- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068052
Behavioral Economic Incentives and Cancer Health Risk Assessment
February 19, 2019 updated by: Shivan J Mehta, University of Pennsylvania
This is an RCT among UPHS employees between ages 50-64 comparing no incentive and a loss-framed incentive for completing cancer health risk assessment.
Those eligible will receive the phone number for direct colonoscopy scheduling, with the incentive arm receiving an additional unconditional incentive.
The primary outcome is completion of screening colonoscopy.
Secondary outcomes include scheduling of colonoscopy and completion of risk assessment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States.
Despite effective screening and treatment strategies, screening rates remain at 59-65%.
UPHS employees have similarly limited rates of CRC screening despite having awareness, access, and insurance coverage.
There is a need to identify those who are not up-to-date on screening and eligible for outreach in this population.
Financial incentives informed by behavioral economic principles could be used to encourage self-report about screening status and completion of CRC screening.
This research utilizes a digital health platform, Way to Health, to evaluate the feasibility of a cancer health risk assessment.
This is a single-center RCT among UPHS employees between ages 50-64 that will randomize eligible participants into one of two study arms: (1) no incentive to complete cancer health risk assessment (no incentive) or (2) loss-framed incentive to complete cancer health risk assessment (incentive).
Those that are eligible for screening will receive a direct access phone number to schedule colonoscopy, with an additional unconditional incentive for those in incentive arm.
The primary outcome is completion of screening colonoscopy, with secondary outcomes of colonoscopy scheduling and completion of risk assessment.
Study Type
Interventional
Enrollment (Actual)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- male and female UPHS employees between the ages 50-64
- those who live within 30 miles of the main endoscopy sites
Exclusion criteria:
-minimal exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: No incentive
Colon cancer risk assessment and direct access colonoscopy scheduling for those that are eligible.
|
Each participant will receive an email describing the importance of colorectal cancer screening and that they have been selected to receive a risk assessment.
They will directed to an online platform where they will be asked about age, family history, and prior screening history.
Those who are eligible for screening will be offered the VIP access phone number to schedule an appointment.
|
|
Experimental: Incentive
Loss-framed incentive to participate in risk assessment and additional unconditional pro-social incentive to complete colorectal cancer screening.
|
Each participant will receive an email describing the importance of colorectal cancer screening and that they have been selected to receive a risk assessment, for which they will received a loss-framed incentive.
They will directed to an online platform where they will be asked about age, family history, and prior screening history.
Those who are eligible for screening will be offered the VIP access phone number to schedule an appointment and will receive an additional unconditional pro-social incentive.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colonoscopy participation
Time Frame: 3 months
|
The percent of participants who complete screening colonoscopy
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colonoscopy scheduling
Time Frame: 3 months
|
The percent of participants who schedule screening colonoscopy
|
3 months
|
|
Risk assessment completion
Time Frame: 3 months
|
The percent of participants who complete risk assessment
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2017
Primary Completion (Actual)
August 8, 2017
Study Completion (Actual)
November 8, 2017
Study Registration Dates
First Submitted
February 24, 2017
First Submitted That Met QC Criteria
February 24, 2017
First Posted (Actual)
March 1, 2017
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 826739
- UL1TR001878 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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