Bowel CancerNCT03479645
Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT
A study testing Serial text messages and mailed FIT kit in people with Bowel Cancer and Colon Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Cancer, Colon Cancer
- What is being tested?
- Serial text messages and mailed FIT kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 16 Jun 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
- aged 50-74
- at least 1 clinic visit to the FPCN within the previous 12 months
- due or overdue for colorectal screening
- Asymptomatic for bowel cancer
- mobile phone number available
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) Irritable bowel syndrome does not exclude patients.
- Has history of colitis other than Crohns disease or ulcerative colitis
- Has had a colectomy
Show all 13Show fewer
- Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
- Has been diagnosed with Familial Adenomatous Polyposis (FAP)
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has dementia
- Has liver cirrhosis
- 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
Family Practice and Councelling Network
Philadelphia, Pennsylvania, 19142
About this study
Official title: Can a Multimodal Approach Using SMS Reminders and an Opt-out Mailed FIT Kits Improve Participation in Colorectal Cancer Screening? A Single Center Randomized Controlled Trial
This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary outcome is the rate of FIT kits being returned at 12 weeks.
Read the detailed description
It is estimated that colorectal cancer (CRC) screening can reduce the risk of dying from bowel cancer by approximately 15%. Yet despite this, the national participation rate is only approximately 62.9%, highlighting that the national target of 70.5% set out in the Healthy People 2020 Objectives remains well out of reach. The US Preventative Task Force (USPSTF) recommends colorectal screening for adults aged 50-75 years through either annual fecal occult blood testing (FOBT), flexible sigmoidoscopy every 5 years or colonoscopy every 10 years. However, many service providers rely on the opportunistic offer of screening at existing health touch-points. This requires the patient to see their healthcare provider, usually for a different clinical reason, the provider to recognize that the patient is overdue for CRC screening and the provider to recommend and book the patient for CRC screening. This process identifies a number of barriers encountered at the system, provider and patient level, to completing a screening test regularly. Furthermore, much evidence indicates that public participation in colorectal screening is heavily influences by socioeconomic factors. Lower participation rates are seen in individuals without health insurance, without a medical home, who are more deprived and from ethnic minority groups. These individuals are more likely to present with later stage disease and experience poorer outcomes. Fecal immunochemistry testing (FIT) is a stool sample based test kit that uses antibodies to detect the human haemoglobin protein in the stool sample and can be completed in the privacy of the home. Research has showed that mailed home test kits such as FOBT or FIT kits can improve CRC participation by reducing the effort required to see a provider in order to arrange CRC screening. Evidence has also shown that text message reminders can improve participation in cancer screening. Furthermore, the message content of text messages can differentially change behavior, for example reducing the 'did not attend rate' in hospital outpatient appointments but also in the context of participation in cervical cancer screening. Therefore this trial will test a multimodal outreach approach, which uses serial SMS reminders with different word contents and mailed FIT kits on the participation rates of CRC screening.
- Conditions
- Bowel Cancer, Colon Cancer
- Being tested
- Serial text messages and mailed FIT kit
- Keywords
- Colon cancer, Bowel cancer, Cancer screening, text message, Fecal immunochemistry test (FIT), opt-out, behavioral intervention
- Medical subject headings
- Intestinal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial text messages and mailed FIT kitBehavioural
- Pre-alert SMS offering Opt-out of mailed FIT kit
- Mailed home FIT kit
- SMS A - Reciprocity message
- SMS B - Offer for second FIT kit if lost/did not receive
- Plus SMS A + C if second mailed FIT is requested.
- SMS C - Salience message
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic. |
| Intervention | Experimental | Serial text messages and mailed FIT kit Receives: Behavioral: Serial text messages and mailed FIT kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal screening rate
The rate patients with who completed colorectal screening within the trial period
Measured: 12 weeks
Secondary outcomes (9)
Per Protocol analysis: Colorectal screening rate
The rate of FIT kit return by trial arm in individuals who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
Measured: 12 weeks
FIT kit return rate
The rate of FIT kit return by trial arm
Measured: 12 weeks
Per protocol analysis: FIT kit return rate
The rate of FIT kit return by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
Measured: 12 weeks
colonoscopy completion rate
The rate of colonoscopy within the trial period by trial arm
Measured: 12 weeks
Per protocol analysis: colonoscopy completion rate
The rate of colonoscopy within the trial period by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
Measured: 12 weeks
Colorectal screening return rate by gender
Uptake of screening and FIT return by gender
Measured: 12 weeks
FIT return rate by gender
Uptake of screening and FIT return by gender
Measured: 12 weeks
Colorectal screening rate by insurance status
Uptake of screening by insurance status
Measured: 12 weeks
FIT kit return rate by insurance status
FIT return by insurance status
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start23 Mar 2018
- Primary completion16 Jun 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bowel 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
- Participant
- Enrolment
- 440 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
- NCT03479645
- Sponsor's protocol ID
- 828624
- Status last verified
- Jul 2019
- First submitted
- 23 Feb 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.
PubMed 8942775Halpern MT, Ward EM, Pavluck AL, Schrag NM, Bian J, Chen AY. Association of insurance status and ethnicity with cancer stage at diagnosis for 12 cancer sites: a retrospective analysis. Lancet Oncol. 2008 Mar;9(3):222-31. doi: 10.1016/S1470-2045(08)70032-9. Epub 2008 Feb 20.
PubMed 18282806Clegg LX, Li FP, Hankey BF, Chu K, Edwards BK. Cancer survival among US whites and minorities: a SEER (Surveillance, Epidemiology, and End Results) Program population-based study. Arch Intern Med. 2002 Sep 23;162(17):1985-93. doi: 10.1001/archinte.162.17.1985.
PubMed 12230422Institute NC. Caner trends progress reprot; Colorectal Screening. https://progressreport.cancer.gov/detection/colorectal_cancer
von Wagner C, Baio G, Raine R, Snowball J, Morris S, Atkin W, Obichere A, Handley G, Logan RF, Rainbow S, Smith S, Halloran S, Wardle J. Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol. 2011 Jun;40(3):712-8. doi: 10.1093/ije/dyr008. Epub 2011 Feb 17.
PubMed 21330344Power E, Miles A, von Wagner C, Robb K, Wardle J. Uptake of colorectal cancer screening: system, provider and individual factors and strategies to improve participation. Future Oncol. 2009 Nov;5(9):1371-88. doi: 10.2217/fon.09.134.
PubMed 19903066Huf SW, Asch DA, Volpp KG, Reitz C, Mehta SJ. Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial. J Gen Intern Med. 2021 Jul;36(7):1958-1964. doi: 10.1007/s11606-020-06415-8. Epub 2021 Jan 28.
PubMed 33511567
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Multimodal Approach Using SMS Reminders and an Opt-out Mailed FIT Kits Improve Participation in Colorectal Cancer Screening? A Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03479645
- Acronym / sponsor ID
- 828624
- Conditions
- Bowel Cancer, Colon Cancer
- Keywords
- Colon cancer, Bowel cancer, Cancer screening, text message, Fecal immunochemistry test (FIT), opt-out, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 27 Mar 2018 (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 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary outcome is the rate of FIT kits being returned at 12 weeks.
Detailed description
It is estimated that colorectal cancer (CRC) screening can reduce the risk of dying from bowel cancer by approximately 15%. Yet despite this, the national participation rate is only approximately 62.9%, highlighting that the national target of 70.5% set out in the Healthy People 2020 Objectives remains well out of reach. The US Preventative Task Force (USPSTF) recommends colorectal screening for adults aged 50-75 years through either annual fecal occult blood testing (FOBT), flexible sigmoidoscopy every 5 years or colonoscopy every 10 years. However, many service providers rely on the opportunistic offer of screening at existing health touch-points. This requires the patient to see their healthcare provider, usually for a different clinical reason, the provider to recognize that the patient is overdue for CRC screening and the provider to recommend and book the patient for CRC screening. This process identifies a number of barriers encountered at the system, provider and patient level, to completing a screening test regularly. Furthermore, much evidence indicates that public participation in colorectal screening is heavily influences by socioeconomic factors. Lower participation rates are seen in individuals without health insurance, without a medical home, who are more deprived and from ethnic minority groups. These individuals are more likely to present with later stage disease and experience poorer outcomes. Fecal immunochemistry testing (FIT) is a stool sample based test kit that uses antibodies to detect the human haemoglobin protein in the stool sample and can be completed in the privacy of the home. Research has showed that mailed home test kits such as FOBT or FIT kits can improve CRC participation by reducing the effort required to see a provider in order to arrange CRC screening. Evidence has also shown that text message reminders can improve participation in cancer screening. Furthermore, the message content of text messages can differentially change behavior, for example reducing the 'did not attend rate' in hospital outpatient appointments but also in the context of participation in cervical cancer screening. Therefore this trial will test a multimodal outreach approach, which uses serial SMS reminders with different word contents and mailed FIT kits on the participation rates of CRC screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic. |
| Intervention | Experimental | Behavioral: Serial text messages and mailed FIT kitSerial text messages and mailed FIT kit |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 50-74
- at least 1 clinic visit to the FPCN within the previous 12 months
- due or overdue for colorectal screening
- Asymptomatic for bowel cancer
- mobile phone number available
Key exclusion criteria (13 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) Irritable bowel syndrome does not exclude patients.
- Has 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 |
|---|---|---|
| Serial text messages and mailed FIT kit1. Pre-alert SMS offering Opt-out of mailed FIT kit 2. Mailed home FIT kit 3. SMS A - Reciprocity message 4. SMS B - Offer for second FIT kit if lost/did not receive * Plus SMS A + C if second mailed FIT is requested. 5. SMS C - Salience message | Behavioural | Intervention |
Primary outcome
Colorectal screening rate
Time frame: 12 weeks
The rate patients with who completed colorectal screening within the trial period
9 secondary outcomes
Per Protocol analysis: Colorectal screening rate
Time frame: 12 weeks
FIT kit return rate
Time frame: 12 weeks
Per protocol analysis: FIT kit return rate
Time frame: 12 weeks
colonoscopy completion rate
Time frame: 12 weeks
Per protocol analysis: colonoscopy completion rate
Time frame: 12 weeks
Colorectal screening return rate by gender
Time frame: 12 weeks
FIT return rate by gender
Time frame: 12 weeks
Colorectal screening rate by insurance status
Time frame: 12 weeks
FIT kit return rate by insurance status
Time frame: 12 weeks
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 22 Jul 2019.
- Background: PubMed 8942775Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.
- Background: PubMed 18282806Halpern MT, Ward EM, Pavluck AL, Schrag NM, Bian J, Chen AY. Association of insurance status and ethnicity with cancer stage at diagnosis for 12 cancer sites: a retrospective analysis. Lancet Oncol. 2008 Mar;9(3):222-31. doi: 10.1016/S1470-2045(08)70032-9. Epub 2008 Feb 20.
- Background: PubMed 12230422Clegg LX, Li FP, Hankey BF, Chu K, Edwards BK. Cancer survival among US whites and minorities: a SEER (Surveillance, Epidemiology, and End Results) Program population-based study. Arch Intern Med. 2002 Sep 23;162(17):1985-93. doi: 10.1001/archinte.162.17.1985.
- BackgroundInstitute NC. Caner trends progress reprot; Colorectal Screening. https://progressreport.cancer.gov/detection/colorectal_cancer
- Background: PubMed 21330344von Wagner C, Baio G, Raine R, Snowball J, Morris S, Atkin W, Obichere A, Handley G, Logan RF, Rainbow S, Smith S, Halloran S, Wardle J. Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol. 2011 Jun;40(3):712-8. doi: 10.1093/ije/dyr008. Epub 2011 Feb 17.
- Background: PubMed 19903066Power E, Miles A, von Wagner C, Robb K, Wardle J. Uptake of colorectal cancer screening: system, provider and individual factors and strategies to improve participation. Future Oncol. 2009 Nov;5(9):1371-88. doi: 10.2217/fon.09.134.
- Derived from this study: PubMed 33511567Huf SW, Asch DA, Volpp KG, Reitz C, Mehta SJ. Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial. J Gen Intern Med. 2021 Jul;36(7):1958-1964. doi: 10.1007/s11606-020-06415-8. Epub 2021 Jan 28.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial text messages and mailed FIT kit in people with Bowel Cancer and Colon Cancer, 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 13 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 22 Jul 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?
Colorectal screening rate (time frame: 12 weeks). 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 NCT03479645, which also lists 7 linked publications.
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 22 Jul 2019.