Shared Decision-Making for Colorectal Cancer Screening

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00251862
First received: November 9, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Shared Decision-Making for Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • Patient adherence

Secondary Outcome Measures:
  • Patient satisfaction
  • Patient knowledge

Estimated Enrollment: 900
Study Start Date: January 2005
Estimated Study Completion Date: September 2005
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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 FOBT;
  • No major co-morbidities that preclude CRC screening by any method

Exclusion Criteria:

  • Prior CRC screening by any method other than fecal 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251862

Contacts
Contact: Julie Glick, BA, MPH 617-638-8348 julie.glick@bmc.org
Contact: Patricia Robinson, MEd 617- 414-7893 patricia.robinson@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Julie Glick, BA, MPH     617-638-8348     julie.glick@bmc.org    
South Boston Community Health Center Recruiting
Boston, Massachusetts, United States, 02127
Contact: Patricia Robinson, MEd     617-414-7893     patricia.robinson@bmc.org    
Sponsors and Collaborators
Investigators
Principal Investigator: Paul C. Schroy III, MD, MPH Boston Medical Center
  More Information

No publications provided by Agency for Healthcare Research and Quality (AHRQ)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00251862     History of Changes
Other Study ID Numbers: 5 R01 HS013912-03, 5 R01 HS013912-03
Study First Received: November 9, 2005
Last Updated: November 9, 2005
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Colorectal cancer screening
Shared decision-making
Decision aid

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013