Cancer of the ColonNCT03072095
Colorectal Cancer Screening in a Community Health Setting
A study testing Text-only and Text + Lottery in people with Cancer of the Colon, run by University of Pennsylvania at 1 site in United States.
Trial summary
This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and… 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?
- Text-only and Text + Lottery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 3 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 and 74 years old
- Has active medical insurance
- Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
- Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
- Asymptomatic for CRC
Who cannot join
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and 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. Crohns disease, ulcerative colitis)
- Has a history of colon polyps
- Has had a colectomy
Show all 18Show fewer
- Has a first-degree 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 recent 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 liver cirrhosis
- Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
- Does not use a mobile phone enabled to send and receive text messages
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Practice & Counseling Network - Health Annex
Philadelphia, Pennsylvania, 19142
About this study
Official title: Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.
Read the detailed description
This is a single-center RCT at the Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms:
- text messaging outreach (text)
- text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery).
Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.
- Conditions
- Cancer of the Colon
- Being tested
- Text-only, Text + Lottery
- Keywords
- Colorectal Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Rectal Diseases
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-onlyBehavioural
Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.
Text + LotteryBehavioural
Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.
| Study group | Role | What they receive |
|---|---|---|
| Text-only | Experimental | Text-only outreach Receives: Behavioral: Text-only |
| Text + Lottery | Experimental | Text outreach + financial incentive Receives: Behavioral: Text + Lottery |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT completion within 3 months
The percentage of participants who successfully complete the FIT
Measured: 3 months
Secondary outcomes (1)
Response to text-based CRC screening outreach
The percentage of people who respond to text message
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 posted7 Mar 2017
- Study start17 Apr 2017
- Primary completion3 Aug 2017
- Study completion3 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- 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
- NCT03072095
- Sponsor's protocol ID
- 826576
- Status last verified
- Feb 2019
- First submitted
- 23 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
- Undecided
Publications
Mehta SJ, Oyalowo A, Reitz C, Dean O, McAuliffe T, Asch DA, Doubeni CA. Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial. Prev Med Rep. 2020 May 8;19:101114. doi: 10.1016/j.pmedr.2020.101114. eCollection 2020 Sep.
PubMed 32477853
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
- Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
- ClinicalTrials.gov ID
- NCT03072095
- Acronym / sponsor ID
- 826576
- Conditions
- Cancer of the Colon
- Keywords
- Colorectal Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 7 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 randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.
Detailed description
This is a single-center RCT at the Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms:
- text messaging outreach (text)
- text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery).
Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-only | Experimental | Behavioral: Text-onlyText-only outreach |
| Text + Lottery | Experimental | Behavioral: Text + LotteryText outreach + financial incentive |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 50 and 74 years old
- Has active medical insurance
- Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
- Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
- Asymptomatic for CRC
Key exclusion criteria (18 listed)
- Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and 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. Crohns disease, ulcerative colitis)
- Has a history of colon polyps
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 |
|---|---|---|
| Text-onlySubjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit. | Behavioural | Text-only |
| Text + LotterySubjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit. | Behavioural | Text + Lottery |
Primary outcome
FIT completion within 3 months
Time frame: 3 months
The percentage of participants who successfully complete the FIT
1 secondary outcome
Response to text-based CRC screening outreach
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 32477853Mehta SJ, Oyalowo A, Reitz C, Dean O, McAuliffe T, Asch DA, Doubeni CA. Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial. Prev Med Rep. 2020 May 8;19:101114. doi: 10.1016/j.pmedr.2020.101114. eCollection 2020 Sep.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-only and Text + Lottery 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 5 inclusion and 18 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?
FIT completion within 3 months (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 NCT03072095, 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.