Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: ISRCTN17334319

Activo, sin reclutamiento

The ROSETA Optimisation Trial – Investigating strategies to improve medication adherence in women with early-stage breast cancer

Intervencionista

Fase no especificada

St Luke's Hospital

Patrocinador: University of Leeds

Última actualización: 21 de octubre de 2025

Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence at 12 months post-randomisation. This trial will also have an embedded Study Within a Trial (SWAT), a self-contained research study that has been embedded within the host trial to evaluate ways of delivering follow-up trial processes. The overall aim of the SWAT is to understand the impact of SMS pre-notification and reminder messages in the context of clinical trials using online data capture for patient-reported questionnaires.

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Categoría de tratamiento

Erforderliche Mutationen

Ensayo iniciado

1 de enero de 2023

Última actualización por el patrocinador

21 de octubre de 2025

Finalización estimada

30 de noviembre de 2026

Contacto del estudio

Nombre:Prof Sam Smith

Correo electrónico:S.Smith1@leeds.ac.uk

Teléfono:+44 (0)113 343 0892

Nombre:Dr ROSETA Optimisation Trial Team

Correo electrónico:ROSETA@leeds.ac.uk

Teléfono:None provided

Elegibilidad

Criterios de inclusión

1. Capacity to provide informed consent

2. Women with early stage (1-3) breast cancer according to the Tumor, Node, Metastasis (TNM)/American Joint Committee on Cancer (AJCC) staging system

Note: Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the trial, providing at least one of the cancers is being treated with AET, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor-positive disease

3. Aged >= 18 years old

4. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required

5. Treated with curative intent

6. Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 24 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 24 months stipulated within this criterion.

(Updated 21/10/2025, previously: Completed their hospital-based treatment (e.g., surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months. Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 12 months stipulated within this criterion).

7. Currently prescribed oral AET (tamoxifen, raloxifene, anastrozole, letrozole, exemestane)

8. Access to a mobile phone to receive SMS messages*

9. Access to a computer or smart device that can access the internet*

*Source data for these items will be either partially or completely patient self-report.

Criterios de exclusión

1. Stopped taking AET if it is clinically contraindicated according to clinical recommendation

2. Involved in a similar research trial where medication adherence is a primary outcome*,**

3. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason*

4. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*)

5. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips*

6. Taken part in the ROSETA Pilot trial.

*Source data for these items will be either partially or completely patient self-report.

**Consented to and the trial is still being delivered.

Participation in another trial will not necessarily exclude a patient from participation. CTRU should be notified of any potential conflicting trials to facilitate a review of the feasibility of co-enrolment by the CI and Trial Management Group (TMG). The review will consider the methodological impact and participant burden.

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Detalles del diseño

AsignaciónRandomized controlled 2⁴ factorial optimisation trial with an embedded Study Within a Trial

Modelo de intervenciónRandomised controlled trial

EnmascaramientoN/A

Número a inscribir512

Brazos e Intervenciones

Brazos

Intervenciones

No hay intervenciones disponibles.

Medidas de resultado

Medidas de resultado primarias

N/AN/A

To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence by using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) measure – collected at 12 months post-randomisation

Medidas de resultado secundarias

N/AN/A

Cost of SWAT intervention per participant retained at one-month.

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Sitios del ensayo

Este estudio tiene 38 sitios de ensayo

St Luke's Hospital

Bradford, Yorkshire and the Humber, GB

Reclutando

Bradford, Yorkshire and the Humber, BD5 0NA GB

St Luke's Hospital

Reclutando

York, Yorkshire and the Humber, YO31 8HE GB

York Hospital

Reclutando

Hull, Yorkshire and the Humber, HU3 2JZ GB

Hull Royal Infirmary

Reclutando

Birmingham, West Midlands, B15 2GW GB

Queen Elizabeth Hospital Birmingham

Reclutando

Woolwich, Greater London, SE18 4QH GB

Queen Elizabeth Hospital

Reclutando

London, Greater London, E9 6SR GB

Homerton University Hospital

Reclutando

Gateshead, North East, NE9 6SX GB

Queen Elizabeth Hospital Gateshead

Reclutando

Harrow, Greater London, HA1 3UJ GB

Northwick Park Hospital

Reclutando

Wythenshawe, North West, M23 9LT GB

Wythenshawe Hospital

Reclutando

Cottingham, Yorkshire and the Humber, HU16 5JQ GB

Castle Hill Hospital

Reclutando

Bradford, Yorkshire and the Humber, BD9 6RJ GB

Bradford Royal Infirmary

Reclutando

Liverpool, North West, L9 7AL GB

Aintree University Hospital

Reclutando

London, Greater London, EC1A 7BE GB

St Bartholomew's Hospital

Reclutando

Middlesborough, North East, TS4 3BW GB

The James Cook University Hospital

Reclutando

Thornton Heath, Greater London, CR7 7YE GB

Croydon University Hospital

Reclutando

Torquay, South West, TQ2 7AA GB

Torbay Hospital

Reclutando

Milton Keynes, South East, MK6 5LD GB

Milton Keynes University Hospital

Reclutando

Watford, East of England, WD18 0HB GB

Watford General Hospital

Reclutando

Lewisham, Greater London, SE13 6LH GB

University Hospital Lewisham

Reclutando

Wakefield, Yorkshire and the Humber, WF1 4DG GB

Pinderfields General Hospital

Reclutando

Prescot, North West, L35 5DR GB

Whiston Hospital

Reclutando

Southall, Greater London, UB1 3HW GB

Ealing Hospital

Reclutando

Liverpool, North West, L69 3GA GB

Royal Liverpool University Hospital

Reclutando

Leeds, LS9 7TF GB

Leeds Teaching Hospitals NHS Trust - Lead centre

Reclutando

Chesterfield, East Midlands, S44 5BL GB

Chesterfield Royal Hospital

Reclutando

Westcliff on sea, East of England, SS0 0RY GB

Southend University Hospital

Reclutando

Redhill, South East, RH1 5RH GB

East Surrey Hospital

Reclutando

Bolton, North West, BL4 0JR GB

Royal Bolton Hospital

Reclutando

Warrington, WA2 8DB GB

St Marys Hospital

Reclutando

Harlow, East of England, CM20 1QX GB

Princess Alexandra Hospital

Reclutando

Ashton-under-lyne, OL6 9RW GB

Tameside and Glossop Integrated Care NHS Foundation Trust

Reclutando

St. Helens, WA9 3DA GB

St Helens Hospital

Reclutando

Pontefract, WF8 1PL GB

Pontefract Hospital

Reclutando

Dewsbury, WF13 4HS GB

Dewsbury & District Hospital

Reclutando

Redhill, RH1 5RH GB

Surrey and Sussex Healthcare NHS Trust

Reclutando

North Shields, NE29 8NH GB

North Tyneside Hospital

Reclutando

Ashington, NE63 9JJ GB

Wansbeck Hospital

Reclutando

Hexham, NE46 1QJ GB

Hexham General Hospital

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