Colorectal Cancer ScreeningCRCS-WISDMNCT01519999
Colorectal Cancer Screening With Improved Shared Decision Making
A study testing Shared Decision Making for Colorectal Cancer Screening in people with Colorectal Cancer Screening and Shared Decision Making, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. 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 Screening, Shared Decision Making
- What is being tested?
- Shared Decision Making for Colorectal Cancer Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206,721 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 18 Jul 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 to 75 years of age
- Lives in or receives care in the selected intervention or comparison (control) communities
- Average-risk for colorectal cancer
- Non-adherent to CRCS recommendation
- English-speaking
- People who consent to participate
Who cannot join
- <50 years of age or >75 years of age
- Not living in or receiving care in the selected intervention or comparison communities
- High-risk for colorectal cancer
- Adherent to CRCS recommendation
- Non-English speaking
- People who do not consent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Allina Health Systems - Commons
Minneapolis, Minnesota, 55404
About this study
Official title: Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)
The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).
Read the detailed description
Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N~50,000 patients.
Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).
- Being tested
- Shared Decision Making for Colorectal Cancer Screening
- Keywords
- Shared decision making, Ambulatory Care, Patient-Centered Care, Community-wide intervention, Intervention Study, Longitudinal Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making for Colorectal Cancer ScreeningBehavioural
Also called CRCS-WISDM
Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making | Experimental | Not described Receives: Behavioral: Shared Decision Making for Colorectal Cancer Screening |
| Comparison (control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colorectal cancer screening adherence
Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.
Measured: Baseline up to 24 months post intervention initiation
Secondary outcomes (5)
Decisional conflict
A previously validated decisional conflict scale, will be used, which includes 16 items all measured on a 5-point Likert-type scale. (e.g. difficulty in decision making, certainty with a decision, demonstrated feeling of understanding about risks and benefits of a decision, and satisfaction with a decision). Responses will be coded so that higher responses represent greater decisional conflict.
Measured: Baseline up to 24 months post intervention initiation
Modality-specific colorectal cancer screening barriers
A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement.
Measured: Baseline up to 24 months post intervention initiation
Colorectal cancer screening-related confusion
Colorectal cancer-related confusion will be measured using 9 items which will be coded on a scale from 1 to 5 where 5 represents greater confusion endorsement.
Measured: Baseline up to 24 months post intervention initiation
Patients' shared decision-making experience
Patients will answer multiple questions relating to their experience with the implementation of shared decision-making and their interactions with clinical staff. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.
Measured: Baseline up to 12 months post intervention initiation
Providers'/staff shared decision-making experience
Providers and staff will answer multiple questions relating to their experience with the implementation of shared decision-making with their patients in clinical practice. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.
Measured: Baseline up to 24 months post intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMay 2012
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 206,721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System, Blue Cross Blue Shield
- Responsible party
- Sponsor
- Investigators
- Resa M Jones, MPH, PhD, Principal investigator, Virginia Commonwealth University and Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519999
- Sponsor's protocol ID
- HM14436
- Other IDs
- WISDM-106965
- Acronym
- CRCS-WISDM
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2012
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)
- ClinicalTrials.gov ID
- NCT01519999
- Acronym / sponsor ID
- CRCS-WISDM / HM14436
- Keywords
- Shared decision making, Ambulatory Care, Patient-Centered Care, Community-wide intervention, Intervention Study, Longitudinal Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206,721 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Allina Health System, Blue Cross Blue Shield
- Study start
- May 2012
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 27 Jan 2012 (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 increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).
Detailed description
Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N~50,000 patients.
Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making | Experimental | Behavioral: Shared Decision Making for Colorectal Cancer Screening |
| Comparison (control) | No intervention | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 to 75 years of age
- Lives in or receives care in the selected intervention or comparison (control) communities
- Average-risk for colorectal cancer
- Non-adherent to CRCS recommendation
- English-speaking
Key exclusion criteria (6 listed)
- <50 years of age or >75 years of age
- Not living in or receiving care in the selected intervention or comparison communities
- High-risk for colorectal cancer
- Adherent to CRCS recommendation
- Non-English speaking
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 |
|---|---|---|
| Shared Decision Making for Colorectal Cancer ScreeningAlso: CRCS-WISDMAge-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities. | Behavioural | Shared Decision Making |
Primary outcome
Change in colorectal cancer screening adherence
Time frame: Baseline up to 24 months post intervention initiation
Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.
5 secondary outcomes
Decisional conflict
Time frame: Baseline up to 24 months post intervention initiation
Modality-specific colorectal cancer screening barriers
Time frame: Baseline up to 24 months post intervention initiation
Colorectal cancer screening-related confusion
Time frame: Baseline up to 24 months post intervention initiation
Patients' shared decision-making experience
Time frame: Baseline up to 12 months post intervention initiation
Providers'/staff shared decision-making experience
Time frame: Baseline up to 24 months post intervention initiation
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 4 Feb 2019.
Related trials for Colorectal Cancer Screening
Recruiting
Animated Storytelling to Promote Colorectal Cancer Screening
Colorectal Cancer Screening
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruiting
Guardant Shield Colorectal Cancer Screening
Colorectal Cancer
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.
Resa M Jones, MPH, PhD principal investigator
Virginia Commonwealth University and Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making for Colorectal Cancer Screening in people with Colorectal Cancer Screening and Shared Decision Making, run by Virginia Commonwealth 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 6 inclusion and 6 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 4 Feb 2019. 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?
Change in colorectal cancer screening adherence (time frame: Baseline up to 24 months post intervention initiation). 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 4 Feb 2019.