Cancer of the ColonNCT03068052
Behavioral Economic Incentives and Cancer Health Risk Assessment
A study testing No incentive and Incentive in people with Cancer of the Colon, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer of the Colon
- What is being tested?
- No incentive and Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 8 Nov 2017
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female UPHS employees between the ages 50-64
- those who live within 30 miles of the main endoscopy sites
Who cannot join
- -minimal exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Cancer of the Colon
- Being tested
- No incentive, Incentive
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No incentiveBehavioural
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.
IncentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No incentive | Active comparator | Colon cancer risk assessment and direct access colonoscopy scheduling for those that are eligible. Receives: Behavioral: No incentive |
| Incentive | Experimental | Loss-framed incentive to participate in risk assessment and additional unconditional pro-social incentive to complete colorectal cancer screening. Receives: Behavioral: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy participation
The percent of participants who complete screening colonoscopy
Measured: 3 months
Secondary outcomes (2)
Colonoscopy scheduling
The percent of participants who schedule screening colonoscopy
Measured: 3 months
Risk assessment completion
The percent of participants who complete risk assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start8 May 2017
- Primary completion8 Aug 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the ColonStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068052
- Sponsor's protocol ID
- 826739
- Other IDs
- UL1TR001878
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Reitz C, Niewood T, Volpp KG, Asch DA. Effect of Behavioral Economic Incentives for Colorectal Cancer Screening in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1635-1641.e1. doi: 10.1016/j.cgh.2020.06.047. Epub 2020 Jul 2.
PubMed 32623005
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Incentives and Cancer Health Risk Assessment
- ClinicalTrials.gov ID
- NCT03068052
- Acronym / sponsor ID
- 826739
- Conditions
- Cancer of the Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No incentive | Active comparator | Behavioral: No incentiveColon cancer risk assessment and direct access colonoscopy scheduling for those that are eligible. |
| Incentive | Experimental | Behavioral: IncentiveLoss-framed incentive to participate in risk assessment and additional unconditional pro-social incentive to complete colorectal cancer screening. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male and female UPHS employees between the ages 50-64
- those who live within 30 miles of the main endoscopy sites
Key exclusion criteria (1 listed)
- -minimal exclusion criteria
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 |
|---|---|---|
| No incentiveEach 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. | Behavioural | No incentive |
| IncentiveEach 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. | Behavioural | Incentive |
Primary outcome
Colonoscopy participation
Time frame: 3 months
The percent of participants who complete screening colonoscopy
2 secondary outcomes
Colonoscopy scheduling
Time frame: 3 months
Risk assessment completion
Time frame: 3 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 20 Feb 2019.
- Derived from this study: PubMed 32623005Mehta SJ, Reitz C, Niewood T, Volpp KG, Asch DA. Effect of Behavioral Economic Incentives for Colorectal Cancer Screening in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1635-1641.e1. doi: 10.1016/j.cgh.2020.06.047. Epub 2020 Jul 2.
- Individual participant dataSharing planned: No
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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.
Shivan Mehta, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No incentive and Incentive in people with Cancer of the Colon, run by University of Pennsylvania 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 2 inclusion and 1 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 20 Feb 2019. 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?
Colonoscopy participation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068052, which also lists 1 linked publication.
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 20 Feb 2019.