, Michigan, 48235
IPC - Livonia Internal Medicine
Livonia, Michigan, 48152
Lonnie Joe Jr. MD
Southfield, Michigan, 48075
Mark W. Sawka, MD
Woodhaven, Michigan, 48183
University of Michigan Family Medicine at Corner Health Center
Ypsilanti, Michigan, 48197
About this study
Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.
Read the detailed description
This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.
- Conditions
- Colorectal Cancer
- Being tested
- Colorectal Web
- Keywords
- Colorectal Cancer, Screening, Prevention
- 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 WebBehavioural
The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. |
| Intervention with Colorectal Website | Active comparator | Intervention website includes an interactive component including preferences and risk assessment. Receives: Behavioral: Colorectal Web |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.
Measured: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2014
- Study completionApr 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masahito Jimbo, MD, University of Michigan
- Investigators
- Masahito Jimbo, MD, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514786
- Sponsor's protocol ID
- HUM00044733
- Acronym
- DATES
- Status last verified
- Sep 2017
- First submitted
- 17 Jan 2012
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data is still being analyzed and papers written
Publications
Jimbo M, Sen A, Plegue MA, Hawley S, Kelly-Blake K, Rapai M, Zhang M, Zhang Y, Xie X, Ruffin MT 4th. Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Am J Prev Med. 2019 Jul;57(1):77-86. doi: 10.1016/j.amepre.2019.03.004. Epub 2019 May 23.
PubMed 31128959Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT 4th. Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:381. doi: 10.1186/1745-6215-14-381.
PubMed 24216139
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid to Technologically Enhance Shared Decision Making
- ClinicalTrials.gov ID
- NCT01514786
- Acronym / sponsor ID
- DATES / HUM00044733
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Screening, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 15 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.
Detailed description
This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. |
| Intervention with Colorectal Website | Active comparator | Behavioral: Colorectal WebIntervention website includes an interactive component including preferences and risk assessment. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50-75 years of age
- not current with colorectal cancer screening
- scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician
- able to read English
- current contact information
Key exclusion criteria (3 listed)
- history of colon cancer or adenomatous polyps
- history of dementia or psychosis
- contraindication to CRCS
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 WebThe intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS | Behavioural | Intervention with Colorectal Website |
Primary outcome
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits
Time frame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.
Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31128959Jimbo M, Sen A, Plegue MA, Hawley S, Kelly-Blake K, Rapai M, Zhang M, Zhang Y, Xie X, Ruffin MT 4th. Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Am J Prev Med. 2019 Jul;57(1):77-86. doi: 10.1016/j.amepre.2019.03.004. Epub 2019 May 23.
- Derived from this study: PubMed 24216139Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT 4th. Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:381. doi: 10.1186/1745-6215-14-381.
- Individual participant dataSharing planned: Yes. Data is still being analyzed and papers written
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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.
Masahito Jimbo, MD, PhD, MPH principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal Web in people with Colorectal Cancer, run by University of Michigan at 14 sites 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 5 inclusion and 3 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 15 Sep 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?
Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits (time frame: 6 months following intervention a chart audit will be conducted to determine if CRCS was completed.). 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 NCT01514786, which also lists 2 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 15 Sep 2017.