Colorectal CancerNCT00924690
Colon Cancer Prevention Study
A study testing Behavioral Messages and Generic Messages in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this research study is to design messages which can help people learn more about how to prevent colon cancer. Eligible participants will be asked to review a series of short cancer prevention messages and share their opinions on them. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Behavioral Messages and Generic Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2009
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Ages 50-80 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Disparities in Colorectal Cancer Prevention Behaviors
The goal of this research study is to design messages which can help people learn more about how to prevent colon cancer. Eligible participants will be asked to review a series of short cancer prevention messages and share their opinions on them. Participants also need to fill out a short survey with questions on their background and attitudes and knowledge about physical activity and colon cancer. The whole study can be completed online and will take less than 1 hour. After completing the entire study, participants will receive $25.
If you are interested in participating in this study, please visit the following website:
https://surveys.chaicore.com/preventcancer/
Read the detailed description
The goal of this research is to develop and test potential intervention messages which can be used to help increase colon cancer prevention behaviors. Two sets of intervention messages will be developed: generic and behavioral. Using a randomized control design the investigators will evaluate the behavioral messages among women. This message testing protocol will help them determine if the messages are relevant, acceptable, comprehensible, memorable, and motivating for the target audience. The investigators' hypothesis is that the behavioral messages will receive more positive ratings than the generic messages. If so, they will be used to promote cancer screening and physical activity in future intervention studies.
- Conditions
- Colorectal Cancer
- Being tested
- Behavioral Messages, Generic Messages
- Keywords
- Colon, Cancer, Screening, Prevention, Information
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral MessagesOther
Participants will read 10 behavioral messages about colon cancer screening and physical activity.
Generic MessagesOther
Also called Control
Individuals will read 10 generic messages about colon cancer screening and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral Message Arm Receives: Other: Behavioral Messages |
| 2 | Active comparator | Generic Message Arm Receives: Other: Generic Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elaboration using the Elaboration Likelihood Scale
Measured: This study is to be completed in one session. The outcome is measured immediately after reading messages
Secondary outcomes (1)
Behavioral Intention to Engage in Colorectal Cancer Screening or Physical Activity
Measured: This study is to be completed in one session. The outcome is measured immediately after reading messages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Lucia A Leone, BA, Principal investigator, UNCMarci K Campbell, PhD, Study chair, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924690
- Sponsor's protocol ID
- UNC-CCEP
- Status last verified
- Jul 2010
- First submitted
- 6 Apr 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities in Colorectal Cancer Prevention Behaviors
- ClinicalTrials.gov ID
- NCT00924690
- Acronym / sponsor ID
- UNC-CCEP
- Conditions
- Colorectal Cancer
- Keywords
- Colon, Cancer, Screening, Prevention, Information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Jun 2009 (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 goal of this research study is to design messages which can help people learn more about how to prevent colon cancer. Eligible participants will be asked to review a series of short cancer prevention messages and share their opinions on them. Participants also need to fill out a short survey with questions on their background and attitudes and knowledge about physical activity and colon cancer. The whole study can be completed online and will take less than 1 hour. After completing the entire study, participants will receive $25.
If you are interested in participating in this study, please visit the following website:
https://surveys.chaicore.com/preventcancer/
Detailed description
The goal of this research is to develop and test potential intervention messages which can be used to help increase colon cancer prevention behaviors. Two sets of intervention messages will be developed: generic and behavioral. Using a randomized control design the investigators will evaluate the behavioral messages among women. This message testing protocol will help them determine if the messages are relevant, acceptable, comprehensible, memorable, and motivating for the target audience. The investigators' hypothesis is that the behavioral messages will receive more positive ratings than the generic messages. If so, they will be used to promote cancer screening and physical activity in future intervention studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Behavioral MessagesBehavioral Message Arm |
| 2 | Active comparator | Other: Generic MessagesGeneric Message Arm |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- Ages 50-80 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral MessagesParticipants will read 10 behavioral messages about colon cancer screening and physical activity. | Other | 1 |
| Generic MessagesAlso: ControlIndividuals will read 10 generic messages about colon cancer screening and physical activity. | Other | 2 |
Primary outcome
Elaboration using the Elaboration Likelihood Scale
Time frame: This study is to be completed in one session. The outcome is measured immediately after reading messages
1 secondary outcome
Behavioral Intention to Engage in Colorectal Cancer Screening or Physical Activity
Time frame: This study is to be completed in one session. The outcome is measured immediately after reading messages
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 7 Jul 2010.
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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.
Lucia A Leone, BA principal investigator
UNC
Marci K Campbell, PhD study chair
UNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Messages and Generic Messages in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill 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 2 inclusion and 0 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 7 Jul 2010. 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?
Elaboration using the Elaboration Likelihood Scale (time frame: This study is to be completed in one session. The outcome is measured immediately after reading messages). 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 7 Jul 2010.