Colorectal CancerCRCSONCT02594150
Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
A study testing Financial Incentive in people with Colorectal Cancer, run by University of Pennsylvania.
Trial summary
A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Financial Incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 897 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 50 to 75 years old
- Has had at least two visits at Penn Family Care Within the past two years - Due for screening
- Asymptomatic for colorectal cancer (CRC)
- Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
- Have a primary care provider in Penn Family Care
Who cannot join
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
- Has a history of CRC
- Has a history of other GI cancer
- Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
- Has history of colitis other than Crohn's disease or ulcerative colitis
- Has had a colectomy
Show all 17Show fewer
- Has a relative that has been diagnosed with CRC
- Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
- Has been diagnosed with Familial Adenomatous Polyposis (FAP)
- Has anemia (iron-deficient or general/unspecified)
- Has history of lower GI bleeding
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has had congestive heart failure
- Has dementia
- Has cirrhosis or end stage liver disease
- Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
About this study
A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.
Read the detailed description
This is a single center 4-arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives. Potentially eligible subjects will be identified via a data abstraction by Penn Data Store. We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the data abstraction using PennChart to confirm eligibility until 1,080 patients are identified. We will then randomize these 1,080 patients to one of four arms during the intervention phase.
- Arm 1: mailed FIT kit (usual care)
- Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive)
- Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two months (conditional fixed incentive)
- Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is returned within two months (conditional lottery incentive) All 1,080 subjects will receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks after the kit was mailed to the subject. Subjects whose FIT results are not recorded in PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to the subject. Subjects will receive follow-up regardless of the arm to which they are randomized.
A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this sub-sample. This phone call will occur after the intervention and follow-up phases are completed. Analysis will occur after the sub-sample questionnaire phase is completed.
- Conditions
- Colorectal Cancer
- Being tested
- Financial Incentive
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentiveOther
Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Each FIT kit will include a tube in which to deposit the stool sample, directions on how to collect and mail the sample, a letter about colorectal cancer screening, a Labcorp requisition form, and a pre-paid return envelope. |
| unconditional fixed incentive | Experimental | This arm will receive a FIT kit as described in the mailed FIT arm and will also receive a financial incentive in the form of a gift card and a note explaining that this gift card is a token of our appreciation for completing the kit. Receives: Other: Financial Incentive |
| conditional fixed incentive | Experimental | This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit. Receives: Other: Financial Incentive |
| conditional lottery incentive | Experimental | This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will be entered in a 1/10 chance lottery to receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit. Receives: Other: Financial Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in return rate of completed FIT
An increase in return rate of completed FIT between intervention arms when compared to the control arm
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2018
- Study completionSep 2018
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 Colorectal CancerStudies 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
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivan Mehta, MD MBA MSHP, Principal investigator, University of PennsylvaniaChyke Doubeni, MD MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594150
- Sponsor's protocol ID
- 823388
- Acronym
- CRCSO
- Status last verified
- Feb 2019
- First submitted
- 29 Oct 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehta SJ, Pepe RS, Gabler NB, Kanneganti M, Reitz C, Saia C, Teel J, Asch DA, Volpp KG, Doubeni CA. Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191156. doi: 10.1001/jamanetworkopen.2019.1156.
PubMed 30901053
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
- Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
- ClinicalTrials.gov ID
- NCT02594150
- Acronym / sponsor ID
- CRCSO / 823388
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Nov 2015 (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.
A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.
Detailed description
This is a single center 4-arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives. Potentially eligible subjects will be identified via a data abstraction by Penn Data Store. We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the data abstraction using PennChart to confirm eligibility until 1,080 patients are identified. We will then randomize these 1,080 patients to one of four arms during the intervention phase.
- Arm 1: mailed FIT kit (usual care)
- Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive)
- Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two months (conditional fixed incentive)
- Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is returned within two months (conditional lottery incentive) All 1,080 subjects will receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks after the kit was mailed to the subject. Subjects whose FIT results are not recorded in PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to the subject. Subjects will receive follow-up regardless of the arm to which they are randomized.
A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this sub-sample. This phone call will occur after the intervention and follow-up phases are completed. Analysis will occur after the sub-sample questionnaire phase is completed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Each FIT kit will include a tube in which to deposit the stool sample, directions on how to collect and mail the sample, a letter about colorectal cancer screening, a Labcorp requisition form, and a pre-paid return envelope. |
| unconditional fixed incentive | Experimental | Other: Financial IncentiveThis arm will receive a FIT kit as described in the mailed FIT arm and will also receive a financial incentive in the form of a gift card and a note explaining that this gift card is a token of our appreciation for completing the kit. |
| conditional fixed incentive | Experimental | Other: Financial IncentiveThis arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit. |
| conditional lottery incentive | Experimental | Other: Financial IncentiveThis arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will be entered in a 1/10 chance lottery to receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 50 to 75 years old
- Has had at least two visits at Penn Family Care Within the past two years - Due for screening
- Asymptomatic for colorectal cancer (CRC)
- Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
- Have a primary care provider in Penn Family Care
Key exclusion criteria (17 listed)
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
- Has a history of CRC
- Has a history of other GI cancer
- Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
- Has history of colitis other than Crohn's disease or ulcerative colitis
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 |
|---|---|---|
| Financial IncentiveFinancial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention. | Other | conditional fixed incentive, conditional lottery incentive, unconditional fixed incentive |
Primary outcome
Increase in return rate of completed FIT
Time frame: 2 months
An increase in return rate of completed FIT between intervention arms when compared to the control arm
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 30901053Mehta SJ, Pepe RS, Gabler NB, Kanneganti M, Reitz C, Saia C, Teel J, Asch DA, Volpp KG, Doubeni CA. Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191156. doi: 10.1001/jamanetworkopen.2019.1156.
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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 MBA MSHP principal investigator
University of Pennsylvania
Chyke Doubeni, MD MPH principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentive in people with Colorectal Cancer, 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 5 inclusion and 17 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.
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?
Increase in return rate of completed FIT (time frame: 2 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 NCT02594150, 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.