Supporting women with adherence to hormone therapy following breast cancer
| ISRCTN | ISRCTN24852890 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24852890 |
| IRAS number | 330129 |
| Secondary identifying numbers | CPMS 57385, IRAS 330129 |
- Submission date
- 27/07/2023
- Registration date
- 02/08/2023
- Last edited
- 11/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
In 2016, 11,563 women died from breast cancer in the UK. Most would have been prescribed hormone therapy (HT); sometimes known as endocrine therapy, which blocks the effect of oestrogen on breast cancer cells. HT is prescribed as a daily tablet, usually for at least 5 years and often up to 10 years. When women stop taking HT prematurely, or don’t take it as prescribed (known as “poor adherence”), they have up to a three times higher chance of the cancer returning and dying from cancer. At least 20% of women have poor adherence after 2 years and around 50% by 5 years. Previous research has identified reasons for poor adherence, including feeling negative or concerned about HT; not fully understanding its importance; side-effects; feeling unsupported; and forgetfulness. SWEET is an NIHR-funded research programme which, supported by a Patient Advisory Group and Clinical Reference Group, will develop and test a support package to support women taking treatment as recommended. The aim of this study is to determine the clinical effectiveness of the trial intervention in reducing poor adherence to treatment and improving quality of life.
Who can participate?
Women recently diagnosed with ER-positive invasive breast cancer, stages 1- 3 and treated with curative intent, who have been prescribed oral adjuvant endocrine therapy (AET) within the past 3 months
What does the study involve?
Participants randomly allocated to Group A will receive access to the HT&Me Support Package which involves:
A consultation of around 30 minutes with a HT&Me study nurse (either based at your local hospital site, or via the charity Breast Cancer Now) to discuss hormone therapy, answer any questions you might have and introduce the HT&Me website. This appointment may be delivered in person, by video call or if required by telephone call, appointments with a Breast Cancer Now nurse will always be completed over video call.
Access to the HT&Me website which contains short videos, information, tips & tools to support you to take hormone therapy every day (e.g. set reminders to take hormone therapy or order repeat prescriptions), get tips for managing side effects, and information about how to get further support.
After 12 weeks, participants will have a follow-up consultation with the HT&Me study nurse to see how they are getting on with their hormone therapy and the HT&Me website. For a few women, the researchers might record their consultations; this is simply to check what information they have been given and that the consultations are going as planned. They may also be asked to provide feedback on the appointments by text message.
Participants will also be sent some messages by email or text, to remind them about the importance of taking hormone therapy and that the website may be a useful resource.
Participants randomly allocated to Group B will continue with their usual NHS care and hormone therapy as prescribed.
What are the possible benefits and risks of participating?
It is not known whether the HT&Me support package will be effective in helping women to continue taking their hormone therapy as prescribed or in improving quality-of-life, however, women in Group A who receive the intervention will receive more information and support whilst taking their hormone therapy and they may find this helpful. Participants may not directly benefit from taking part in this research, but your participation will help guide support for women with breast cancer taking hormone therapy in the future. There are no physical risks involved in taking part in the study, although being asked questions about cancer may be upsetting
Where is the study run from?
Warwick Clinical Trials Unit, University of Warwick (UK)
When is the study starting and how long is it expected to run for?
May 2023 to June 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
SWEET@warwick.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-helping-women-stay-on-hormone-therapy-after-breast-cancer-sweet
Contact information
Principal Investigator
Newcastle University
Level 5
Sir James Spence Institute
Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE1 4LP
United Kingdom
| Phone | +44 (0)1912086275 |
|---|---|
| SWEET@warwick.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural, Management of Care, Other, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Supporting Women with adhErence to hormonE Therapy following breast cancer (SWEET) |
| Study acronym | SWEET |
| Study objectives | Provision of a tailored support package for women with breast cancer (at moderate or high risk of recurrence) who are prescribed adjuvant hormone therapy reduces poor adherence and improves quality of life. |
| Ethics approval(s) | Approved 11/08/2023, South Central – Hampshire B (2 Redman Place, Stratford, Health Research Authority, E20 1JQ, UK; +44 (0)207 104 8088; hampshireb.rec@hra.nhs.uk), ref: 23/SC/0254 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | SWEET is a multi-centre, unblinded, pragmatic randomised controlled trial (RCT) of HT&Me intervention + usual care vs usual care alone. The aim is to determine the clinical effectiveness of the trial intervention in reducing poor adherence to AET and improving cancer-specific HRQoL. SWEET plans to recruit 1460 women, across up to 80 sites. Patients who are confirmed to be eligible will be invited to take part in the study and if, following review of the patient information sheet, they decide to participate, written, or remote verbal informed consent will be obtained. The target population will be women with invasive ER+ve breast cancer, stages 1 – 3 treated with curative intent, who have been prescribed adjuvant endocrine therapy (AET) within the past 3 months. Baseline: Prior to randomisation, participants will be issued with a baseline questionnaire and health resource use questionnaire, as well as providing clinical information. Personal information (name, contact details and NHS number) will be collected for the purpose of creating HT&Me accounts where required, and for data linkage. Participants will be randomised on a 1:1 basis to receive either: HT&Me intervention, which includes: 1. Initial consultation with a SWEET nurse/practitioner (either at site, or remotely via Breast Cancer Now) to introduce the HT&Me intervention, discuss the patient’s beliefs and concerns about AET, and experiences of AET. 2. Access to the HT&Me web app which contains a short animation, information, tips & tools to support adherence including optional daily reminders to take AET or order repeat prescriptions, strategies for managing side effects, and signposting to further support 3. Follow-up consultation with a SWEET nurse/ practitioner (either at site, or remotely via Breast Cancer Now) to discuss any new concerns and review the use of the HT&Me web app. Participants will also be asked to complete a feedback questionnaire on their experience of the HT&Me support package 4. Regular motivational messages delivered by email or text, promoting adherence and encouraging the use of the web app. Usual care: Participants randomised to usual care alone will continue to access AET as per institutional guidelines and will continue to be followed up (either at site or through their GP) as per institutional guidelines and follow-up processes. Follow-up: Patients will be followed up by a questionnaire at 6 months, 12 months and 18 months for adherence and HRQoL. Sites will be responsible for the distribution of questionnaires to participants. Participants may be followed up for up to 15 years longer-term data linkage (subject to additional funding). Process evaluation: A parallel process evaluation will be undertaken, using a mixture of qualitative and quantitative methods. The aims of the process evaluation are to: 1. Explore fidelity of the intervention as delivered, received and enacted 2. Assess whether the intervention worked as hypothesized by the logic model 3. To identify any moderating contextual factors and/or unintended consequences of the intervention. Semi-structured telephone interviews will be conducted throughout the trial with participants (Arm A- HT&Me intervention, n=25-30; Arm B (control), n=10-15) to discuss their experience of the study. Interviews with SWEET study practitioners (n=20-25) will also take place. These interviews will explore: 1. Views and experiences of the trial, intervention and Behaviour Change Techniques (BCTs) (as appropriate) 2. Intervention fidelity and quality 3. Potential contamination 4. Contextual factors |
| Intervention type | Other |
| Primary outcome measure | AET adherence using combined self-report (Medical Adherence Report Scale (MARS-5) and prescription encashment records (e.g. Medication Possession Ratio (MPR); Timepoint(s): Baseline, 6 months, 12 months and 18 months |
| Secondary outcome measures | 1. Cancer-specific HR-QOL using Functional Assessment of Cancer Therapy scale- General (FACT-G); Timepoint(s): Baseline, 6 months, 12 months and 18 months 2. AET-specific HRQoL using Breast Cancer Trialist Prevention Checklist (BCPT; Timepoint(s): Baseline, 6 months, 12 months and 18 months 3. Cost-effectiveness using within-trial cost per quality-adjusted life year (QALY); QALYs; resource use and cost to NHS, patients and society, and EQ-5D-5L; Timepoint(s): Baseline, 6 months, 12 months and 18 months 4. Extent of adherence using MPR (continuous); encashment records and/or GP prescribing records throughout the study 5. Suboptimal implementation self-reported using MARS-5; Timepoint(s): Baseline, 6 months, 12 months and 18 months 6. Non-persistence, self-reported using >180 days gap in AET prescriptions; Timepoint(s): Baseline, 6 months, 12 months and 18 months |
| Overall study start date | 31/05/2023 |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1460; UK Sample Size: 1460 |
| Key inclusion criteria | 1. Aged 18+ years 2. Female 3. Diagnosis of ER-positive invasive breast cancer, stages 1-3 and treated with curative intent 4. Completed surgery for breast cancer 5. Within 3 months of first oral AET prescription (tamoxifen or aromatase inhibitor) post breast cancer completion surgery 6. Completed chemotherapy (if applicable) 7. Able to access the internet 8. Has an email address 9. Are willing to use a support package with a web-based component |
| Key exclusion criteria | 1. Male 2. Evidence of metastatic disease i.e. stage 4 disease (M1 regardless of T and N status) 3. Have cognitive impairment sufficient to preclude participation, as judged by the clinical team 4. Had previous AET (for another breast cancer) 5. Are unable to read and understand English |
| Date of first enrolment | 26/03/2024 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Wigan
WN1 2NN
United Kingdom
Poole
BH15 2JB
United Kingdom
Taunton
TA1 5DA
United Kingdom
London
N19 5NF
United Kingdom
St Albans
St. Albans
AL3 5PN
United Kingdom
Skipton Road, Steeton
Keighley
BD20 6TD
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Harlow
CM20 1QX
United Kingdom
West Wing
Milton Road
Portsmouth
PO3 6AD
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Winchester
SO22 5DG
United Kingdom
Caradoc Road
Aberystwyth
SY23 1ER
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Redhill
RH1 5RH
United Kingdom
Darlington
DL3 6HX
United Kingdom
Liverpool
L7 8XP
United Kingdom
Glasgow
G12 0YN
United Kingdom
Bury Saint Edmunds
IP33 2QZ
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Boston
PE21 9QS
United Kingdom
Coventry
CV2 2DX
United Kingdom
Stockton-on-tees
TS19 8PE
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Livingston
Lothian
EH54 6PP
United Kingdom
Larbert
FK5 4WR
United Kingdom
St. Leonards-on-sea
TN37 7RD
United Kingdom
Northwood
HA6 2RN
United Kingdom
College Street
Nuneaton
CV10 7DJ
United Kingdom
Brighton
BN2 5BE
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Ashton-under-lyne
OL6 9RW
United Kingdom
Sponsor information
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom
| Phone | +44 (0)191 2825959 |
|---|---|
| tnu-tr.sponsormanagement@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The dissemination and publication plan includes conference presentations, scientific papers, regular social media and lay communications, and briefings (paper, digital and events) for clinical teams, patient groups and commissioners within 1 year of the overall study end date. |
| IPD sharing plan | The datasets generated during the current study will be available upon request through the CI (SWEET@warwick.ac.uk) after trial publication. A proposal describing the purpose, scope, data items requested, and analysis plan and including appropriate acknowledgement of the SWEET trial management group) should be provided for approval from the SWEET TMG. Any data transfer would be in accordance with the University of Warwick SOPs and require data sharing/processing agreements to be in place. Participant Consent for future research is requested. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 4.0 | 08/04/2024 | 08/07/2024 | No | No |
Additional files
Editorial Notes
11/02/2025: Cancer Research UK link added to plain English summary field.
21/08/2024: Ethics approval details, acronym and study website added. The recruitment start date was changed from 30/09/2024 to 26/03/2024.
09/07/2024: Ethics approval details added. The recruitment start date was changed from 01/01/2024 to 30/09/2024.
08/07/2024: Protocol uploaded.
28/07/2023: Study's existence confirmed by the NIHR.
