Supporting Women with adhErence to hormonE Therapy following breast cancer (SWEET): the feasibility study

ISRCTN	ISRCTN29401613
DOI	https://doi.org/10.1186/ISRCTN29401613
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	307011
Protocol serial number	CPMS 52782, IRAS 307011
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	National Institute for Health and Care Research Central Commissioning Facility (CCF); Grant Codes: NIHR200098

Submission date: 13/07/2022
Registration date: 12/08/2022
Last edited: 02/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-support-women-to-take-their-hormone-therapy-following-breast-cancer-sweet

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 five 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 cancer returning and dying from cancer. At least 20% of women have poor adherence after two years and around 50% by five years. Our 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 is supported by a Patient Advisory Group and Clinical Reference Group, which will develop and test a support package to support women taking ET as recommended. The feasibility study will run at up to five NHS clinical sites and use mixed methods to inform the potential for a larger randomised controlled trial (RCT), answering the following key questions:
1. Can we identify and recruit potentially eligible patients?
2. Is it feasible to deliver the initial face-to-face intervention consultation within 8 weeks of recruitment?
3. Are the baseline and follow-up questionnaires acceptable?
4. Do women find the different components of the intervention acceptable and useful?
5. What is the timeliness and quality of primary care prescription encashment data, and is it possible to use this to compute an objective measure of adherence to adjuvant endocrine therapy (AET)?

Who can participate?
Sub-study 1: Women recently diagnosed with early-stage ER-positive invasive breast cancer and prescribed oral AET (in the past 3 months), who have a medium or high risk of recurrence.

Sub-study 2: Women diagnosed with early-stage ER-positive invasive breast cancer and prescribed oral AET in the previous 9-36 months.

What does the study involve?
Sub-study 1: Participants will receive the intervention (HT&Me support package) and will be followed for 7-9 weeks. As part of the HT&Me support package, participants will be offered an initial appointment with a study nurse who will ask women about their experiences of hormone therapy so far and will show them the HT&Me website and how it works. Some consultations may be recorded so that the research team can review how they went. Participants will also have access to a follow-up consultation to check how they are getting on with their hormone therapy and ask about their experiences with the website. Participants will then be asked to complete a follow-up questionnaire, and a sub-sample will undergo interviews. Interviews will also be conducted with a sample of health professionals involved in the study.

Sub-study 2: The AET prescribing history for each individual recruited woman will be obtained through linkage of the cohort to the National Cancer Registration Database (NCRD) and the NHS Business Services Authority (BSA) Primary Care Prescribing Database (PCPD). This will provide information on timeliness and completeness. If this information cannot be collected via NHS digital we will seek to obtain this information through GP records.

What are the possible benefits and risks of participating?
Participants may find taking part in this research helpful as you will be provided with additional information and support in relation to taking hormone therapy. Participants will also be contributing to research which could help women with breast cancer who are taking hormone therapy in the future. As a thank you to women that take part in additional interviews at the end of the study, we will be offering a £30 high street voucher.

Participating in qualitative research and completing questionnaires may have emotional consequences for the participant and may involve them considering and discussing potentially upsetting issues related to their own experiences. Participants do not have to answer any questions they do not feel comfortable answering and they can take a break during consultations or interviews if they wish.

Where is the study run from?
Newcastle NHS Foundation Trust, Imperial College Healthcare Trust, Oxford University Hospitals, (with the potential addition of Great Western Hospital) (United Kingdom)

When is the study starting and how long is it expected to run for?
March 2022 to November 2023

Who is funding the study?
National Institute for Health and Care Research (NIHR) Programme Grant for Applied Research (PGfAR) (United Kingdom)

Who is the main contact?
SWEETStudy@ncl.ac.uk (United Kingdom)

Contact information

Prof Linda Sharp
Principal investigator

Professor of Cancer Epidemiology/Honorary Research Contract (NuTH)
Newcastle University
Level 5, Sir James Spence Institute
Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE1 4LP
United Kingdom

Phone	+44 (0)1912086275
Email	SWEETStudy@ncl.ac.uk

Prof Eila Watson
Principal investigator

Oxford Brookes University
Oxford School of Nursing and Midwifery
Oxford
OX3 0BP
United Kingdom

Phone	+44 (0)1865 482665
Email	ewatson@brookes.ac.uk

Ms Alice Longe
Public

Clinical Trial Manager
Warwick Clinical Trials Unit
University of Warwick
Coventry
CV4 7AL
United Kingdom

Phone	None available
Email	alice.longe@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Non-randomized single-arm interventional study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Improving outcomes for women diagnosed with early breast cancer through adherence to adjuvant endocrine therapy: the feasibility study
Study acronym	SWEET
Study objectives	The provision of a tailored support package for women with breast cancer (at moderate or high risk of recurrence) is feasible and acceptable
Ethics approval(s)	Approved 18/05/2022, South Central – Hampshire A - Health Research Authority (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8196; hampshirea.rec@hra.nhs.uk), ref: 22/SC/0150
Health condition(s) or problem(s) studied	Breast Cancer
Intervention	Sub-study 1 is a single-arm, non-randomised feasibility study to explore the acceptability and feasibility of delivering the SWEET intervention (HT&Me support package). Recruited women (n=45) will receive the intervention and will be followed for 7-9 weeks, at which point they will complete a follow-up questionnaire, and a sub-sample will undergo interviews. Interviews will also be conducted with a sample of health professionals involved in the study (n=15-18). Sub-study 2 is a retrospective cohort study which will test the processes for obtaining prescription encashment data for a small cohort of women (n=45) with breast cancer initially prescribed adjuvant endocrine therapy (AET) at the hospital (thereby testing, on a small scale, the processes that will require to be followed in the subsequent RCT). The AET prescribing history for each individual recruited woman will be obtained through linkage of the cohort to the National Cancer Registration Database (NCRD) and the NHS Business Services Authority (BSA) Primary Care Prescribing Database (PCPD). This will provide information on timeliness and completeness.
Intervention type	Other
Primary outcome measure(s)	Sub-study 1: 1. Optimal patient recruitment pathways measured using patient and health care provider (HCP) interviews at around 8-9 weeks post initial consultation and by review of patient screening logs recorded at time of assessment of eligibility 2. Feasibility of recruiting women to receive the intervention measured using patient and HCP interviews at around 8-9 weeks post initial consultation and by review of: 2.1. Patient screening logs recorded at the time of assessment of eligibility 2.2. Information recorded on reasons why women declined to take part (decliner log), recorded at the time of recruitment 3. Feasibility of delivering the intervention measured as percentages of recruited women who: 3.1. Received the initial nurse consultation within 8 weeks of recruitment 3.2. Accessed the web app during their time in the study, determined from the questionnaire and analytic data at 8-9 weeks post initial consultation and from HCP interviews at 8-9 weeks post initial consultation 4. Acceptability and usefulness of the HT&Me intervention to patients measured using patient and HCP interviews at around 8-9 weeks post initial consultation 5. Barriers to, and facilitators of, trial implementation, including: 5.1. Willingness of staff to recruit women to a randomised controlled trial (RCT) measured using HCP interviews at around 8-9 weeks post initial consultation 5.2. Willingness of women to be recruited and randomised to an RCT measured using patient interviews and follow-up questionnaire at around 8-9 weeks post initial consultation 6. Test processes for collecting self-reported outcome data measured using patient questionnaires at baseline and at 8 weeks after the initial consultation Sub-study 2: 7. Test processes for obtaining prescription encashment data for a small cohort of women with breast cancer initially prescribed adjuvant endocrine therapy some months previously measured retrospectively using prescription data from NHS digital or GP records, collected prior to the end of a feasibility study (June 2022)
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	30/11/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	90
Total final enrolment	115
Key inclusion criteria	Sub-study 1 Inclusion criteria: The following patients will be eligible: 1. Aged 18 years old and over 2. Female 3. Diagnosis of ER-positive invasive breast cancer 4. Medium or high risk of recurrence, defined as one of the following: 4.1. T2 and N0 4.2. T2 and N>0 4.3. T1 and N>0 4.4. T1 and N0 and grade 3 5. Within 3 months of first oral adjuvant endocrine therapy (AET) prescription (tamoxifen or aromatase inhibitor) 6. Completed surgery 7. Completed chemotherapy (if applicable) 8. Can access the internet and have an email address 9. Are willing to use a support package with a web-based component Sub-study 2 Inclusion criteria: The following patients will be eligible: 1. Aged 18 years old and over 2. Female 3. Diagnosis of ER-positive invasive breast cancer 4. Medium or high risk of recurrence, defined as one of the following: 4.1. T2 and N0 4.2. T2 and N>0 4.3. T1 and N>0 4.4. T1 and N0 and grade 3 5. Were first prescribed oral AET (tamoxifen or aromatase inhibitor) within the past 9-36 months 6. Have completed surgery 7. Have completed chemotherapy (if applicable)
Key exclusion criteria	Sub-study 1 and 2 exclusion criteria: The following patients with early-stage ER+ve invasive breast cancer will be ineligible: 1. Male 2. Have been prescribed adjuvant CDK4/6i (abemaciclib) 3. Have cognitive impairment sufficient to preclude participation, as judged by the clinical team 4. Are unable to read and understand English 5. Had previous AET (for another breast cancer) 6. Have not had surgery for breast cancer
Date of first enrolment	01/09/2022
Date of final enrolment	31/07/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Freeman Hospital

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

St Marys Hospital

South Wharf Road
London
W2 1BL
United Kingdom

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (details to be confirmed)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 3.0	21/07/2022	08/08/2022	No	Yes

Additional files

42059 Protocol - SWEET Feasibility study v3.0 21.07.2022 - Clean.pdf: Protocol file

Editorial Notes

02/07/2025: The study record was confirmed as being up to date.
20/11/2024: Total final enrolment added.
28/07/2023: The public and scientific titles were updated to add "the feasibility study".
15/06/2023: The recruitment end date was changed from 30/06/2023 to 31/07/2023.
15/06/2023: Cancer Research UK plain English summary link added to plain English summary field.
12/05/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2023 to 30/06/2023.
2. The overall trial end date was changed from 31/10/2023 to 30/11/2023.
3. The intention to publish date was changed from 31/10/2024 to 30/11/2024.
12/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 30/04/2023.
2. The overall trial end date was changed from 30/06/2023 to 31/10/2023.
3. The intention to publish date was changed from 30/06/2024 to 31/10/2024.
13/07/2022: Trial's existence confirmed by the NIHR.