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Shared Decision-Making for Colorectal Cancer Screening

NCT ID: NCT00251862

Last Updated: 2013-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer screening Shared decision-making Decision aid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Decision aid plus YourDiseaseRisk

Patients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider.

Group Type EXPERIMENTAL

Web-based decision aid plus personalized risk assessment

Intervention Type BEHAVIORAL

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.

Decision aid alone

Patient's viewed decision aid only prior to a visit with their primary care provider.

Group Type EXPERIMENTAL

Web-based decision aid alone

Intervention Type BEHAVIORAL

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.

III

Standard care

Group Type SHAM_COMPARATOR

Generic website

Intervention Type BEHAVIORAL

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

Interventions

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Web-based decision aid plus personalized risk assessment

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.

Intervention Type BEHAVIORAL

Web-based decision aid alone

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.

Intervention Type BEHAVIORAL

Generic website

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Decision aid, personalized risk assessment tool Decision aid Control condtion

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul C. Schroy III, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

South Boston Community Health Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18080203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19933718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21902773 (View on PubMed)

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.

Reference Type RESULT
PMID: 20484090 (View on PubMed)

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.

Reference Type RESULT
PMID: 23159252 (View on PubMed)

Other Identifiers

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5R01HS013912-05

Identifier Type: AHRQ

Identifier Source: org_study_id

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