NCT00672828

Brief Summary

RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans. PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
693

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

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, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

4.3 years

First QC Date

May 3, 2008

Last Update Submit

August 16, 2013

Conditions

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion

    6 and 15 months post-intervention

Secondary Outcomes (4)

  • Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date

    1 week post-intervention

  • Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date

    1 week post-intervention

  • Self-reported CRC health beliefs

    Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention

  • Self-reported stage of CRC screening test adoption

    Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention

Other Outcomes (2)

  • Patient characteristics as CRC screening predictors

    Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention

  • Clinic variables as CRC screening predictors

    Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention

Study Arms (2)

Non-tailored CRC screening brochure

ACTIVE COMPARATOR

Participants undergo a baseline interview via telephone and receive a non-tailored CRC screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Behavioral: Non-tailored CRC screening brochure

Interactive computer intervention

EXPERIMENTAL

Participants undergo a baseline interview via telephone and complete an interactive computer intervention in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Behavioral: Interactive computer intervention

Interventions

Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.

Non-tailored CRC screening brochure
Interactive computer intervention

Eligibility Criteria

Age51 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Currently being seen in the primary care clinics of Wishard Memorial Hospital (Indianapolis, IN), Roudebush Veterans Affairs Medical Center (Indianapolis, IN), IU Health Family Medicine Center (Indianapolis, IN) or Norton Louisville Primary Care Clinic (Louisville, KY) * African-American who is currently non-adherent to screening guidelines, meeting all of the following criteria: * No fecal occult blood test in the past 12 months * No sigmoidoscopy in the past 5 years * No colonoscopy in the past 10 years * Patients with average and increased risk for colorectal cancer are eligible * No personal history of colorectal cancer PATIENT CHARACTERISTICS: * Participants must have a telephone * English-speaking * Able to read at a 5th grade reading level * No medical condition that prohibits colorectal cancer screening PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • Rawl SM, Christy SM, Perkins SM, Tong Y, Krier C, Wang HL, Huang AM, Laury E, Rhyant B, Lloyd F, Willis DR, Imperiale TF, Myers LJ, Springston J, Skinner CS, Champion VL. Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial. Prev Med. 2021 Apr;145:106449. doi: 10.1016/j.ypmed.2021.106449. Epub 2021 Feb 4.

  • Christy SM, Perkins SM, Tong Y, Krier C, Champion VL, Skinner CS, Springston JK, Imperiale TF, Rawl SM. Promoting colorectal cancer screening discussion: a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4):325-329. doi: 10.1016/j.amepre.2012.11.032.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan Rawl, PhD, RN

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2008

First Posted

May 6, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations