AzTrials
AzTrials

Colorectal CancerNCT00251862

Shared Decision-Making for Colorectal Cancer Screening

A study testing Web-based decision aid plus personalized risk assessment, Web-based decision aid alone and Generic website in people with Colorectal Cancer, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations. 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?
Web-based decision aid plus personalized risk assessment, Web-based decision aid alone and Generic website
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
825 participants
Where
2 sitesUnited States
Study dates
Jan 2005to Dec 2010
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asymptomatic average-risk subjects
  • Under the direct care of one of participating site's staff (attending) physicians or physician extenders;
  • No prior screening other than fecal occult blood testing (FOBT);
  • No major co-morbidities that preclude CRC screening by any method

Who cannot join

  • Prior CRC screening by any method other than FOBT occult blood testing
  • High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives, chronic inflammatory bowel disease)
  • 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);
  • Comorbidities that preclude CRC screening by any method

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • South Boston Community Health Center

    Boston, Massachusetts, 02127

Other trials in United States

About this study

The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.

Read the detailed description

Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice.

Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).

Being tested
Web-based decision aid plus personalized risk assessment, Web-based decision aid alone, Generic website
Keywords
Colorectal cancer screening, Shared decision-making, Decision aid
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based decision aid plus personalized risk assessmentBehavioural

    Also called Decision aid, personalized risk assessment tool

    Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.

  • Web-based decision aid aloneBehavioural

    Also called Decision aid

    Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.

  • Generic websiteBehavioural

    Also called Control condtion

    Patients review a generic website that discuss ways to reduce overall cancer risk.

Study groups in NCT00251862
Study groupRoleWhat they receive
Decision aid plus YourDiseaseRiskExperimentalPatients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider.
Receives: Behavioral: Web-based decision aid plus personalized risk assessment
Decision aid aloneExperimentalPatient's viewed decision aid only prior to a visit with their primary care provider.
Receives: Behavioral: Web-based decision aid alone
IIISham comparatorStandard care
Receives: Behavioral: Generic website

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Adherence (Test Completion)

    Completion of a screening test within 12 months of the study visit.

    Measured: 12 months post-intervention

Secondary outcomes (3)

  1. Patient Knowledge

    Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.

    Measured: Immediate post-intervention study visit

  2. Patient Satisfaction With Decision Making Process

    Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for "strongly disagree" (or "poor") to 5 for "strongly agree" (or "excellent"). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.

    Measured: Immediate post-intervention primary care provider (PCP) visit

  3. Screening Intentions

    Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for "not at all sure" to 5 for "completely sure".

    Measured: Immediate post-intervention study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
Care provider
Enrolment
825 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251862
Sponsor's protocol ID
5R01HS013912-05
Status last verified
Sep 2013
First submitted
9 Nov 2005
Last updated
27 Dec 2013
Data monitoring committee
No

Publications

  • Schroy PC 3rd, Glick JT, Robinson PA, Lydotes MA, Evans SR, Emmons KM. Has the surge in media attention increased public awareness about colorectal cancer and screening? J Community Health. 2008 Feb;33(1):1-9. doi: 10.1007/s10900-007-9065-5.

    PubMed 18080203

  • Schroy PC 3rd, Glick JT, Robinson P, Lydotes MA, Heeren TC, Prout M, Davidson P, Wong JB. A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial. Clin Trials. 2009 Dec;6(6):597-609. doi: 10.1177/1740774509346703. Epub 2009 Nov 23.

    PubMed 19933718

  • Schroy 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 21902773

  • 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 20484090

  • Schroy PC 3rd, Emmons KM, Peters E, Glick JT, Robinson PA, Lydotes MA, Mylvaganam SR, Coe AM, Chen CA, Chaisson CE, Pignone MP, Prout MN, Davidson PK, Heeren TC. Aid-assisted decision making and colorectal cancer screening: a randomized controlled trial. Am J Prev Med. 2012 Dec;43(6):573-83. doi: 10.1016/j.amepre.2012.08.018.

    PubMed 23159252

Questions about this trial

What is this clinical trial studying?

A study testing Web-based decision aid plus personalized risk assessment, Web-based decision aid alone and Generic website in people with Colorectal Cancer, run by Agency for Healthcare Research and Quality (AHRQ) at 2 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 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. Some participants in this study may receive a placebo. 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 2 Dec 2013). 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?

Patient Adherence (Test Completion) (time frame: 12 months post-intervention). 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 NCT00251862, 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 27 Dec 2013.

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