Colon CancerNCT01801059
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer
A study testing educational intervention and questionnaire administration in people with Colon Cancer and Rectal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- educational intervention and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is 50+ years of age
- Patient is in need of CRC screening
- Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
- Patient is not pregnant
- Patient is able to speak, read, and understand English
Who cannot join
- Patient is within CRC screening guidelines
- Patient is at high risk for CRC
- Patient cannot understand English
- Patient cannot complete a CRC screening test
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)
This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.
SECONDARY OBJECTIVES:
- To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.
II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.
OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.
ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.
ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.
After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- educational intervention, questionnaire administration
- Keywords
- colon cancer, Colorectal Cancer Screening
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Receive patient activation intervention by educational video and brochure
educational interventionOther
Also called intervention, educational
Receive patient activation intervention by educational video
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I education CRC and CRC screening | Active comparator | Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention. Receives: Other: educational intervention; Other: questionnaire administration |
| Arm II education and patient activation intervention | Experimental | Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention. Receives: Other: educational intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of CRC screening
A test of two proportions will be used. If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables. The variables that differ between the two groups will be tested as confounders using risk-factor modeling. Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startSep 2007
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mira Katz, Ohio State University Comprehensive Cancer Center
- Investigators
- Mira Katz, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801059
- Sponsor's protocol ID
- OSU-07104
- Other IDs
- NCI-2012-01922
- Status last verified
- Oct 2014
- First submitted
- 26 Feb 2013
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)
- ClinicalTrials.gov ID
- NCT01801059
- Acronym / sponsor ID
- OSU-07104
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- colon cancer, Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Feb 2013 (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.
This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.
SECONDARY OBJECTIVES:
- To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.
II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.
OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.
ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.
ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.
After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I education CRC and CRC screening | Active comparator | Other: educational intervention, Other: questionnaire administrationEducational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention. |
| Arm II education and patient activation intervention | Experimental | Other: educational intervention, Other: questionnaire administrationEducational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is 50+ years of age
- Patient is in need of CRC screening
- Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
- Patient is not pregnant
- Patient is able to speak, read, and understand English
Key exclusion criteria (4 listed)
- Patient is within CRC screening guidelines
- Patient is at high risk for CRC
- Patient cannot understand English
- Patient cannot complete a CRC screening test
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalReceive patient activation intervention by educational video and brochure | Other | Arm I education CRC and CRC screening, Arm II education and patient activation intervention |
| educational interventionAlso: intervention, educationalReceive patient activation intervention by educational video | Other | Arm I education CRC and CRC screening, Arm II education and patient activation intervention |
| questionnaire administrationAncillary studies | Other | Arm I education CRC and CRC screening, Arm II education and patient activation intervention |
Primary outcome
Completion rate of CRC screening
Time frame: Up to 2 months
A test of two proportions will be used. If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables. The variables that differ between the two groups will be tested as confounders using risk-factor modeling. Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.
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 16 Oct 2014.
- JameslineLink provided by the sponsor.
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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.
Mira Katz principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention and questionnaire administration in people with Colon Cancer and Rectal Cancer, run by Ohio State University Comprehensive Cancer Center 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?
The sponsor lists 5 inclusion and 4 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 16 Oct 2014. 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?
Completion rate of CRC screening (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2014.