Cancer of ColonNCT03246438
Choice Architecture and Colorectal Cancer Screening Outreach
A study testing Colonoscopy only, Colonoscopy outreach + mailed FIT follow-up and Colonoscopy + Mailed FIT outreach and follow-up in people with Cancer of Colon, run by University of Pennsylvania at 1 site in United States.
Trial summary
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates)… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer of Colon
- What is being tested?
- Colonoscopy only, Colonoscopy outreach + mailed FIT follow-up and Colonoscopy + Mailed FIT outreach and follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 14 Jul 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 50 and 74 years old
- Has a primary care provider who is a University City or Valley Forge Family Medicine provider
- Has had at least 2 office visits at either practice
- Is due for colorectal cancer screening
- Is asymptomatic for CRC
- Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
Who cannot join
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
- Has a history of CRC or colonic polyps
- Has a history of GI cancer
- Has a history of confirmed Inflammatory Bowel Disease (IBD)
- has a history of colitis other than Crohns disease or ulcerative colitis)
- Has a first degree relative that has been diagnosed with CRC
Show all 17Show fewer
- Has had a colectomy
- Has been diagnosed with Familial Adenomatous Polyposis (FAP)
- Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
- Has iron-deficiency anemia
- Has a history of lower GI bleeding
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has cirrhosis
- Has heart failure
- Has dementia
- Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
Read the detailed description
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:
Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
- Conditions
- Cancer of Colon
- Being tested
- Colonoscopy only, Colonoscopy outreach + mailed FIT follow-up, Colonoscopy + Mailed FIT outreach and follow-up
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy onlyBehavioural
Also called Control
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.
Colonoscopy outreach + mailed FIT follow-upBehavioural
Also called Sequential Choice
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.
Colonoscopy + Mailed FIT outreach and follow-upBehavioural
Also called Active Choice
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Colonoscopy only outreach and follow-up Receives: Behavioral: Colonoscopy only |
| Sequential Choice | Experimental | Colonoscopy outreach + mailed FIT follow-up Receives: Behavioral: Colonoscopy outreach + mailed FIT follow-up |
| Active Choice | Experimental | Colonoscopy + mailed FIT outreach and follow-up Receives: Behavioral: Colonoscopy + Mailed FIT outreach and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC screening completion
The percentage of participants who successfully complete FIT or colonoscopy
Measured: 4 months
Secondary outcomes (1)
Choice of screening test
The percentage of participants who choose either screening method (FIT vs. colonoscopy)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start14 Nov 2017
- Primary completion14 Mar 2018
- Study completion14 Jul 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 Cancer of 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
- 423 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 PennsylvaniaChyke Doubeni, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246438
- Sponsor's protocol ID
- 827818
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mehta SJ, Induru V, Santos D, Reitz C, McAuliffe T, Orellana C, Volpp KG, Asch DA, Doubeni CA. Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e1910305. doi: 10.1001/jamanetworkopen.2019.10305.
PubMed 31469393
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
- Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03246438
- Acronym / sponsor ID
- 827818
- Conditions
- Cancer of Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 11 Aug 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 pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
Detailed description
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:
Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Colonoscopy onlyColonoscopy only outreach and follow-up |
| Sequential Choice | Experimental | Behavioral: Colonoscopy outreach + mailed FIT follow-upColonoscopy outreach + mailed FIT follow-up |
| Active Choice | Experimental | Behavioral: Colonoscopy + Mailed FIT outreach and follow-upColonoscopy + mailed FIT outreach and follow-up |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 50 and 74 years old
- Has a primary care provider who is a University City or Valley Forge Family Medicine provider
- Has had at least 2 office visits at either practice
- Is due for colorectal cancer screening
- Is asymptomatic for CRC
Key exclusion criteria (17 listed)
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
- Has a history of CRC or colonic polyps
- Has a history of GI cancer
- Has a history of confirmed Inflammatory Bowel Disease (IBD)
- has a history of colitis other than Crohns 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 |
|---|---|---|
| Colonoscopy onlyAlso: ControlSubjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy. | Behavioural | Control |
| Colonoscopy outreach + mailed FIT follow-upAlso: Sequential ChoiceSubjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit. | Behavioural | Sequential Choice |
| Colonoscopy + Mailed FIT outreach and follow-upAlso: Active ChoiceSubjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent. | Behavioural | Active Choice |
Primary outcome
CRC screening completion
Time frame: 4 months
The percentage of participants who successfully complete FIT or colonoscopy
1 secondary outcome
Choice of screening test
Time frame: 4 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 31469393Mehta SJ, Induru V, Santos D, Reitz C, McAuliffe T, Orellana C, Volpp KG, Asch DA, Doubeni CA. Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e1910305. doi: 10.1001/jamanetworkopen.2019.10305.
- 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
Chyke Doubeni, 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 Colonoscopy only, Colonoscopy outreach + mailed FIT follow-up and Colonoscopy + Mailed FIT outreach and follow-up in people with Cancer of 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 6 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.
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?
CRC screening completion (time frame: 4 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 NCT03246438, 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.