NCT00251862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 2, 2013

Completed
Last Updated

December 27, 2013

Status Verified

September 1, 2013

Enrollment Period

5.9 years

First QC Date

November 9, 2005

Results QC Date

July 23, 2013

Last Update Submit

December 2, 2013

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screeningShared decision-makingDecision aid

Outcome Measures

Primary Outcomes (1)

  • Patient Adherence (Test Completion)

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

    12 months post-intervention

Secondary Outcomes (3)

  • Patient Knowledge

    Immediate post-intervention study visit

  • Patient Satisfaction With Decision Making Process

    Immediate post-intervention primary care provider (PCP) visit

  • Screening Intentions

    Immediate post-intervention study visit

Study Arms (3)

Decision aid plus YourDiseaseRisk

EXPERIMENTAL

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

Decision aid alone

EXPERIMENTAL

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

Behavioral: Web-based decision aid alone

III

SHAM COMPARATOR

Standard care

Behavioral: Generic website

Interventions

Web-based decision aid plus personalized risk assessmentBEHAVIORAL

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.

Also known as: Decision aid, personalized risk assessment tool
Decision aid plus YourDiseaseRisk
Web-based decision aid aloneBEHAVIORAL

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.

Also known as: Decision aid
Decision aid alone
Generic websiteBEHAVIORAL

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

Also known as: Control condtion
III

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

South Boston Community Health Center

Boston, Massachusetts, 02127, United States

Location

Related Publications (5)

  • 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.

    PMID: 18080203BACKGROUND

  • 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.

    PMID: 19933718BACKGROUND

  • 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.

    PMID: 21902773BACKGROUND

  • 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.

    PMID: 20484090RESULT

  • 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.

    PMID: 23159252RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Paul C. Schroy III
Organization
Boston Medical Center
paul.schroy@bmc.org
617-638-8335

Study Officials

  • Paul C. Schroy III, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 27, 2013

Results First Posted

December 2, 2013

Record last verified: 2013-09

Locations

US(2)