Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

No intervention, group 24-29 years. Women will receive the written invitation to screening only

Messenger text message reminder, group 24-29 years.

No intervention group 30-64 years, Women will receive the written invitation to screening only

Messenger text message reminder, group 30-64

Social Norms (population proportion) text message reminder, group 30-64 years

Social Norms (population total) text message reminder, group 30-64 years

Framed gain text message reminder, group 30-64 years

Framed loss text message reminder, group 30-64 years

"Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Neutral text message reminder

"\<GP NAME\>: Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Messenger text message reminder

"Last year in Hillingdon 7 out of 10 women took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Social Norms A reminder

"Last year 12000 women in Hillingdon took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Social Norms B reminder

"Cervical cancer screening saves 4500 lives in England every year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Framed Gain text reminder

"Failing to attend cervical screening could lead to 4500 avoidable deaths in England each year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Framed Loss text reminder

Deborah Cunningham

Cervical cancer is the most common cancer in women under 35 years and is a major public health concern. Fortunately, the natural history of this malignancy can be beneficially improved through cytological screening. However, the success of screening programmes depends on their ability to attract the "at risk" population, as well as the analytical sensitivity and specificity of the screening test. In the UK, screening consistently falls short of the 80% national target and recent evidence shows uptake is decreasing, in part due to the introduction of HPV vaccination programmes. In the under 30s London population, average coverage only reached 50% in 2013. Given this information, the cervical screening programme is under increasing pressure to improve uptake, and need an evidence based intervention.

We aim to improve the uptake of cervical screening using SMS messaging through a randomised controlled trial. The trail will evaluate both the prevalent and incident rounds of screening and within the intervention group, analyse how the content of text reminders influences their effectiveness. Specifically we will evaluate a) neutral b) messenger c) social norms d) framed gain/loss reminders. Unlike our previous trial, this SMS reminder will encourage the booking of an appointment which has never been tested, rather than simply reminding women to attend. All women being invited for cervical screening, registered at participating GPs within Hillingdon will be eligible to participate. Women will also be provided with a 2 week window during which they can opt out of the research. Given the sample sizes we predict the trial will take 9 months.

In Hillingdon specifically, where this randomised controlled trial (RCT) will be set, the uptake of the prevalent population of women (24-29 years as a proxy), was only 35% in 2012, whilst the incident population (30-64years as a proxy) was slightly higher at 51% (HSCIC2, 2013).

One strategy which healthcare has previously employed to improve uptake of both screening and routine appointments is the use of SMS or "text message" reminders. Standard reminders have often been used in healthcare and act as "primers", prompting people to make healthier choices (Blumenthal-Barby \& Burroughs, 2012). They also serve to reduce the practical barriers preventing women from attending i.e. failure to book or remember the time/location of the appointment. Previous research investigating the effectiveness of appointment reminders demonstrated that both telephone and postal reminders, although at times effective, were often impractical, unsustainable, and/or unaffordable (Gurol-Urganci et al, 2013, Perron et al, 2013).

SMS interventions have been effective at improving medication adherence, disease management and smoking cessation (Krishna et al, 2013; Abroms et al, 2014). They have also proven effective at reducing "Do Not Attends" (DNAs) within healthcare, estimated to cost the NHS £600 million per year in wasted time and resources (Dr Foster Research, 2009). SMS reminders were also found to be very successful at increasing the attendance of breast screening appointments, increasing the uptake by 17% compared to usual care (Kerrison et al, 2013). As well as improving attendance, SMS reminders have also proved effective at reducing costs, increasing the efficiency of clinics, enabling more effective booking, reducing mismatches between demand and capacity, and generally helping to increase productivity within healthcare.

SMS interventions have many benefits over alternative mediums. Firstly an SMS is cheap, roughly 3p per text whilst a letter can cost 10 times that. SMS is also capable of reaching the recipient wherever they are whilst letters can only be delivered to recipients last known address. This is particularly important, as people are more likely to retain their mobile numbers nowadays even if they change address, especially in London where the population is notoriously mobile. Mobile phone use is also ubiquitous in the UK, with a recent report estimating that over 99% of adults in London owned a mobile phone in 2013 (Ofcom, 2013). Another advantage of SMS is that there is evidence that people increasingly use electronic day planners and therefore a message direct to a person's phone encourages people to promptly record appointments and even allowing them to set alarms creating their own reminder. SMS interventions would therefore be as wide reaching as a postal intervention (if not more so) at a fraction of the cost and with greater accuracy.

Although previous evidence provides a sound rationale that SMS interventions have great potential for cervical screening, there is still a considerable amount of information required in order to introduce this intervention as standard practice.

The research also aims to evaluate whether minor differences in wording affect women's response to these messages. This idea stems from "Nudge" theory, a form of Libertarian Paternalism or "Asymmetric Paternalism" (Thaler and Sunstein, 2003). This concept is derived from a mix of cognitive psychology and behavioural science which is based on the principal that humans, due to a lack of information, experience, cognitive ability and self-control, often fail to act in a way that promotes their own welfare (Sunstein and Thaler, 2003). Libertarian paternalisms therefore encourages individuals to act in their, and/or societies, best interests whilst maintaining freedom of choice (Aggarwal et al 2014). Although the use of "nudge" has been viewed as controversial within healthcare by some, this study has justified its use by avoiding any form of coercion, and making it clear that this text is simply a reminder of the normal invitation process.

There is mounting evidence demonstrating that even small changes in the content and framing heavily influences people decisions (Haynes et al, 2013; Hallsworth et al, 2014). Whether the positive effects of small wording changes or "nudging" is reflected in women's attitudes towards cervical screening programs has yet to be evaluated. This information will be crucial in order to maximise efficiency of this intervention and knowledge gained could be applied to similar interventions in healthcare making them more cost effective. We also hope to evaluate whether people with different levels of deprivation respond differently to the different messages. This is hugely important, as tailoring the message to the population is crucial to improving the efficiency of the intervention and to reduce health inequalities within London.

In light of this evidence we have chosen seven different text message options, all of which have according to research great potential to improve the uptake of screening. These include a control of no text message, a neutral reminder and five reminders with behavioural messages to prompt uptake. The intervention arms according to research have great potential to improve the uptake of screening. It is well established that reducing the effort required to perform an action increases the likelihood of follow-through (Leventhal et al, 1965).

All text messages begin with the test message, followed by a standard reminder message that is constant across the messages and the participants GP practice phone number.

The chosen messages are no text message, a neutral message; a messenger; two social norms; a gain frame and a loss frame highlighting the benefits of cervical screening.

Neutral Reminder

The neutral message will not "nudge" but simply remind the woman to book a cervical screening appointment, acting as a direct reminder of the letter invitation sent out as normal practice. It will act as a control for the other types of message.

"Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Messenger Reminder

Some evidence suggests that people respond better to invitations from their personal practice rather than a centralised NHS organisation (Segan et al, 1998; Arbyn et al, 2010). This is especially true of young women, immigrants, urban residents and those with low socioeconomic status, which are key demographics we hope to improve uptake in through this intervention (Bosgraaf et al, 2013).

"\<GP NAME\>: Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Social Norms Messages

Social norms messages focus on the principal that people have a tendency to overestimate the extent to which their peers perform acts, causing themselves or others harm. Evidence suggests educating people about the actual degree to which people perform these acts can alter behaviour (Perkins et al, 2002). This theory, combined with the fact that people are strongly influenced by comparison to what others do will hopefully prompt women to take up the offer of cervical screening. We have also chosen to use a local statistics as personalised messages have a greater influence as they increase the relevance of the message to the women (Institute for government: Cabinet Office, 2010)

1. Social Norms (local, proportion) reminder:

   "Last year in Hillingdon 7 out of 10 women took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"
2. Social Norms (local, total number) reminder:

"Last year 12000 women in Hillingdon took part in cervical screening. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

Gain and Loss Frame Messages

The role gain and loss frame messengers to encourage uptake of good health behaviour is not entirely clear. Some evidence points to humans having "have a stronger aversion to losses than we do affinity to gains" therefore highlighting losses may have a greater impact (Blumenthal-Barby \& Burroughs, 2012). On the other hand a meta-analysis found that gain frame was more likely to be effective in changing prevention behaviour. (Gallagher, 2001). To evaluate this further a gain and loss frame message were included above. Statistics included in these messages were taken from (Peto, 2004) and correlate to widely used statistics on cancerscreening.nhs.uk to maintain consistency with other information women might be seeing.

1. Gain frame

   "Cervical cancer screening saves 4500 lives in England every year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"
2. Loss frame

"Failing to attend cervical screening could lead to 4500 avoidable deaths in England each year. Your cervical smear test is due. To book please call \<xxxxxxxxxxx\>"

POTENTIAL ETHICAL ISSUES

The main ethical issue is that in order to analyse the data, the researcher will need to access minimal amounts of patient data. The researcher will specifically need to access a list of women in Hillingdon who are sent an invitation to cervical screening on a weekly basis, if they are registered with a consenting GP. All participating GPs (which to date include over 85% of those approached for the trial) have consented to share relevant data with the research team and are happy with the safeguards put in place to protect confidentiality. These include NHS secure emails, password protection on all patient data, anonymisation of data (identifiable by NHS number only) and strict adherence to all NHS information governance regulations.

On this list, each participant will be identified by their NHS number, and this will be the only unique identifier. The researcher will also need information about their age (not date of birth), participants "attended/not attended status" at the end of the 18 week follow up period and the GP practice code, to ensure we only include women registered with consenting GPs. We would also like to access the second half of participants' postcode to allow for a basic deprivation analysis.

Before accessing this information we will offer women the option to opt out of the research and therefore not share this data or receive a text message reminder. This will be achieved by the cervical screening (call-recall) team adding an insert on behalf of the GP, into the screening invitation letter to all eligible women. This insert will provide informed consent slip and contact details of the researcher if women would like further information. They will have 2 weeks to respond and be removed from the study.

As an extension of this research, the trial will also investigate how variations in the wording of the text messages affect uptake. This wording has been carefully selected with the guidance of the NHS Cervical Screening Program (NHSCSP) as well as Public Health England psychology experts and any data within the text messages is up to date and sourced from the NHSCS.

Can Text Reminders Improve Uptake of Cervical Screening?

Can Text Reminders Improve Uptake of Cervical Screening? A RCT.

Analysis of the rate of cervical screening by trial arm at the end of the screening round (32 weeks)

Attendance within different groups by trial arm

Attendance within groups of different levels of deprivation (using IMD) by trial arm

Analysis of the rate of cervical screening by trial arm using SMS delivery status data to compared the rate of cervical screening in women who receive the SMS at the end of the screening round (32 weeks from screening invitation)

Sarah Huf

Clinical Research Fellow

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types

A targeted, stepped and low information burden invitation strategy and materials, specifically designed to improve uptake by reducing barriers to participation among smokers from socioeconomically deprived backgrounds.

In the absence of usual care screening invitation materials, the control invitation materials and strategy are based upon the best available materials and methods of existing cancer screening programmes. These are comprised of the following:

1. a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes
2. an invitation letter with a pre-scheduled appointment plus the same information booklet
3. a reminder re-invitation letter for those who miss their appointment without cancelling

Control invitation materials

The intervention invitation strategy is comprised of the same stages of invitation materials as the control group. The two differences are i) Instead of the information booklet they will received a targeted leaflet, and ii) the invitation and reminder letters will use indirect phrasing to explain that smokers and ex-smokers are being invited. Together, these manipulations aim to deliver a targeted, stepped and low burden approach to information provision prior to the appointment.

Intervention invitation materials

Samuel Janes

This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a "lung health check" and be invited to a baseline screening scan if eligibility criteria are fulfilled.

Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented.

In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a "lung health check appointment" via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds.

Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes.

Lung Screen Uptake Trial

Randomised Controlled Trial to Test Novel Invitation Methods and Materials Targeted to Increase Informed Uptake of Lung Cancer Screening in Individuals at High Risk of Lung Cancer

This will be collected at enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).

Invitation to participation in the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study).

Demographics of those invited to the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study).

This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).

This data will be recorded at multiple timepoints following enrolment of the participant to the study. This will therefore occur from from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).

University College London Hospitals

Homerton University Hospital NHS Foundation Trust

University College, London

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Behaviorally enhanced reminder letter plus test kit

Behavioral interventions to increase FIT-based colorectal cancer screening uptake

Behaviorally enhanced reminder letter

Nicholas Clarke, PhD

High uptake is vital to population-based screening. BowelScreen (Irelands national organised population-based colorectal cancer screening programme) has not achieved recommended screening uptake targets. In Ireland sending the test kit in the screening invitation reminder may be an important strategy in targeting non-responders and would address a key difference between Ireland and other international screening programmes with higher uptake. In addition, few studies have focused on behavioural barriers to screening participation. Founded upon the MRC Guidelines for the Development of Complex Interventions, our systematic, theoretically-informed investigation of FIT screening participation has begun to identify behavioural antecedents to screening participation in Ireland. This study will implement a multilevel evidence-based, theoretically-informed intervention which includes the automatic inclusion of the test kit in the screening reminder, alone and in combination with an intervention to influence individuals' screening participation. This multilevel intervention will provide recommendations for the screening invitation delivery, potentially bringing the programme closer to recommended uptake targets (50%) and in the long-term influence reductions in bowel cancer incidence and mortality in Ireland.

To achieve population-level health gains, colorectal cancer screening programmes require high uptake. Guidelines recommend uptake of 65%-75%. In Ireland, faecal immunochemical test (FIT)-based screening uptake is considerably lower than this (around 40%), despite FIT being recommended as the screening test of choice given its potential to deliver higher uptake than other tests. As well as being suboptimal overall, uptake in Ireland is significantly lower among males and lower socioeconomic groups the very groups at higher underlying risk of colorectal cancer. While improving overall uptake is important, focus is also needed on reducing differentials in uptake; left unchecked these may lead to further disparities in health outcomes among those most at risk.

The main difference between Ireland's screening programme and programmes with higher uptake is that BowelScreen does not send the test kit with the screening invitation: invitees are required to contact a call-centre, consent to participate and request the kit. Uptake in Ireland is 10-30% lower than Scotland, the Netherlands and England and, indeed, in a pilot screening programme in Dublin that also sent the test automatically.

Internationally, various strategies to improve uptake have been tested. Some studies report increases using advance notification letters, postal mailing of home-based testing kits, and telephone contacts but many studies have been negative. Recent UK research points to potential in intervening among non-responders to the initial screening invitation, but few intervention studies have focussed on non-responders. An important limitation of existing studies is that most investigators failed to base their interventions on an understanding of what influences individuals' decisions about screening participation/non-participation.

A range of barriers to uptake have been identified and include fatalism, poor knowledge, being poorly informed about cancer and screening and holding negative attitudes, beliefs and emotions towards FIT screening. Following the MRC Framework for the Development of Complex Interventions and being theoretically informed, this work has the explicit intention of informing future interventions.

This proposal seeks to test efficacy in increasing uptake of two interventions among non responders: 1) including a test kit with the current reminder, and 2) an evidence-based and theoretically informed behavioural intervention (e.g. modified reminder letter, modified accompanying leaflet).

This study is a 2x2 factorial design non-randomised control trial. This design will test main effects of each intervention and investigate whether the two interventions interact (25). Individuals between the ages of 60-62 (new invitees) will be sampled from invitees who do not respond to the initial screening invitation and allocated to one of four trial arms using batch randomisation. The four trial arms will be:

1. Usual care - Standard reminder and no test kit
2. Standard reminder plus test kit
3. Theoretically informed behavioural intervention (modified reminder letter) at reminder and no test kit
4. Theoretically informed behavioural intervention at reminder with test kit The main effect of the test kit is estimated by comparing 2+4 vs 1+3; main effect of behavioural intervention is estimated from 3+4 vs 1+2.

Interventions to Improve Bowel Cancer Screening Uptake in Ireland: a 2x2 Factorial Trial

Participation rate in each arm by deprivation, sex and age

The National Screening Service

Newcastle University

University of Dublin, Trinity College

Dublin City University

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The current standard care text message reminder (SMS) that women routinely receive when being invited for their breast screening mammogram will be sent to the control group at 7 and 4 days before their timed appointment.

Intervention A will be a text message reminder (SMS) containing a behavioural regulation message. Women will be sent this SMS at 7 and 4 days prior to their timed appointment.

Intervention B will be a text message reminder (SMS) containing a priority message. Women will be sent this SMS at 7 and 4 days prior to their timed appointment.

SMS reminder with 'Behavioural Regulation' message:

'Don't forget to make a diary note of your screening mammogram apt at (time)(date) at (site). Call 02033136644 to rearrange'

Intervention A - Behavioural Regulation

SMS reminder with 'Priority' message:

'Is your breast screening appointment on your priority list? Apt at (time), (date) at (site). Call 02033136644 to rearrange.'

Intervention B - Priority

Sarah W Huf, MBBS BSc

Breast screening is a service offered by the NHS to help detect breast cancer and precancerous changes early at a time when treatment is more likely to be curative. An effective service must reach the 'at risk' but asymptomatic population. Breast screening uptake in London, consistently falls below the national target and is well below the national average. Uptake in West London is particularly low, with boroughs in Inner North West London having the some of lowest uptake rates in the country.

Routine text message reminders have proven effective at improving uptake of breast screening appointments. However little attention is paid to the content of the messages. Previous studies of text message reminders in other clinical areas have shown that the content of these messages matters and some text messages are more effective than others.

This protocol describes the design of a randomized controlled trial to investigate the effect of differently worded text messages on the engagement with breast screening in West London.

Two intervention arms were designed taking into consideration results of a 1000 woman survey to highlight the behavioural barriers that most predict attendance. The survey tested 15 behavioural constructs and the two that most strongly predicted history of attendance were used to inform the text message content of the intervention arms for this trial.

To this end, this randomised controlled trial (RCT) will test the current standard practice text message reminder against two intervention text message trial arms informed by the above described survey.

The setting is West of London Breast Screening Service and women aged 47-73 who are due for screening will be randomized to receive one of the three trial arms.

The primary outcome is the difference in uptake between trial arms. Further statistical analysis will analyse the difference in uptake by age group, deprivation score and previous attendance status.

Result will inform how small changes to the word content may have significant effects on attendance at screening mammogram appointments.

Background

In the UK breast cancer is the most common female cancer affecting 1 in 8 women, accounting for 31% of all cancers and 15% of cancer deaths in women.1 The NHS breast screening programme (NHSBSP) offers 3-yearly screening to women aged 50-70 years. A pilot of extended screening ages of 47-73 is being trialed in some geographical areas.

In 2015, 75% of women in England attended breast screening. In the same year only 68.3% of women in London and 65.9% in West London respectively had an up-to-day mammogram in the previous 3 years. 2 This falls below both the national average and target uptake of 70%. The success of a screening programme not only relies on the sensitivity of the screening tool and availability of successful treatment but also on reaching the asymptomatic but at risk population.

Recent evidence in breast screening has shown that a simple text message reminder (TMR) is effective. 3,4. One randomized controlled trial showed an increase in attendance by as much as 12%.5 As a result TMRs are being used more frequently by NHS organisations, but with little consideration paid their word content.

Further research testing the word content of TMR to remind patients of routine outpatient hospital appointments has shown that the word choice matters. The most effective message reduced 'did not attend' rates by 3.4 percentage points compared to a control TMR at a London Hospital. 6

Objective

This study aims to test if the word content of TMRs affects the uptake of breast screening.

Trial design

The investigators propose to collaborate with West of London Breast Screening Service (WoLBSS) to test different TMRs through an RCT to increase screening uptake.

The trial will test the effect of differently worded TMRs on the uptake of breast screening in eligible women in West London. This three-armed RCT will test two intervention arms against the current control arm.

Current practice is for women to receive two TMRs at 7 and 4 days prior to their appointment. Therefore the current message will be maintained as the control message for both TMR 1 (7 days prior to appointment) and TMR 2 (4 days prior to appointment). The intervention arms will contain the intervention TMRs and will be sent out as both TMR1 and TMR2. During the trial period women due for screening will be randomized to receive one of the three trial arms (control, intervention arm 1 or intervention arm 2. The TMRs will be sent out 7 days and 4 days before the breast screening appointment during the trial period as they are currently sent out as part of routine practice. Women will receive the same message on the 7th day and the 4th day before their appointment. WoLBSS will inform the research team of a woman's attendance status at the end of the screening rounds.

Methods:

Study setting

This study will be run in West London in collaboration with WoLBSS, which currently provides the routine TMR service based on data from a previous trial.5 The research team will work closely with the WoLBSS team to run the RCT through the existing infrastructure used to send out current messages.

Eligibility Criteria

Inclusion Criteria

Women who are eligible and due for breast screening in West London.

Exclusion Criteria

Women who are not eligible for breast screening due to for example bilateral mastectomies.

Women who have chosen to not have screening and have informed the screening centre or their GP.

Withdrawal Criteria

Any woman who chooses to not take part in screening or to receive a TMR and has informed the screening centre or their GP.

Interventions

The RCT will have three arms.

1. control (current TMR)
2. Intervention 1 - Behavioural regulation TMR
3. Intervention 2 - Priority TMR

The choice of the content of the intervention text messages has been based on a survey of 1000 women run by the research team that evaluated how 15 behavioural constructs predicted the outcome measures of women's history of attendance and their intention to attend. Two strong constructs that predict both history of attendance and intention to attend were 'behavioural regulation' i.e. making a plan/note in a diary to attend breast screening and 'priority' i.e. how much a woman feels that screening is a priority.

Therefore the word content of two TMRs was constructed to take these into account.

Both intervention TMRs have been reviewed and approved by the WoLBSS routine care team as well as the clinical lead for screening and a Public Health Consultant in Cancer screening at NHS England.

Control - (current TMR)

'Don't forget your breast screening appointment at (time) (date) at (Site). Please call 02033136644 to rearrange or cancel'

Intervention arm 1 - Behavioural Regulation

'Don't forget to make a diary note of your screening mammogram appt at (time) (date) at (site). Call 02033136644 to rearrange.'

Intervention arm 2 - Priority

'Is your breast screening appointment on your priority list? Apt at (time), (date) at (site). Call 02033136644 to rearrange.'

Outcomes

The primary end point is the rate of uptake of screening at the end of the screening round. Trial arms will be powered and sample size collected to detect a 3% uptake in screening. The trial will close when the sample size is reached.

The secondary outcomes are uptake according to age, deprivation score and previous history of attendance.

Participant Timeline

Women will be routinely invited for their screening mammogram as per standard procedure approximately three weeks before their appointment. The research team will then randomise an anonymized list of women to receive one of the three TMRs. The TMR will then be sent at the same times as the current standard TMRs are sent out 7 and 4 days prior to the appointment.

Sample Size

The sample size was calculated to detect a 3% difference in uptake between groups with a 5% margin for type I and 20% margin for type II error. This expected improvement in uptake is deemed to be both realistic and operationally significant to the service. The uptake in West London in 2015 was 65.9%. The investigators therefore calculated a minimum sample size for each trial arm to be 3,832 with a total sample size of 11,496.

Recruitment

For each screening round WoLBSS will invite women for breast screening as per usual. It is not possible to identify at the time of randomization which women have provided WoLBSS with their phone number. For this reason all women due for screening will be randomised. However, only women who have given their mobile phone number will be able to receive a TMR.

Randomisation

Each screening round a list of women will be forward to iPlato Patient Care Messaging with their allocated appointment date, time and location. The participant list will then be randomised by iPlato into trial arms and allocated to receive one of the three TMRs using the Mersenne Twister algorithm.

Once randomised the list of women due for screening will be uploaded to the iPlato platform. The iPlato system will link each patients NHS number to WoLBSS record and retrieve a mobile phone number where one is available.

WoLBSS uses iPlato Patient Care Messaging currently to send out the existing text message reminder. iPlato is a communication platform developed specifically for health services and can send reminder messages on behalf of GPs and hospitals.

Data collection and management

Data will be collected by the WoLBSS IT system including the primary research outcome of attendance status. iPlato will collect data on accuracy of phone numbers and messages delivery status. Anonymised data will be retrieved and passed onto the research team. The data will be handled on NHS N3 computers with password protection, the research team's personal laptops with secure password protection and Imperial College London's secure virtual private network. Any transmission of data via email will be within secure NHS.net and NHS trust email accounts between WoLBSS and the research team and within the secure Imperial College email accounts and the virtual private network amongst the research team.

Data collected will include the age, year of birth, first 3-4 digits of the postcode, ethnicity, previous attendance history and availability of a mobile phone number.

It is possible that participants are subject to other trials however due to the nature of the trial it is not appropriate to contact patients to find out. It is not necessary in terms of impact on the results.

Consent

The premise of the study is whether a subtle change in a text message can increase the number of patients attending their breast screening appointment. A pre-warning that patients may receive TMR that may be modified would undermine the premise of the study and affect results. This is because of participation bias, which would indicate that subjects who know they are participating in a trial are more likely to try and do what they think the researcher wants them to do. Taking explicit consent would therefore also undermine the study design.

Only women who have given them mobile phone number to WoLBSS directly, will be able to receive a TMR prior to their appointment. Therefore they have in the past given explicit consent to receive a TMR by the service. No woman who has not previously given her mobile number to the service will receive a TMR.

Does the Wording of Text Message Reminders Improve Uptake in Breast Screening?

Does the Wording of Text Message Reminders Improve Uptake in Breast Screening? A Randomised Controlled Trial

There is no intention to make individual participant data available. Data will be analysed at aggregate level.

Each patient is invited to an individual timed appointment. The outcome measure will be assessed based on if women attend their timed appointment. Usually this is within a month of the invitation letter being sent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Can Text Reminders Improve Uptake of Cervical Screening?	NCT02363088	Cervical Carcin... Cervical Dyspla...	Neutral text me... Messenger text ... Social Norms A ... Social Norms B ... Framed Gain tex... Framed Loss tex...	24 Years - 64 Years	Imperial College Healthcare NHS Trust
Lung Screen Uptake Trial	NCT02558101	Lung Cancer	Control invitat... Intervention in...	60 Years - 75 Years	University College, London
Lung Screen Uptake Trial	NCT02558101	Lung Cancer	Control invitat... Intervention in...	60 Years - 75 Years	University College, London
Interventions to Improve Bowel Cancer Screening Uptake in Ireland: a 2x2 Factorial Trial	NCT05609396	Colorectal Canc...	Behaviorally en...	60 Years - 64 Years	Dublin City University
Lung Screen Uptake Trial	NCT02558101	Lung Cancer	Control invitat... Intervention in...	60 Years - 75 Years	University College, London
Lung Screen Uptake Trial	NCT02558101	Lung Cancer	Control invitat... Intervention in...	60 Years - 75 Years	University College, London
Does the Wording of Text Message Reminders Improve Uptake in Breast Screening?	NCT02872363	Breast Cancer Breast Disease	Intervention A ... Intervention B ...	20 Years - 100 Years	Imperial College Healthcare NHS Trust
Does the Wording of Text Message Reminders Improve Uptake in Breast Screening?	NCT02872363	Breast Cancer Breast Disease	Intervention A ... Intervention B ...	20 Years - 100 Years	Imperial College Healthcare NHS Trust
Interventions to Improve Bowel Cancer Screening Uptake in Ireland: a 2x2 Factorial Trial	NCT05609396	Colorectal Canc...	Behaviorally en...	60 Years - 64 Years	Dublin City University

Spots Global Cancer Trial Database for uptake

Every month we try and update this database with for uptake cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for uptake

Every month we try and update this database with for uptake cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for uptake cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.