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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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
  1. 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.
  2. 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.
  3. 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.

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 groups in NCT02483832
Study groupRoleWhat they receive
Gain-frameActive comparatorThis group will receive messages about the benefits of colorectal cancer screening.
Receives: Behavioral: Educational materials
Loss-frameActive comparatorThis 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.

  1. 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)
  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.

  1. First posted29 Jun 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion24 Aug 2015
  4. Study completion24 Aug 2015

Resources

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)
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

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.

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Message Framing and Colorectal Cancer Screening | AzTrials