Expired Study
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Indianapolis, Indiana 46202


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

IUSN-0604-01B


NCT ID:

NCT00672828


Secondary ID:

CDR0000584262


Study Acronym:

PACT


Brief Title:

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


Official Title:

Promoting Colon Cancer Screening Among African Americans


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

51 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

693


Enrollment Type:

Actual


Overall Contact Information

Official Name:Susan Rawl, PhD, RN
Principal Investigator
Indiana University School of Medicine

Study Dates

Start Date:January 2008
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:April 2012
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:August 16, 2013
First Received Date:May 3, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Self-reported stage of CRC screening test adoption
Time Frame:Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post
Safety Issues:False
Description:For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.
Outcome Type:Secondary Outcome
Measure:Self-reported CRC health beliefs
Time Frame:Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
Safety Issues:False
Description:Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
Outcome Type:Secondary Outcome
Measure:Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Time Frame:1 week post-intervention
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Time Frame:1 week post-intervention
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure:Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Time Frame:6 and 15 months post-intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Non-tailored CRC screening brochure
Description:Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
Arm Name:Non-tailored CRC screening brochure
Intervention Type:Behavioral
Name:Interactive computer intervention
Arm Name:Interactive computer intervention

Study Arms

Study Arm Type:Active Comparator
Arm Name:Non-tailored CRC screening brochure
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.
Study Arm Type:Experimental
Arm Name:Interactive computer intervention
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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