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Message Framing and Colorectal Cancer Screening (CRC)

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational materials
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 50-75
  • able to read and write English
  • never had colorectal cancer
  • never had colorectal cancer screening tests

Exclusion Criteria:

  • History of colorectal cancer
  • history of colorectal cancer screening tests

Sites / Locations

  • Duke University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gain-frame

Loss-frame

Arm Description

This group will receive messages about the benefits of colorectal cancer screening.

This group will receive messages about the disadvantages of not getting colorectal cancer screening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 25, 2015
Last Updated
June 23, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02483832
Brief Title
Message Framing and Colorectal Cancer Screening
Acronym
CRC
Official Title
Effects of Message Framing and Risk Feedback on CRC Screening
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
August 24, 2015 (Actual)
Study Completion Date
August 24, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gain-frame
Arm Type
Active Comparator
Arm Description
This group will receive messages about the benefits of colorectal cancer screening.
Arm Title
Loss-frame
Arm Type
Active Comparator
Arm Description
This group will receive messages about the disadvantages of not getting colorectal cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
Educational materials about colorectal cancer and how to get screened will be presented to participants, with either gain- or loss-frame messages associated.
Primary Outcome Measure Information:
Title
CRC screening follow-up rate
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Changes in attitudes towards CRC and CRC screening as measured by survey
Description
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.
Time Frame
Baseline, immediately post-intervention, six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 50-75 able to read and write English never had colorectal cancer never had colorectal cancer screening tests Exclusion Criteria: History of colorectal cancer history of colorectal cancer screening tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Lipkus, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University School of Nursing
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Message Framing and Colorectal Cancer Screening

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