Colorectal CancerPACTNCT00672828
Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans
A study testing Non-tailored CRC screening brochure and Interactive computer intervention in people with Colorectal Cancer, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 51 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Non-tailored CRC screening brochure and Interactive computer intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this study
Official title: Promoting Colon Cancer Screening Among African Americans
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Non-tailored CRC screening brochure, Interactive computer intervention
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-tailored CRC screening brochureBehavioural
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
Interactive computer interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interactive computer intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Measured: 6 and 15 months post-intervention
Secondary outcomes (4)
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.
Measured: 1 week post-intervention
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.
Measured: 1 week post-intervention
Self-reported CRC health beliefs
Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
Measured: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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.
Measured: Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Rawl, PhD, RN, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672828
- Sponsor's protocol ID
- IUSN-0604-01B
- Other IDs
- CDR0000584262, 5R01CA115983-05
- Acronym
- PACT
- Status last verified
- Aug 2013
- First submitted
- 3 May 2008
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33549682Christy 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.
PubMed 23498096
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Colon Cancer Screening Among African Americans
- ClinicalTrials.gov ID
- NCT00672828
- Acronym / sponsor ID
- PACT / IUSN-0604-01B
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-tailored CRC screening brochure | Active comparator | Behavioral: Non-tailored CRC screening brochureParticipants 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. |
| Interactive computer intervention | Experimental | Behavioral: Interactive computer interventionParticipants 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. |
Who may qualify
- Ages
- 51 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-tailored CRC screening brochurePatients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested. | Behavioural | Non-tailored CRC screening brochure |
| Interactive computer intervention | Behavioural | Interactive computer intervention |
Primary outcome
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Time frame: 6 and 15 months post-intervention
4 secondary outcomes
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Time frame: 1 week post-intervention
Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Time frame: 1 week post-intervention
Self-reported CRC health beliefs
Time frame: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
- Derived from this study: PubMed 33549682Rawl 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.
- Derived from this study: PubMed 23498096Christy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Rawl, PhD, RN principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-tailored CRC screening brochure and Interactive computer intervention in people with Colorectal Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.