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SWEET

Hospital ward

Key information

Title:

Improving outcomeS for Women diagnosed with early breast cancer through
adhErence to adjuvant Endocrine Therapy (SWEET)

Chief Investigator: Professor Linda Sharp & Professor Eila Watson

Sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust

Funder: National Institute for Health and Care Research (NIHR)
Programme Grant for Applied Research (PGfAR), project number: NIHR200098

Registration Number: IRAS ID - 330129. ISRCTN24852890.

Summary:

Many women are prescribed hormone therapy following diagnosis and hospital treatment for
breast cancer. Hormone therapy significantly reduces the chances of breast cancer returning. Usually,
women are recommended to take hormone therapy, in the form of a daily tablet, for several years.
However, we know that some women either do not take this medication everyday as prescribed or
sometimes stop taking it all together (known as “poor adherence”); this can increase their risk of
breast cancer returning.
We have developed a support package (called HT&Me) which aims to encourage and support women
to take their hormone therapy as prescribed, and hopefully reduce the risk of breast cancer returning.
The purpose of the SWEET study/practitioner is to investigate whether the HT&Me support package can improve hormone therapy adherence, and quality-of-life when compared to the standard NHS follow-up care.

Participants will be randomised on a 1:1 basis to receive either the HT&Me support package (+usual care), or usual care alone.

Sample size:

1460 women, across up to 80 NHS sites.

Primary outcome:

Adjuvant endocrine therapy adherence (AET): Combined self-report (Medical Adherence Report Scale (MARS-5) and prescription encashment records (e.g. Medication Possession Ratio (MPR)

Cancer specific health related quality of life: Functional Assessment of Cancer Therapy scale General (FACT-G)

Duration:

1st January 2024 – 18th November 2027 with recruitment from 1st Jan 2024- 31st December 2025.

Participant population:

Women recently diagnosed with ER-positive invasive breast cancer, stages 1- 3 and treated with curative intent, who have been prescribed oral AET within the past 3 months.

What does the HT&Me support package involve?

Participants randomised to receive access to the HT&Me Support Package will receive:

  • A consultation of around 30 minutes with a HT&Me study nurse/practitioner to discuss hormone therapy, answer any questions and introduce the HT&Me website.
  • Access to the HT&Me website which contains short videos, information, tips & tools to
    support women to take their hormone therapy every day (e.g. setting reminders to take hormone therapy or ordering repeat prescriptions), providing tips for managing side-effects and signposting for further support.
  • A follow up consultation after 12 weeks with the HT&Me study nurse/practitioner to discuss any new concerns and review use of the HT&Me web app.
  • Regular motivational messages delivered by email or text, promoting adherence and encouraging use of the web-app.

Sites Open: 27/80

Recruitment: 162/1460


Link to Recruitment Animation

Contact Us: SWEET@warwick.ac.uk 

The SWEET team:

Trial Manager - Raegan Barrows

Trial Coordinator - Anna Mann