Colorectal CancerNCT03642652
SMS Reminders for Positive FOBT Follow-up
A study testing SMS in people with Colorectal Cancer, run by Meuhedet. Healthcare Organization.
Trial summary
A randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among Meuhedet members aged 50-74 who tested positive in 2016. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 May 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 75 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive fecal occult blood test (FOBT) in 2016
- agreed to receive SMS from healthcare provider
Who cannot join
- Existing oncology diagnosis
- personal or family history of colorectal cancer
- colonoscopy up to 10 years prior to FOBT
About this study
Official title: Repeated Automated Mobile Text Reminders for Follow-up of Positive Fecal Occult Blood Tests: a Randomized Controlled Trial
A randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among Meuhedet members aged 50-74 who tested positive in 2016.
Read the detailed description
Background: Fecal occult blood tests are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer, but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation.
Objective: To examine the effectiveness of a short message service in increasing adherence to colonoscopy follow-up after a positive fecal occult blood test.
Methods: This randomized controlled trial was conducted with patients who had positive colorectal cancer screening results. Randomization was stratified by residential district and socioeconomic status. Subjects in the control group (n = 238) received routine care that included an alert to the physician regarding the positive Fecal occult blood test result. The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their computerized medical records. Physicians of the study patients completed an attitude survey regarding FOBT as a screening test for colorectal cancer. The intervention and control groups were compared using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios and 95% confidence intervals for performing colonoscopy within 120 days, adjusting for potential confounders of age, gender, socioeconomic status, district, ethnicity, intervention group and physician's attitude.
- Conditions
- Colorectal Cancer
- Being tested
- SMS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMSBehavioural
Also called mobile text reminder
Text reminders to mobile telephone
| Study group | Role | What they receive |
|---|---|---|
| SMS | Experimental | Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the findings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." Receives: Behavioral: SMS |
| Control | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up colonoscopy 120 days after a positive fecal occult blood test
Completion of colonoscopy
Measured: 120 days after positive FOBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion1 May 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 Colorectal CancerStudies of the same condition, open and under way.
- 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
- Model description
- Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meuhedet. Healthcare Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642652
- Sponsor's protocol ID
- 01-023-03-16
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Repeated Automated Mobile Text Messaging Reminders for Follow-Up of Positive Fecal Occult Blood Tests: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 5;7(2):e11114. doi: 10.2196/11114.
PubMed 30720439
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Automated Mobile Text Reminders for Follow-up of Positive Fecal Occult Blood Tests: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03642652
- Acronym / sponsor ID
- 01-023-03-16
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Meuhedet. Healthcare OrganizationUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 22 Aug 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.
A randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among Meuhedet members aged 50-74 who tested positive in 2016.
Detailed description
Background: Fecal occult blood tests are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer, but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation.
Objective: To examine the effectiveness of a short message service in increasing adherence to colonoscopy follow-up after a positive fecal occult blood test.
Methods: This randomized controlled trial was conducted with patients who had positive colorectal cancer screening results. Randomization was stratified by residential district and socioeconomic status. Subjects in the control group (n = 238) received routine care that included an alert to the physician regarding the positive Fecal occult blood test result. The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their computerized medical records. Physicians of the study patients completed an attitude survey regarding FOBT as a screening test for colorectal cancer. The intervention and control groups were compared using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios and 95% confidence intervals for performing colonoscopy within 120 days, adjusting for potential confounders of age, gender, socioeconomic status, district, ethnicity, intervention group and physician's attitude.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
| Arm | Type | Receives |
|---|---|---|
| SMS | Experimental | Behavioral: SMSEach patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the findings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." |
| Control | No intervention | –Routine care |
Who may qualify
- Ages
- 50 to 75 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- positive fecal occult blood test (FOBT) in 2016
- agreed to receive SMS from healthcare provider
Key exclusion criteria (3 listed)
- Existing oncology diagnosis
- personal or family history of colorectal cancer
- colonoscopy up to 10 years prior to FOBT
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 |
|---|---|---|
| SMSAlso: mobile text reminderText reminders to mobile telephone | Behavioural | SMS |
Primary outcome
Follow-up colonoscopy 120 days after a positive fecal occult blood test
Time frame: 120 days after positive FOBT
Completion of colonoscopy
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 24 Aug 2018.
- Derived from this study: PubMed 30720439Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Repeated Automated Mobile Text Messaging Reminders for Follow-Up of Positive Fecal Occult Blood Tests: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 5;7(2):e11114. doi: 10.2196/11114.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SMS in people with Colorectal Cancer, run by Meuhedet. Healthcare Organization.
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 2 inclusion and 3 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 24 Aug 2018. 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?
Follow-up colonoscopy 120 days after a positive fecal occult blood test (time frame: 120 days after positive FOBT). 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 NCT03642652, 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 24 Aug 2018.