Colorectal NeoplasmsNCT00786747
Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
A study testing Personally tailored computer program in people with Colorectal Neoplasms, run by University of California, Davis at 5 sites in United States.
Trial summary
The study investigators have developed an interactive multimedia computer program that provides personally tailored education about colorectal cancer screening in the user's preferred language (English or Spanish). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Personally tailored computer program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,164 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2010to Nov 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receive primary care at one of the participating outpatient study offices
- Age at or above 50 years
- Able to read and speak English and/or Spanish
- Adequate vision, hearing, and hand function to use an IMCP running on a laptop computer via a touch screen interface
- Have an active telephone
- Not up to date for CRC screening. Up to date status will be defined as having completed CRC screening via: fecal occult blood test within 2 years; flexible sigmoidoscopy within 5 years; or colonoscopy within 10 years, consistent with national practice guidelines and standards.
Who cannot join
- Unable to understand the consent form or the telephone screening questionnaire due to cognitive impairment
- Unable to provide informed consent due to serious acute illness
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
Sophie Davis School of Biomedical Education, City University of New York,
New York, New York, 10031
University of Rochester School of Medicine and Dentistry
Rochester, New York, 14642
University of California, Davis Health System
Sacramento, California, 95817
University of Texas Health Sciences Center
San Antonio, Texas, 78229
About this study
The study investigators have developed an interactive multimedia computer program that provides personally tailored education about colorectal cancer screening in the user's preferred language (English or Spanish). In this study, the investigators will examine whether use of the computer program increases the number of Hispanic patients who receive colorectal cancer screening and lessens or eliminates the glaring disparity in screening between Hispanics and non-Hispanic whites.
Read the detailed description
- Background: Interactive multimedia computer programs (IMCPs) show promise as a way of delivering personally tailored (PT) information to enhance cognitive mediators of health behavior and improve patient outcomes. However, it is unclear whether PT IMCPs can be deployed in primary care offices to increase cancer screening uptake and eliminate ethnic disparities in uptake by providing PT information in each user's preferred language.
- Aims/Hypotheses: We will compare changes in colorectal cancer (CRC) screening cognitive mediators (self-efficacy, perceived barriers, and readiness) and uptake resulting from an IMCP - PT to enhance the key cognitive mediators and targeted to patients' self-identified ethnicity - with changes resulting from a non-tailored "electronic leaflet" control IMCP. The experimental and control IMCPs will each be offered in English and Spanish versions. We hypothesize that, compared with the appropriate control condition (English, Spanish, or both combined): (1) the English version of the PT IMCP will enhance the cognitive mediators of CRC screening behavior for English-speaking Hispanics and non-Hispanics; (2) there will be similarly favorable changes in these mediators for Hispanics using the Spanish version of the PT IMCP; (3) deployment of the PT IMCP will provide evidence of elimination of disparities in CRC screening between Hispanic and non-Hispanic subjects via its relative impact on the cognitive mediators in these groups; and (4) the PT IMCP (English and Spanish combined) will increase CRC screening uptake in Hispanics and non-Hispanics (considered separately) via changes in the cognitive mediators.
- Methods: Randomized controlled trial of 2 groups, comparing a PT (to the cognitive mediators) CRC screening IMCP offered in both English and Spanish versions and deployed before a primary care office visit with a non-tailored "electronic leaflet" CRC screening IMCP (control) also offered in both English and Spanish. Screening methods targeted will be fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. Primary outcomes will be CRC screening uptake, self-efficacy, perceived barriers, and readiness.
- Implications: Our findings will determine whether an IMCP that is PT to cognitive mediators of screening behavior and deployed in primary care offices prior to previously scheduled visits can activate patients of various ethnicities to undergo CRC screening. They may also suggest a promising, portable method of reducing disparities in CRC (and other) screening uptake between Hispanic and non-Hispanic individuals.
- Conditions
- Colorectal Neoplasms
- Being tested
- Personally tailored computer program, Non-tailored control computer program
- Keywords
- Computer-assisted instruction, Health knowledge, attitudes, practice, Mass screening, Patient acceptance of health care, Patient education as topic, Primary health care, Self-efficacy
- Medical subject headings
- Colorectal Neoplasms, Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personally tailored computer programBehavioural
The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish).
Non-tailored control computer programBehavioural
This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).
| Study group | Role | What they receive |
|---|---|---|
| Personally tailored computer program | Experimental | The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish). Receives: Behavioral: Personally tailored computer program |
| Non-tailored control computer program | Active comparator | This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish). Receives: Behavioral: Non-tailored control computer program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up to date colorectal cancer screening status
Measured: 1 year
Secondary outcomes (5)
Up to date colonoscopy screening status
Measured: 1 year
Up to date fecal occult blood testing status
Measured: 1 year
Colorectal cancer screening self-efficacy
Measured: Immediately after computer program use
Perceived barriers to colorectal cancer screening
Measured: Immediately after computer program use
Readiness to undergo colorectal cancer screening
Measured: Immediately after computer program use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, City University of New York, School of Public Health
- Responsible party
- Principal investigator, Anthony F. Jerant, University of California, Davis
- Investigators
- Anthony Jerant, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786747
- Sponsor's protocol ID
- NCI -1R01CA131386-01A1
- Other IDs
- ARRA CA13138602S1
- Status last verified
- Dec 2015
- First submitted
- 5 Nov 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sohler NL, Jerant A, Franks P. Socio-psychological factors in the Expanded Health Belief Model and subsequent colorectal cancer screening. Patient Educ Couns. 2015 Jul;98(7):901-7. doi: 10.1016/j.pec.2015.03.023. Epub 2015 Apr 8.
PubMed 25892503Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011 Nov;85(2):323-30. doi: 10.1016/j.pec.2010.11.012. Epub 2010 Dec 13.
PubMed 21146950Jerant A, Kravitz RL, Sohler N, Fiscella K, Romero RL, Parnes B, Tancredi DJ, Aguilar-Gaxiola S, Slee C, Dvorak S, Turner C, Hudnut A, Prieto F, Franks P. Sociopsychological tailoring to address colorectal cancer screening disparities: a randomized controlled trial. Ann Fam Med. 2014 May-Jun;12(3):204-14. doi: 10.1370/afm.1623.
PubMed 24821891Jerant A, Kravitz RL, Fiscella K, Sohler N, Romero RL, Parnes B, Aguilar-Gaxiola S, Turner C, Dvorak S, Franks P. Effects of tailored knowledge enhancement on colorectal cancer screening preference across ethnic and language groups. Patient Educ Couns. 2013 Jan;90(1):103-10. doi: 10.1016/j.pec.2012.08.017. Epub 2012 Sep 15.
PubMed 22985627Jerant A, To P, Franks P. The effects of tailoring knowledge acquisition on colorectal cancer screening self-efficacy. J Health Commun. 2015;20(6):697-709. doi: 10.1080/10810730.2015.1018562. Epub 2015 Apr 30.
PubMed 25928315
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
- ClinicalTrials.gov ID
- NCT00786747
- Acronym / sponsor ID
- NCI -1R01CA131386-01A1
- Conditions
- Colorectal Neoplasms
- Keywords
- Computer-assisted instruction, Health knowledge, attitudes, practice, Mass screening, Patient acceptance of health care, Patient education as topic, Primary health care, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Rochester, City University of New York, School of Public Health
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Nov 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.
The study investigators have developed an interactive multimedia computer program that provides personally tailored education about colorectal cancer screening in the user's preferred language (English or Spanish). In this study, the investigators will examine whether use of the computer program increases the number of Hispanic patients who receive colorectal cancer screening and lessens or eliminates the glaring disparity in screening between Hispanics and non-Hispanic whites.
Detailed description
- Background: Interactive multimedia computer programs (IMCPs) show promise as a way of delivering personally tailored (PT) information to enhance cognitive mediators of health behavior and improve patient outcomes. However, it is unclear whether PT IMCPs can be deployed in primary care offices to increase cancer screening uptake and eliminate ethnic disparities in uptake by providing PT information in each user's preferred language.
- Aims/Hypotheses: We will compare changes in colorectal cancer (CRC) screening cognitive mediators (self-efficacy, perceived barriers, and readiness) and uptake resulting from an IMCP - PT to enhance the key cognitive mediators and targeted to patients' self-identified ethnicity - with changes resulting from a non-tailored "electronic leaflet" control IMCP. The experimental and control IMCPs will each be offered in English and Spanish versions. We hypothesize that, compared with the appropriate control condition (English, Spanish, or both combined): (1) the English version of the PT IMCP will enhance the cognitive mediators of CRC screening behavior for English-speaking Hispanics and non-Hispanics; (2) there will be similarly favorable changes in these mediators for Hispanics using the Spanish version of the PT IMCP; (3) deployment of the PT IMCP will provide evidence of elimination of disparities in CRC screening between Hispanic and non-Hispanic subjects via its relative impact on the cognitive mediators in these groups; and (4) the PT IMCP (English and Spanish combined) will increase CRC screening uptake in Hispanics and non-Hispanics (considered separately) via changes in the cognitive mediators.
- Methods: Randomized controlled trial of 2 groups, comparing a PT (to the cognitive mediators) CRC screening IMCP offered in both English and Spanish versions and deployed before a primary care office visit with a non-tailored "electronic leaflet" CRC screening IMCP (control) also offered in both English and Spanish. Screening methods targeted will be fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. Primary outcomes will be CRC screening uptake, self-efficacy, perceived barriers, and readiness.
- Implications: Our findings will determine whether an IMCP that is PT to cognitive mediators of screening behavior and deployed in primary care offices prior to previously scheduled visits can activate patients of various ethnicities to undergo CRC screening. They may also suggest a promising, portable method of reducing disparities in CRC (and other) screening uptake between Hispanic and non-Hispanic individuals.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personally tailored computer program | Experimental | Behavioral: Personally tailored computer programThe experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish). |
| Non-tailored control computer program | Active comparator | Behavioral: Non-tailored control computer programThis program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Receive primary care at one of the participating outpatient study offices
- Age at or above 50 years
- Able to read and speak English and/or Spanish
- Adequate vision, hearing, and hand function to use an IMCP running on a laptop computer via a touch screen interface
- Have an active telephone
Key exclusion criteria (2 listed)
- Unable to understand the consent form or the telephone screening questionnaire due to cognitive impairment
- Unable to provide informed consent due to serious acute illness
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 |
|---|---|---|
| Personally tailored computer programThe experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish). | Behavioural | Personally tailored computer program |
| Non-tailored control computer programThis program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish). | Behavioural | Non-tailored control computer program |
Primary outcome
Up to date colorectal cancer screening status
Time frame: 1 year
5 secondary outcomes
Up to date colonoscopy screening status
Time frame: 1 year
Up to date fecal occult blood testing status
Time frame: 1 year
Colorectal cancer screening self-efficacy
Time frame: Immediately after computer program use
Perceived barriers to colorectal cancer screening
Time frame: Immediately after computer program use
Readiness to undergo colorectal cancer screening
Time frame: Immediately after computer program use
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 3 Dec 2015.
- Background: PubMed 25892503Sohler NL, Jerant A, Franks P. Socio-psychological factors in the Expanded Health Belief Model and subsequent colorectal cancer screening. Patient Educ Couns. 2015 Jul;98(7):901-7. doi: 10.1016/j.pec.2015.03.023. Epub 2015 Apr 8.
- Background: PubMed 21146950Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011 Nov;85(2):323-30. doi: 10.1016/j.pec.2010.11.012. Epub 2010 Dec 13.
- Results publication: PubMed 24821891Jerant A, Kravitz RL, Sohler N, Fiscella K, Romero RL, Parnes B, Tancredi DJ, Aguilar-Gaxiola S, Slee C, Dvorak S, Turner C, Hudnut A, Prieto F, Franks P. Sociopsychological tailoring to address colorectal cancer screening disparities: a randomized controlled trial. Ann Fam Med. 2014 May-Jun;12(3):204-14. doi: 10.1370/afm.1623.
- Results publication: PubMed 22985627Jerant A, Kravitz RL, Fiscella K, Sohler N, Romero RL, Parnes B, Aguilar-Gaxiola S, Turner C, Dvorak S, Franks P. Effects of tailored knowledge enhancement on colorectal cancer screening preference across ethnic and language groups. Patient Educ Couns. 2013 Jan;90(1):103-10. doi: 10.1016/j.pec.2012.08.017. Epub 2012 Sep 15.
- Results publication: PubMed 25928315Jerant A, To P, Franks P. The effects of tailoring knowledge acquisition on colorectal cancer screening self-efficacy. J Health Commun. 2015;20(6):697-709. doi: 10.1080/10810730.2015.1018562. Epub 2015 Apr 30.
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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.
Anthony Jerant, MD principal investigator
University of California, Davis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personally tailored computer program in people with Colorectal Neoplasms, run by University of California, Davis at 5 sites 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?
The sponsor lists 6 inclusion and 2 exclusion criteria. 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Up to date colorectal cancer screening status (time frame: 1 year). 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 NCT00786747, which also lists 5 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 3 Dec 2015.