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Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans (PACT)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-tailored CRC screening brochure
Interactive computer intervention
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

51 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-tailored CRC screening brochure

Interactive computer intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Discussion of Fecal Occult Blood Test (FOBT), colonoscopy, and sigmoidoscopy is assessed. Participants report on whether or not an FOBT kit was given to them during this visit. Additionally, participants report on whether or not someone in the doctor's office made an appointment for a colonoscopy or sigmoidoscopy.
Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Medical record documentation of discussion of FOBT, providing participant with an FOBT kit, discussion and/or ordering a colonoscopy, and discussion and/or ordering a sigmoidoscopy is assessed.
Self-reported CRC health beliefs
Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
Self-reported stage of CRC screening test adoption
For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.

Full Information

First Posted
May 3, 2008
Last Updated
August 16, 2013
Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00672828
Brief Title
Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans
Acronym
PACT
Official Title
Promoting Colon Cancer Screening Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Compare rates of participation in fecal occult blood testing and endoscopic screening (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure. Examine mediators and moderators of intervention effectiveness as depicted in the conceptual model. OUTLINE: This is a multicenter study. Participants are stratified according to site, age (≤ 65 years old vs > 65 years old) and gender. Participants are randomized to one of two arms. Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a baseline interview via telephone and receive a colorectal cancer screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months. Arm II (interactive computer intervention [ICI]): Participants undergo a baseline interview via telephone and complete an ICI in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
693 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-tailored CRC screening brochure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Interactive computer intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-tailored CRC screening brochure
Intervention Description
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
Intervention Type
Behavioral
Intervention Name(s)
Interactive computer intervention
Primary Outcome Measure Information:
Title
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Time Frame
6 and 15 months post-intervention
Secondary Outcome Measure Information:
Title
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Description
Discussion of Fecal Occult Blood Test (FOBT), colonoscopy, and sigmoidoscopy is assessed. Participants report on whether or not an FOBT kit was given to them during this visit. Additionally, participants report on whether or not someone in the doctor's office made an appointment for a colonoscopy or sigmoidoscopy.
Time Frame
1 week post-intervention
Title
Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Description
Medical record documentation of discussion of FOBT, providing participant with an FOBT kit, discussion and/or ordering a colonoscopy, and discussion and/or ordering a sigmoidoscopy is assessed.
Time Frame
1 week post-intervention
Title
Self-reported CRC health beliefs
Description
Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
Time Frame
Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
Title
Self-reported stage of CRC screening test adoption
Description
For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.
Time Frame
Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
Other Pre-specified Outcome Measures:
Title
Patient characteristics as CRC screening predictors
Description
Age, gender, marital status, education, health literacy, income, employment, insurance coverage, BMI, co-morbidities, family history of cancer, family or friend encouragement to have CRC screening, CRC knowledge, physician trust, fatalism views, and health temporal orientation are assessed.
Time Frame
Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
Title
Clinic variables as CRC screening predictors
Description
Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.
Time Frame
Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Rawl, PhD, RN
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Nursing
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33549682
Citation
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.
Results Reference
derived
PubMed Identifier
23498096
Citation
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.
Results Reference
derived

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Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans

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