Shared Decision-Making for Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00251862
First received: November 9, 2005
Last updated: December 2, 2013
Last verified: September 2013
  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: Web-based decision aid plus personalized risk assessment
Behavioral: Web-based decision aid alone
Behavioral: Generic website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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 (Test Completion) [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Completion of a screening test within 12 months of the study visit.


Secondary Outcome Measures:
  • Patient Knowledge [ Time Frame: Immediate post-intervention study visit ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction With Decision Making Process [ Time Frame: Immediate post-intervention primary care provider (PCP) visit ] [ Designated as safety issue: No ]
    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.

  • Screening Intentions [ Time Frame: Immediate post-intervention study visit ] [ Designated as safety issue: No ]
    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".


Enrollment: 825
Study Start Date: January 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.
Other Name: Decision aid, personalized risk assessment tool
Experimental: Decision aid alone
Patient's viewed decision aid only prior to a visit with their primary care provider.
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.
Other Name: Decision aid
Sham Comparator: III
Standard care
Behavioral: Generic website
Patients review a generic website that discuss ways to reduce overall cancer risk.
Other Name: Control condtion

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251862

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
South Boston Community Health Center
Boston, Massachusetts, United States, 02127
Sponsors and Collaborators
Investigators
Principal Investigator: Paul C. Schroy III, MD, MPH Boston Medical Center
  More Information

Publications:
Responsible Party: Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier: NCT00251862     History of Changes
Other Study ID Numbers: 5 R01 HS013912-05
Study First Received: November 9, 2005
Results First Received: July 23, 2013
Last Updated: December 2, 2013
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014