Breast ScreeningNCT01977599
Are Text Message Reminders an Effective Intervention for Improving the Uptake of Breast Screening?
A study testing Text Message Reminder for Breast Screening Appointment in people with Breast Screening, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early stages of development, during which time it is more easily treatable. Read more about this study
- Who is it for?
- Ages 47 to 53 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Screening
- What is being tested?
- Text Message Reminder for Breast Screening Appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 47 to 53 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 47-53 years, being invited for their first breast screen, without a history of breast disease or malignancy, living in the London Borough of Hillingdon, were eligible for inclusion in the trial.
Who cannot join
- Women with a history of breast disease, malignancy, bi-lateral mastectomy, or breast screen, aged over 54 years were not eligible for inclusion in the trial. Non-routine appointments, male appointments, and self referrals were also not eligible for inclusion.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charing Cross Hospital
Hammersmith, London, W6 8RF
About this study
Official title: A Randomised Controlled Trial Investigating the Efficacy and Effectiveness of Text Message Reminders to Improve Uptake of Breast Screening by Prevalent Women Living in the London Borough of Hillingdon
Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early stages of development, during which time it is more easily treatable. Unfortunately, many patients do not attend screening, and surveys issued to these women consistently report "forgetfulness" as the primary reason for missing the appointment. Both telephone reminders and postal reminders have been shown to reduce non-attendance, however, these are time consuming and expensive.
Mobile telephones are becoming an increasingly popular tool for communication between healthcare professionals and patients, one which might offer an inexpensive solution for delivering reminders. Text message reminders have been able to prevent missed appointments in other areas of healthcare, and the same might be true for breast screening.
Read more
The investigators are conducting a trial to confirm whether this is the case or not.
In this trial, the investigators will send some women a text message to reminder them of their appointment, and other women no reminder for their appointment. The investigators will then compare the number of women in each group that went to their breast screening appointment.
Read the detailed description
Breast cancer is the single most common cancer in the United Kingdom, accounting for 16% of all cancer incidences and 7% of all cancer deaths. Fortunately, the natural progression of this malignancy can be beneficially changed through mammographic screening techniques, which enable early detection and treatment of benign and malignant breast disease. However, the success of screening programmes depends not only on the analytical specificity and sensitivity of the screening test itself, but also its ability to attract the "at risk" population. In the United Kingdom, the National Health Service Breast Screening Programme attracts about three quarters of the invited population every three years. In the last screening round (2007-2010), all but one region reported a triennial coverage of more than 75%; London was the exception, reporting a regional coverage of 69%. London consistently fails to meet the national target.
Missed appointments are a primary cause of inefficiency in healthcare delivery, with adverse clinical implications for the non-attending patient, and substantial monetary costs to the health service. To ensure the future success of the breast screening programme it is imperative that strategies for improving uptake of hard to reach populations be developed. Research has demonstrated that receiving an appointment reminder by text message has been successful in improving uptake in other areas of healthcare; the same might be true for breast screening.
Primary Aim: To establish whether text message reminders can significantly improve the uptake of breast screening by women on an "intention-to-treat" basis in the London Borough of Hillingdon.
Secondary Aim: To evaluate whether text message reminders are an effective intervention for improving uptake of the breast screening programme by hard to reach patients such as women living in deprived areas, and those of Black and Minority ethnic backgrounds.
Methodology: A single blind randomised controlled trial evaluating the effectiveness, efficacy, and acceptability of sending a text message appointment reminder to prevalent women (women aged 47-53 years) living in the London Borough of Hillingdon 48 hours prior to their first breast screening appointment. 2,239 women without a history of breast screening, implant, or bilateral mastectomy were included in the study and randomly assigned in a 1:1 ratio to either the control group (n= 1,118) or the intervention group (n= 1,121). Women in the control group were invited to screening but received no reminder for their appointment, whilst women in the intervention group received a text message reminder 48 hours in advance. All women received an information letter about the study with their invitation from the West of London Breast Screening Service, which included a patient "opt-out" request form. Patients were not told whether they would be receiving a text message reminder or not. iPlato Patient Care Messaging was used to deliver the text-message reminders.
- Conditions
- Breast Screening
- Being tested
- Text Message Reminder for Breast Screening Appointment
- Keywords
- Text message reminders, Short Message Service (SMS) Reminders, Social Health Inequalities, Breast Screening, Screening, Public Health Intervention, Missed Appointments, Non-attendance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message Reminder for Breast Screening AppointmentOther
Also called iPlato Patient Care Messaging will be used to send the text message reminder to the patient.
Non-clinical/administrative.
| Study group | Role | What they receive |
|---|---|---|
| No Text Message Reminder (Control) Arm | No intervention | Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences. |
| Text Message Reminder Arm | Experimental | Patients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance. Receives: Other: Text Message Reminder for Breast Screening Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at Breast Screening
Number of women that participate in breast screening in the control (no text message reminder) compared with the number of women that participate in the intervention (text message reminder 48 hours before appointment).
Measured: The text message was sent 48 hours before the appointment, attendance was assessed 60 days after the appointment date.
Secondary outcomes (1)
Mobile Prevalence
Number of women with a valid mobile telephone number on the GP Clinical System
Measured: The accuracy of patient mobile records was assessed for the intervention group at the time the text reminder was sent (i.e. 48 hours before the appointment). A check for the control group was performed at the same time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast ScreeningStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellis Friedman, FFPH, Study chair, London Borough of SuttonHeema Shukla, PhD, Study chair, Public Health EnglandDeborah Cunningham, MBBS, Study chair, Imperial College Healthcare NHS TrustRobert S Kerrison, BSc, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977599
- Sponsor's protocol ID
- 7114/P21R
- Other IDs
- 12/EM/0418
- Status last verified
- Mar 2021
- First submitted
- 9 Oct 2013
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating the Efficacy and Effectiveness of Text Message Reminders to Improve Uptake of Breast Screening by Prevalent Women Living in the London Borough of Hillingdon
- ClinicalTrials.gov ID
- NCT01977599
- Acronym / sponsor ID
- 7114/P21R
- Conditions
- Breast Screening
- Keywords
- Text message reminders, Short Message Service (SMS) Reminders, Social Health Inequalities, Breast Screening, Screening, Public Health Intervention, Missed Appointments, Non-attendance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,240 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early stages of development, during which time it is more easily treatable. Unfortunately, many patients do not attend screening, and surveys issued to these women consistently report "forgetfulness" as the primary reason for missing the appointment. Both telephone reminders and postal reminders have been shown to reduce non-attendance, however, these are time consuming and expensive.
Mobile telephones are becoming an increasingly popular tool for communication between healthcare professionals and patients, one which might offer an inexpensive solution for delivering reminders. Text message reminders have been able to prevent missed appointments in other areas of healthcare, and the same might be true for breast screening.
The investigators are conducting a trial to confirm whether this is the case or not.
In this trial, the investigators will send some women a text message to reminder them of their appointment, and other women no reminder for their appointment. The investigators will then compare the number of women in each group that went to their breast screening appointment.
Detailed description
Breast cancer is the single most common cancer in the United Kingdom, accounting for 16% of all cancer incidences and 7% of all cancer deaths. Fortunately, the natural progression of this malignancy can be beneficially changed through mammographic screening techniques, which enable early detection and treatment of benign and malignant breast disease. However, the success of screening programmes depends not only on the analytical specificity and sensitivity of the screening test itself, but also its ability to attract the "at risk" population. In the United Kingdom, the National Health Service Breast Screening Programme attracts about three quarters of the invited population every three years. In the last screening round (2007-2010), all but one region reported a triennial coverage of more than 75%; London was the exception, reporting a regional coverage of 69%. London consistently fails to meet the national target.
Missed appointments are a primary cause of inefficiency in healthcare delivery, with adverse clinical implications for the non-attending patient, and substantial monetary costs to the health service. To ensure the future success of the breast screening programme it is imperative that strategies for improving uptake of hard to reach populations be developed. Research has demonstrated that receiving an appointment reminder by text message has been successful in improving uptake in other areas of healthcare; the same might be true for breast screening.
Primary Aim: To establish whether text message reminders can significantly improve the uptake of breast screening by women on an "intention-to-treat" basis in the London Borough of Hillingdon.
Secondary Aim: To evaluate whether text message reminders are an effective intervention for improving uptake of the breast screening programme by hard to reach patients such as women living in deprived areas, and those of Black and Minority ethnic backgrounds.
Methodology: A single blind randomised controlled trial evaluating the effectiveness, efficacy, and acceptability of sending a text message appointment reminder to prevalent women (women aged 47-53 years) living in the London Borough of Hillingdon 48 hours prior to their first breast screening appointment. 2,239 women without a history of breast screening, implant, or bilateral mastectomy were included in the study and randomly assigned in a 1:1 ratio to either the control group (n= 1,118) or the intervention group (n= 1,121). Women in the control group were invited to screening but received no reminder for their appointment, whilst women in the intervention group received a text message reminder 48 hours in advance. All women received an information letter about the study with their invitation from the West of London Breast Screening Service, which included a patient "opt-out" request form. Patients were not told whether they would be receiving a text message reminder or not. iPlato Patient Care Messaging was used to deliver the text-message reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Text Message Reminder (Control) Arm | No intervention | –Control Arm, in which patients are invited to breast screening as per standard West of London Breast Screening Protocol (i.e. without a text message appointment reminder). Uptake of breast screening in this group will be compared with the text message reminder group to test for significant differences. |
| Text Message Reminder Arm | Experimental | Other: Text Message Reminder for Breast Screening AppointmentPatients randomly allocated to this arm of the study will be sent a text message reminding them of the time, date and venue of their breast screening appointment 48 hours in advance. |
Who may qualify
- Ages
- 47 to 53 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 47-53 years, being invited for their first breast screen, without a history of breast disease or malignancy, living in the London Borough of Hillingdon, were eligible for inclusion in the trial.
Key exclusion criteria (1 listed)
- Women with a history of breast disease, malignancy, bi-lateral mastectomy, or breast screen, aged over 54 years were not eligible for inclusion in the trial. Non-routine appointments, male appointments, and self referrals were also not eligible for inclusion.
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 Message Reminder for Breast Screening AppointmentAlso: iPlato Patient Care Messaging will be used to send the text message reminder to the patient.Non-clinical/administrative. | Other | Text Message Reminder Arm |
Primary outcome
Attendance at Breast Screening
Time frame: The text message was sent 48 hours before the appointment, attendance was assessed 60 days after the appointment date.
Number of women that participate in breast screening in the control (no text message reminder) compared with the number of women that participate in the intervention (text message reminder 48 hours before appointment).
1 secondary outcome
Mobile Prevalence
Time frame: The accuracy of patient mobile records was assessed for the intervention group at the time the text reminder was sent (i.e. 48 hours before the appointment). A check for the control group was performed at the same time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellis Friedman, FFPH study chair
London Borough of Sutton
Heema Shukla, PhD study chair
Public Health England
Deborah Cunningham, MBBS study chair
Imperial College Healthcare NHS Trust
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 Message Reminder for Breast Screening Appointment in people with Breast Screening, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 6 Apr 2021. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Attendance at Breast Screening (time frame: The text message was sent 48 hours before the appointment, attendance was assessed 60 days after the appointment date.). 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 6 Apr 2021.