Cancer of the ColonNCT02660671
Behavioral Economic Approaches to Increase Colorectal Cancer Screening
A study testing Email outreach, Active choice and Financial incentive in people with Cancer of the Colon, run by University of Pennsylvania.
Trial summary
This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening through email outreach, including usual email communication, active choice, and active choice + financial incentive. Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Cancer of the Colon
- What is being tested?
- Email outreach, Active choice and Financial incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male and female employees of the University of Pennsylvania Health System who live within 30 miles of a health system endoscopy center.
Who cannot join
None listed.
About this study
This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening through email outreach, including usual email communication, active choice, and active choice + financial incentive.
Read the detailed description
This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening. The investigators will randomize a cohort of employees between the ages of 50-64 to 3 arms of email communications: a.) Usual email communication; b.) Active choice- usual care + the ability to pre-commit directly through a web form; c.) Financial incentive- usual care + active choice + financial incentive for completion.
- Conditions
- Cancer of the Colon
- Being tested
- Email outreach, Active choice, Financial 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.
Email outreachBehavioural
Subjects will receive an email describing the importance of colorectal cancer screening and that s/he has been selected to participate in this VIP concierge service.
Active choiceBehavioural
S/he will receive the ability to pre-commit and choose from 3 different appointment slots by clicking directly on the email.
Financial incentiveBehavioural
The participant will receive the offering of $100 if s/he follows through with screening colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Email outreach Receives: Behavioral: Email outreach |
| Active choice | Experimental | Email outreach + active choice Receives: Behavioral: Email outreach; Behavioral: Active choice |
| Financial incentive + Active choice | Experimental | Email outreach + active choice + financial incentive Receives: Behavioral: Email outreach; Behavioral: Active choice; Behavioral: Financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy participation
The percentage of participants who follow through with screening colonoscopy.
Measured: 3 months
Secondary outcomes (2)
Email engagement
The percentage of participants who respond to the email (arm 2 and 3).
Measured: 3 months
Scheduling of colonoscopy
The percentage of participants who schedule a procedure.
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 posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionSep 2016
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660671
- Sponsor's protocol ID
- 822504
- Status last verified
- May 2017
- First submitted
- 19 Jan 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mehta SJ, Feingold J, Vandertuyn M, Niewood T, Cox C, Doubeni CA, Volpp KG, Asch DA. Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial. Gastroenterology. 2017 Nov;153(5):1227-1229.e2. doi: 10.1053/j.gastro.2017.07.015. Epub 2017 Jul 20.
PubMed 28734830
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Approaches to Increase Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT02660671
- Acronym / sponsor ID
- 822504
- Conditions
- Cancer of the Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,250 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- 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 aimed at testing different population-based approaches to increasing colorectal cancer screening through email outreach, including usual email communication, active choice, and active choice + financial incentive.
Detailed description
This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening. The investigators will randomize a cohort of employees between the ages of 50-64 to 3 arms of email communications: a.) Usual email communication; b.) Active choice- usual care + the ability to pre-commit directly through a web form; c.) Financial incentive- usual care + active choice + financial incentive for completion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Email outreachEmail outreach |
| Active choice | Experimental | Behavioral: Email outreach, Behavioral: Active choiceEmail outreach + active choice |
| Financial incentive + Active choice | Experimental | Behavioral: Email outreach, Behavioral: Active choice, Behavioral: Financial incentiveEmail outreach + active choice + financial incentive |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female employees of the University of Pennsylvania Health System who live within 30 miles of a health system endoscopy center.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Email outreachSubjects will receive an email describing the importance of colorectal cancer screening and that s/he has been selected to participate in this VIP concierge service. | Behavioural | Active choice, Financial incentive + Active choice, Usual care |
| Active choiceS/he will receive the ability to pre-commit and choose from 3 different appointment slots by clicking directly on the email. | Behavioural | Active choice, Financial incentive + Active choice |
| Financial incentiveThe participant will receive the offering of $100 if s/he follows through with screening colonoscopy. | Behavioural | Financial incentive + Active choice |
Primary outcome
Colonoscopy participation
Time frame: 3 months
The percentage of participants who follow through with screening colonoscopy.
2 secondary outcomes
Email engagement
Time frame: 3 months
Scheduling of colonoscopy
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 5 May 2017.
- Derived from this study: PubMed 28734830Mehta SJ, Feingold J, Vandertuyn M, Niewood T, Cox C, Doubeni CA, Volpp KG, Asch DA. Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial. Gastroenterology. 2017 Nov;153(5):1227-1229.e2. doi: 10.1053/j.gastro.2017.07.015. Epub 2017 Jul 20.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
A study testing Email outreach, Active choice and Financial incentive in people with Cancer of the Colon, run by University of Pennsylvania.
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 1 inclusion and 0 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 NCT02660671, 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 5 May 2017.