Using text message reminders and culturally-tailored telephone calls to promote participation in bowel cancer screening (TOPPS)
| ISRCTN | ISRCTN17245519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17245519 |
| IRAS number | 299034 |
| Secondary identifying numbers | 150666, IRAS 299034 |
- Submission date
- 15/09/2022
- Registration date
- 20/02/2023
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bowel cancer is a leading cause of cancer-related death in England. Several large studies have shown that screening can improve bowel cancer outcomes by detecting cases early. In light of this, NHS England initiated a national bowel cancer screening programme (BCSP) in 2006. Since then, uptake has been consistently low, falling from 54% in 2010 to 49% in 2015. Further, in London, participation in bowel cancer screening is particularly low in regions where there is high ethnic diversity.
However, previous research suggests that it is possible to improve screening uptake by using text message reminders and patient navigation (one-to-one support and guidance for patients throughout their decision-making regarding screening). This study aims to compare the effectiveness, and cost-effectiveness, of these two strategies to increase bowel cancer screening participation in six areas in London, where screening uptake is known to be low. This will provide policy-decision makers with the information needed to commission these services.
Who can participate?
Men and women aged 60-74 years registered with a participating general practice located within the London Boroughs of Brent, Ealing, Lambeth, Lewisham, Redbridge and Barking and Dagenham, who have not returned a bowel cancer screening kit within 13 weeks of delivery
What does the study involve?
Over a 4-week period, participants will be allocated (at random) to groups receiving either usual care, text message reminders at 13, 15, 17,19 weeks of non-response, or a text message reminder at 13 weeks plus patient navigation at 15, 17, 19 weeks of non-response.
What are the possible benefits and risks of participating?
The risks and burdens to participants are minimal. The NHS Bowel Cancer Screening invitation process will continue, unaffected by this study. Only those who do not participate within 13 weeks of invitation will be included in the study. These individuals will either receive no intervention (usual care), one or more text message reminders (depending on if/how soon they respond), or a call to discuss and rectify any barriers to attendance to support self-referral (patient navigation).
There is potential that participants may feel that they are receiving too much information about bowel cancer screening, or are being coerced into participating in bowel cancer screening. However, the researchers will endeavour to ensure the interventions focus on enhancing informed choice and are delivered at suitable time points to not overwhelm individuals. This study benefits from a developmental phase, whereby people will help develop intervention content, and lay representatives will provide valuable input to the final designs. An advisory group and a steering group have also been established for this study and potential risks and burdens to participants will be addressed.
The main benefits of this study are that they may encourage participation in bowel cancer screening, which may help detect some bowel cancers at an earlier stage. The early detection of bowel cancer may, in turn, lead to improved cancer experience (e.g. less invasive treatment) and improved chances for survival.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
August 2021 to October 2024
Who is funding the study?
NHS England (UK)
Who is the main contact?
Dr Robert Kerrison, Robert.Kerrison.13@ucl.ac.uk
Contact information
Principal Investigator
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
 ORCID ID |
0000-0002-8900-749X |
|---|---|
| Phone | +44 (0)20 7679 1722 |
| Robert.Kerrison.13@ucl.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Exploring the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London: a randomised controlled trial |
| Study acronym | TOPPS |
| Study hypothesis | 1. Bowel cancer screening non-responders who receive text message reminders 12 weeks after being sent a screening kit will be more likely to complete and return a test kit, compared with those who do not receive text message reminders (usual care). 2. Bowel cancer screening non-responders who receive text message reminders and telephone patient navigation 12 weeks after being sent a screening kit will be more likely to complete and return a test kit, compared with those who do not receive text message reminders or telephone patient navigation (usual care). 3. Bowel cancer screening non-responders who receive text message reminders and telephone patient navigation 12 weeks after being sent a screening kit will be more likely to complete and return a test kit, compared with those who receive text message reminders only. |
| Ethics approval(s) |
Approved 09/03/2023, Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 22/WM/0212 |
| Condition | Bowel cancer screening |
| Intervention | Participants will be randomised using computerised, pseudo-random, number allocation (performed using the 'RAND' function within Excel). Individuals will be randomised in equal proportions (1:1:1) to receive either: 1. No intervention (‘usual care only’), 2. A text-message reminder, 13 weeks after invitation, with additional text-message reminders at 15, 17 and 19 weeks, if there is no response (‘usual care + text message reminder(s)), or 3. A text-message reminder, 13 weeks after invitation, followed by PN calls at 15, 17 and 19 weeks, if there is no response (‘usual care + a text message reminder + PN telephone call(s)) |
| Intervention type | Behavioural |
| Primary outcome measure | Participation in screening, defined as returning a completed FIT kit, within 24 weeks of dispatch |
| Secondary outcome measures | The proportion of participants who receive a positive bowel cancer screening test kit result, within 26 weeks of being sent their test kit |
| Overall study start date | 01/08/2021 |
| Overall study end date | 30/10/2024 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 2703 |
| Participant inclusion criteria | 1. Men and women aged 60-74 years 2. Have not returned a bowel cancer screening kit within 13 weeks of delivery 3. Registered with a participating general practice located within the London Boroughs of Brent, Ealing, Lambeth, Lewisham, Redbridge and Barking and Dagenham |
| Participant exclusion criteria | Exclusions will be made according to ‘Type-2 objector’ status, which is defined as: “a request, expressed by a registered patient, logged with a GP Practice, to indicate that personal identifiable information relating to them should not be disseminated or published by NHS Digital. |
| Recruitment start date | 01/08/2024 |
| Recruitment end date | 01/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
NW1 5JD
United Kingdom
London
SE1 2TZ
United Kingdom
5 Station Street
London
E15 1DA
United Kingdom
Sponsor information
University/education
UCLH/UCL Joint Research Office, part of the Research Directorate
4th Floor, West
250 Euston Road
London
NW1 2OG
England
United Kingdom
| Phone | +44 (0)20 7679 2000 |
|---|---|
| pushpsen.joshi1@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The results of this study will be reported in peer-reviewed journals and presented at scientific conferences. In addition, the funding body and the stakeholders (in particular the management of the Bowel Cancer Screening programme) will be informed of the results prior to publication, in case the results merit action in terms of policy or practice. |
| IPD sharing plan | At the end of the study, an anonymised version of the study database will be made available on Open Science Framework. Eligible patients registered at a participating GP practice will be identified by NHS Digital. This list will be transferred securely to an encrypted cloud-based server (iPlato) for randomisation and intervention delivery. Following completion of the study period, this database will be transferred back to NHS digital for data on cancer screening participation (and outcome) to be extracted and anonymised, and relevant participant information to be attached. This will include ‘sex’, ‘age’, ‘index of multiple deprivation quintile’. The anonymised dataset will then be transferred to UCL’s Data Safe Haven for analysis. Consent will not be required at the participant level for research of this nature and will be given by GP participation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 25/06/2024 | 25/06/2024 | Yes | No |
Editorial Notes
25/06/2024: Publication reference added.
29/04/2024: The following changes were made:
1. The recruitment start date was changed from 01/04/2024 to 01/08/2024.
2. The recruitment end date was changed from 01/06/2024 to 01/10/2024.
3. The overall study end date was changed from 30/09/2024 to 30/10/2024.
14/12/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 02/01/2023 to 01/04/2024.
2. The recruitment end date was changed from 30/01/2023 to 01/06/2024.
12/12/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2023 to 30/09/2024.
2. The intention to publish date was changed from 30/12/2023 to 30/12/2025.
3. The plain English summary was updated to reflect these changes.
4. The ethics approval was added.
22/09/2022: Trial's existence confirmed by NHS England.
