Colorectal CancerNCT03487523
Health Message Framing to Improve Uptake of Bowel Cancer Screening
A study testing Text Message in people with Colorectal Cancer, run by National Heatlh Service Ayrshire and Arran.
Trial summary
The objective of this research is to investigate whether a text message (SMS message) prompting participation in the UK national bowel cancer screening programme improves uptake for those who have not responded to the test. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Text Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2018to 31 Jan 2019
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 55
- Not yet returned a bowel cancer screening sample
- No diagnosis of bowel cancer
Who cannot join
- Under 55
- Have already completed bowel cancer screening
- Diagnosed with bowel cancer
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this research is to investigate whether a text message (SMS message) prompting participation in the UK national bowel cancer screening programme improves uptake for those who have not responded to the test.
The secondary objective is to investigate whether the framing/phrasing of the text message improves participation , whether by stating the benefits of uptake or alternatively by stating the costs of non-uptake.
Read the detailed description
A national register exists for GP practices to identify which patients of theirs have or have not participated in a national bowel cancer screening programme. A sample of 1600 patients belonging to a particular practice in Scotland aged between 50 and 74 have been identified as having received the test kit but have not responded to it. These individuals have also previously consented to being contacted by the practice via phone text/SMS message for reminders.
The sample will be randomised into three equally populated groups:
- One group will act as the control arm and will receive no text message.
- One group will receive a text message which encourages participation in the screening programme and provides information on the cost of not participating (negative frame) - "If you do not take part in screening then you increase the risk of having an undiagnosed tumor."
- One group will receive a text message which encourages participation in the screening programme and provides information on the benefit of participating (positive frame) - "If you take part in screening then you decrease the risk of having an undiagnosed tumor."
Both text messages will include a weblink which will direct individuals receiving the text to find more information and also with instructions on how to order another kit should they have misplaced the kit that was mailed out to them.
The observation period will last 6 months and patients receiving the text will receive 3 texts in total. One at the start of the 6 months and another every two months after that. These messages will not change or alternate, that is the negatively framed group will receive the same text once every 2 months on 3 occasions in total and vice versa. Other studies have used shorter intervals between text messages to encourage change, although 6 months to 1 year is a standard amount of time overall. The researchers feel that while more regular messages may be more likely prompt behaviour there is also a risk of over-burdening the patient with reminders, as such 3 texts over 6 months was decided upon as a reasonable frequency.
At the end of the 6 months data on uptake of screening for those 1600 patients during that time will be extracted by the practice clinician, matched with patient characteristics (e,g, age, sex) and anonymised so that patients cannot be identified. This will then be sent to the health economist to analyse the data and test the hypotheses above. Regression analysis will be used to see whether a differential pattern of uptake exists between groups receiving and not receiving the text message.
Once analysed the results will be fed back to the practice in order to help inform future reminders and will also be drafted into a paper to be submitted for peer-review.
- Conditions
- Colorectal Cancer
- Being tested
- Text Message
- Keywords
- Behavioural Economics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageBehavioural
As already stated
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Active comparator | Text message (SMS Message) Receives: Behavioral: Text Message |
| Intervention 2 | Active comparator | Text message (SMS Message) Receives: Behavioral: Text Message |
| Intervention 3 | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants taking part in the Scottish national bowel cancer screening programme
Number of participants taking part in the Scottish national bowel cancer screening programme represented as a patient having submitted a faecal occult blood test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start21 Jun 2018 (estimated)
- Primary completion21 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be a cross sectional randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heatlh Service Ayrshire and Arran
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Patrick McGuire, National Heatlh Service Ayrshire and Arran
- Investigators
- Patrick McGuire, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487523
- Sponsor's protocol ID
- 224710
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Message Framing to Improve Uptake of Bowel Cancer Screening
- ClinicalTrials.gov ID
- NCT03487523
- Acronym / sponsor ID
- 224710
- Conditions
- Colorectal Cancer
- Keywords
- Behavioural Economics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- National Heatlh Service Ayrshire and ArranOther government
- Study start
- 21 Jun 2018 (estimated)
- Primary completion
- 21 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 4 Apr 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.
The objective of this research is to investigate whether a text message (SMS message) prompting participation in the UK national bowel cancer screening programme improves uptake for those who have not responded to the test.
The secondary objective is to investigate whether the framing/phrasing of the text message improves participation , whether by stating the benefits of uptake or alternatively by stating the costs of non-uptake.
Detailed description
A national register exists for GP practices to identify which patients of theirs have or have not participated in a national bowel cancer screening programme. A sample of 1600 patients belonging to a particular practice in Scotland aged between 50 and 74 have been identified as having received the test kit but have not responded to it. These individuals have also previously consented to being contacted by the practice via phone text/SMS message for reminders.
The sample will be randomised into three equally populated groups:
- One group will act as the control arm and will receive no text message.
- One group will receive a text message which encourages participation in the screening programme and provides information on the cost of not participating (negative frame) - "If you do not take part in screening then you increase the risk of having an undiagnosed tumor."
- One group will receive a text message which encourages participation in the screening programme and provides information on the benefit of participating (positive frame) - "If you take part in screening then you decrease the risk of having an undiagnosed tumor."
Both text messages will include a weblink which will direct individuals receiving the text to find more information and also with instructions on how to order another kit should they have misplaced the kit that was mailed out to them.
The observation period will last 6 months and patients receiving the text will receive 3 texts in total. One at the start of the 6 months and another every two months after that. These messages will not change or alternate, that is the negatively framed group will receive the same text once every 2 months on 3 occasions in total and vice versa. Other studies have used shorter intervals between text messages to encourage change, although 6 months to 1 year is a standard amount of time overall. The researchers feel that while more regular messages may be more likely prompt behaviour there is also a risk of over-burdening the patient with reminders, as such 3 texts over 6 months was decided upon as a reasonable frequency.
At the end of the 6 months data on uptake of screening for those 1600 patients during that time will be extracted by the practice clinician, matched with patient characteristics (e,g, age, sex) and anonymised so that patients cannot be identified. This will then be sent to the health economist to analyse the data and test the hypotheses above. Regression analysis will be used to see whether a differential pattern of uptake exists between groups receiving and not receiving the text message.
Once analysed the results will be fed back to the practice in order to help inform future reminders and will also be drafted into a paper to be submitted for peer-review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study will be a cross sectional randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Active comparator | Behavioral: Text MessageText message (SMS Message) |
| Intervention 2 | Active comparator | Behavioral: Text MessageText message (SMS Message) |
| Intervention 3 | No intervention | –no intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 55
- Not yet returned a bowel cancer screening sample
- No diagnosis of bowel cancer
Key exclusion criteria (3 listed)
- Under 55
- Have already completed bowel cancer screening
- Diagnosed with bowel cancer
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 MessageAs already stated | Behavioural | Intervention 1, Intervention 2 |
Primary outcome
Number of participants taking part in the Scottish national bowel cancer screening programme
Time frame: 6 months
Number of participants taking part in the Scottish national bowel cancer screening programme represented as a patient having submitted a faecal occult blood test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- 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.
Patrick McGuire principal investigator
Dr
Questions about this trial
What is this clinical trial studying?
A study testing Text Message in people with Colorectal Cancer, run by National Heatlh Service Ayrshire and Arran.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick McGuire (+447596096536, paddymcguire7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants taking part in the Scottish national bowel cancer screening programme (time frame: 6 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 4 Apr 2018.