Colorectal NeoplasmsCRCNCT02483832
Message Framing and Colorectal Cancer Screening
A study testing Educational materials in people with Colorectal Neoplasms, run by Duke University at 1 site in United States.
Trial summary
The main purpose of this study is to promote colorectal cancer (CRC) screening among individuals who have never been screened, with these individuals being members of a panel who participant in online studies. 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?
- Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 24 Aug 2015
- 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
- Age 50-75
- able to read and write English
- never had colorectal cancer
- never had colorectal cancer screening tests
Who cannot join
- History of colorectal cancer
- history of colorectal cancer screening tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
Durham, North Carolina, 27710
About this study
Official title: Effects of Message Framing and Risk Feedback on CRC Screening
The main purpose of this study is to promote colorectal cancer (CRC) screening among individuals who have never been screened, with these individuals being members of a panel who participant in online studies. The primary study goals are to test effects of the matching between level of comparative risk feedback for colorectal cancer (CDC), that is, how one's risk compares to others, and message framing (Gain vs. loss frame) on CRC screening intentions and screening as well as mediators of effects in the context of people who obtain CRC risk feedback and framing messages online (i.e., Internet).
Read the detailed description
- Purpose and objective: The investigators propose an online intervention to increase colorectal cancer screening among men and women ages 50 to 75 who have never been screened for this disease. The intervention consists of giving study participants information about their estimated risk of getting colorectal cancer followed by either a message emphasizing the benefits of getting screened (i.e., gain frame messages) or the disadvantages of not getting screened (loss frame messages). Before conducting the online intervention, the investigators will conduct a pilot study to validate the gain and loss frame messages.
- Study activities and population group: The pilot study activities involve recruiting 20 participants, screening for eligibility and conducting informed consent over the phone, randomizing them to receive either gain or loss frame messages, and instructing them to complete a survey with questions covering comprehension and framing manipulation checks. Data entry and survey activities will all be conducted through a secure REDCap project. Main study activities involve a pilot conducted by GfK involving 40 participants, 20 randomized to gain and 20 to the loss conditions, completing an online baseline survey and a post-intervention online survey. In addition, participants are to review: 1) educational materials on colorectal cancer and colorectal cancer screening, 2) review and respond to questions about their estimated risk of getting colorectal cancer, and 3) review and respond to questions about gain- or loss-framed messages. After the pilot, the full study will begin. Study activities will be the same as in the pilot, with the addition of a six month post-intervention online survey.
- Data analyses and risk/safety issues: Analyses will include descriptive statistics and use of linear and logistic regression analyses. Every effort will be made to ensure the confidentiality of the information collected. During the pilot study, the only PHI recorded is an email address for the purposes of conducting the online surveys, a physical address so that the study team can send a copy of the consent form, and information for payment. Demographic information and email address will be recorded during phone screening and entered into a secure REDCap database after the participant has given informed consent, and an internal record ID will be generated for the participant in REDCap that will be used to identify them throughout the study. Physical address and payment information will be recorded after informed consent. All paper data will be destroyed as soon as possible.
In the main study run by GfK, all data received by the key personnel from Gfk will be de-identified per GfK policy. There are no foreseeable physical risks; although some participants in the main study may be surprised by their risk estimate and react negatively (e.g., experience some anxiety) if the estimate is very high.
- Conditions
- Colorectal Neoplasms
- Being tested
- Educational materials
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materialsBehavioural
Educational materials about colorectal cancer and how to get screened will be presented to participants, with either gain- or loss-frame messages associated.
| Study group | Role | What they receive |
|---|---|---|
| Gain-frame | Active comparator | This group will receive messages about the benefits of colorectal cancer screening. Receives: Behavioral: Educational materials |
| Loss-frame | Active comparator | This group will receive messages about the disadvantages of not getting colorectal cancer screening. Receives: Behavioral: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening follow-up rate
Respondents will be required to complete a six-month follow-up survey and answer questions about any CRC screening they have sought out and/or completed since the intervention.
Measured: Six months
Secondary outcomes (1)
Changes in attitudes towards CRC and CRC screening as measured by survey
Respondents will be required to complete a baseline survey (with questions before the intervention and immediately after the intervention) and a six-month follow-up survey that includes the same questions on attitudes towards CRC and CRC screening. We will compare the results to assess changes in attitudes before intervention, immediately after intervention, and six months after intervention.
Measured: Baseline, immediately post-intervention, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completion24 Aug 2015
- Study completion24 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Duke 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
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483832
- Sponsor's protocol ID
- Pro00057568
- Acronym
- CRC
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Message Framing and Risk Feedback on CRC Screening
- ClinicalTrials.gov ID
- NCT02483832
- Acronym / sponsor ID
- CRC / Pro00057568
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 24 Aug 2015 (actual)
- Study completion
- 24 Aug 2015 (actual)
- First posted
- 29 Jun 2015 (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 main purpose of this study is to promote colorectal cancer (CRC) screening among individuals who have never been screened, with these individuals being members of a panel who participant in online studies. The primary study goals are to test effects of the matching between level of comparative risk feedback for colorectal cancer (CDC), that is, how one's risk compares to others, and message framing (Gain vs. loss frame) on CRC screening intentions and screening as well as mediators of effects in the context of people who obtain CRC risk feedback and framing messages online (i.e., Internet).
Detailed description
- Purpose and objective: The investigators propose an online intervention to increase colorectal cancer screening among men and women ages 50 to 75 who have never been screened for this disease. The intervention consists of giving study participants information about their estimated risk of getting colorectal cancer followed by either a message emphasizing the benefits of getting screened (i.e., gain frame messages) or the disadvantages of not getting screened (loss frame messages). Before conducting the online intervention, the investigators will conduct a pilot study to validate the gain and loss frame messages.
- Study activities and population group: The pilot study activities involve recruiting 20 participants, screening for eligibility and conducting informed consent over the phone, randomizing them to receive either gain or loss frame messages, and instructing them to complete a survey with questions covering comprehension and framing manipulation checks. Data entry and survey activities will all be conducted through a secure REDCap project. Main study activities involve a pilot conducted by GfK involving 40 participants, 20 randomized to gain and 20 to the loss conditions, completing an online baseline survey and a post-intervention online survey. In addition, participants are to review: 1) educational materials on colorectal cancer and colorectal cancer screening, 2) review and respond to questions about their estimated risk of getting colorectal cancer, and 3) review and respond to questions about gain- or loss-framed messages. After the pilot, the full study will begin. Study activities will be the same as in the pilot, with the addition of a six month post-intervention online survey.
- Data analyses and risk/safety issues: Analyses will include descriptive statistics and use of linear and logistic regression analyses. Every effort will be made to ensure the confidentiality of the information collected. During the pilot study, the only PHI recorded is an email address for the purposes of conducting the online surveys, a physical address so that the study team can send a copy of the consent form, and information for payment. Demographic information and email address will be recorded during phone screening and entered into a secure REDCap database after the participant has given informed consent, and an internal record ID will be generated for the participant in REDCap that will be used to identify them throughout the study. Physical address and payment information will be recorded after informed consent. All paper data will be destroyed as soon as possible.
In the main study run by GfK, all data received by the key personnel from Gfk will be de-identified per GfK policy. There are no foreseeable physical risks; although some participants in the main study may be surprised by their risk estimate and react negatively (e.g., experience some anxiety) if the estimate is very high.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gain-frame | Active comparator | Behavioral: Educational materialsThis group will receive messages about the benefits of colorectal cancer screening. |
| Loss-frame | Active comparator | Behavioral: Educational materialsThis group will receive messages about the disadvantages of not getting colorectal cancer screening. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-75
- able to read and write English
- never had colorectal cancer
- never had colorectal cancer screening tests
Key exclusion criteria (2 listed)
- History of colorectal cancer
- history of colorectal cancer screening tests
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 materialsEducational materials about colorectal cancer and how to get screened will be presented to participants, with either gain- or loss-frame messages associated. | Behavioural | Gain-frame, Loss-frame |
Primary outcome
CRC screening follow-up rate
Time frame: Six months
Respondents will be required to complete a six-month follow-up survey and answer questions about any CRC screening they have sought out and/or completed since the intervention.
1 secondary outcome
Changes in attitudes towards CRC and CRC screening as measured by survey
Time frame: Baseline, immediately post-intervention, six months
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 26 Jun 2017.
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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.
Isaac Lipkus, PhD principal investigator
Duke 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 Educational materials in people with Colorectal Neoplasms, run by Duke 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?
The sponsor lists 4 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 26 Jun 2017. 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?
CRC screening follow-up rate (time frame: Six 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 26 Jun 2017.