Cancer of the ColonNCT02929186
Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
A study testing Opt-In Outreach and Opt-Out Outreach in people with Cancer of the Colon, run by University of Pennsylvania.
Trial summary
This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT). 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 the Colon
- What is being tested?
- Opt-In Outreach and Opt-Out Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 15 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 50 to 74 years old
- Has received care at the Division of Internal Medicine
- Due for screening
- Asymptomatic for colorectal cancer (CRC)
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 iron deficiency anemia
- Has 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
About this study
This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
Read the detailed description
This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:
- Opt-In - subject must actively choose to receive a home FIT kit.
- Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.
- Conditions
- Cancer of the Colon
- Being tested
- Opt-In Outreach, Opt-Out Outreach
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-In OutreachBehavioural
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.
Opt-Out OutreachBehavioural
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.
| Study group | Role | What they receive |
|---|---|---|
| Opt-In | Experimental | Opt-In Outreach Receives: Behavioral: Opt-In Outreach |
| Opt-Out | Experimental | Opt-Out Outreach Receives: Behavioral: Opt-Out Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT Completion Rate
The percentage of participants who successfully complete the FIT.
Measured: 3 months
Secondary outcomes (1)
Mail/Electronic Message Engagement
The percentage of people who send responses using either mail or electronic messaging.
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 posted11 Oct 2016 (estimated)
- Study startJan 2017
- Primary completion15 Jun 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 314 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
- NCT02929186
- Sponsor's protocol ID
- 826047
- Status last verified
- May 2020
- First submitted
- 7 Oct 2016
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
- ClinicalTrials.gov ID
- NCT02929186
- Acronym / sponsor ID
- 826047
- Conditions
- Cancer of the Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 11 Oct 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 a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
Detailed description
This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:
- Opt-In - subject must actively choose to receive a home FIT kit.
- Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt-In | Experimental | Behavioral: Opt-In OutreachOpt-In Outreach |
| Opt-Out | Experimental | Behavioral: Opt-Out OutreachOpt-Out Outreach |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 50 to 74 years old
- Has received care at the Division of Internal Medicine
- Due for screening
- Asymptomatic for colorectal cancer (CRC)
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 |
|---|---|---|
| Opt-In OutreachSubjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening. | Behavioural | Opt-In |
| Opt-Out OutreachSubjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default. | Behavioural | Opt-Out |
Primary outcome
FIT Completion Rate
Time frame: 3 months
The percentage of participants who successfully complete the FIT.
1 secondary outcome
Mail/Electronic Message Engagement
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 26 May 2020.
- 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
Chyke Doubeni, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Opt-In Outreach and Opt-Out Outreach 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 4 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 26 May 2020. 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?
FIT Completion Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2020.