- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06972667
- Original Trial
Interventions to Decrease Health Information Avoidance
Interventions to Decrease Cancer Information Avoidance
Study Overview
Status
Conditions
Detailed Description
The study will test the efficacy and mediating mechanisms of brief video interventions including elements demonstrated to be effective in reducing health information avoidance (self-efficacy boosting, humor, calm affect induction). It is expected that the videos to benefit people who typically avoid health information yet still be beneficial for people who do not avoid health information, thus being suitable for dissemination to general audiences. It is hypothesized that the interventions will strengthen intentions to be screened, increase colorectal cancer risk information seeking and increase screening.
Following recommended practices, the two intervention arms and the control arm will include multiple versions of the videos to control for actor effects. All intervention videos operationalize the same psychological mechanisms but are delivered by 4 different actors and promote either colonoscopy or stool tests. The 8 parallel intervention and 4 control videos will be treated as random effects.
The intervention videos will be tested in members of the Ipsos panel who are not adherent to colorectal cancer screening guidelines, half of whom will be selected because they tend to avoid colorectal cancer information. Effects of the intervention videos will be compared to those of an attentional control video about food safety.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14222
- University at Buffalo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- between the ages of 45 and 75 years
- never diagnosed with colorectal cancer
- non-adherent to colorectal cancer screening guidelines
- half will have a score at or greater than the mid-point on the colorectal cancer information avoidance scale (≥2.5) on the pre-screening survey such that half of the sample are people who tend to avoid colorectal cancer information
Exclusion Criteria:
- not between the ages of 45 and 75 years
- have been diagnosed with colorectal cancer
- adherent to colorectal cancer screening guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video to promote colonoscopy
Participants will view a brief video promoting colonoscopy with self-efficacy enhancement, humor and calm affect induction
|
This video contains elements designed to engage and persuade people who tend to avoid colorectal cancer information to have a colonoscopy.
Psychological elements include self-efficacy boosting, humor, and calming affect induction.
|
|
Experimental: Video to promote screening for colorectal cancer with home tests
Participants will view a brief video promoting colorectal cancer home testing with self-efficacy enhancement, humor and calm affect induction
|
This video contains elements designed to engage and persuade people who tend to avoid colorectal cancer information to screen for colorectal cancer with a home test.
Psychological elements include self-efficacy boosting, humor, and calming affect induction.
|
|
No Intervention: Attentional control video
The attentional control video will be about food safety and will be the same length and include the same actors and music.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength of screening intentions
Time Frame: Day 1
|
Participants will rate their intention to be screened with the item, "I intend to get checked for colon cancer within the next 6 months" on a scale from 1 to 4 with 4 being stronger intentions.
|
Day 1
|
|
Strength of intentions to talk to a health care provider about being screened for colorectal cancer
Time Frame: Day 1
|
This outcome will be assessed with the item, "I will talk to a health care provider about getting checked for colon cancer within the next 6 months".
|
Day 1
|
|
Proportion of participants who seek personal risk information
Time Frame: Day 1
|
Participants will be asked whether they want to be redirected at the end of the study to complete the online Siteman Cancer Center colorectal cancer risk calculator.
|
Day 1
|
|
Proportion of participants screened for colorectal cancer after 9 months
Time Frame: At least 9 months after start of study
|
The researchers will assess whether participants have been screened for colorectal cancer in the 9 months since participating in the intervention phase of the study.
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At least 9 months after start of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy for colorectal cancer screening
Time Frame: Day 1
|
Sel-efficacy will be assessed with 2 items with which participants rate their confidence in arranging to get screened and completing a screening test on a scale ranging from 0 to 10, with 10 indicating greater self-efficacy.
|
Day 1
|
|
Positive and negative affect
Time Frame: Day 1
|
Positive and negative affect will be assessed with the Positive and Negative Affect Schedule Short Form (PANAS-SF).
Scores range from 1 to 5, with higher scores indicating more of a given affect.
|
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heather Orom Associate Professor, PhD, University at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00009059
- R01CA276430 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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