Clinical trial NCT00251862: Shared Decision-Making for Colorectal Cancer Screening
Official title: Shared Decision-Making for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer screening
Shared decision-making
Decision aid
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-11-11
Enrollment: 825
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Adherence (Test Completion)
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Patient Knowledge
timeFrame: Immediate post-intervention study visit
measure: Patient Satisfaction With Decision Making Process
timeFrame: Immediate post-intervention primary care provider (PCP) visit
measure: Screening Intentions
timeFrame: Immediate post-intervention study visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: South Boston Community Health Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Paul C. Schroy III, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.