e-path study
Research type
Research Study
Full title
Randomised controlled trial of an app-based digital intervention to support breast cancer survivors prescribed hormone therapy (e-path study)
IRAS ID
244500
Contact name
Lyndsay Hughes
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 5 months, 29 days
Research summary
Hormone therapy (HT) is prescribed to breast cancer survivors after they have completed primary treatment. It can significantly reduce the risk of breast cancer recurrence and mortality. However, many women do not take their treatment as prescribed, which is known as non-adherence. This leads to significantly increased risk of recurrence and mortality. Despite sub-optimal levels of adherence and the importance of adherence in clinical outcomes, no studies have attempted to improve adherence to tamoxifen. This study will test a digital intervention which has been developed and piloted as part of a previous study (16/LO/1205). The results from the pilot study showed the intervention was acceptable, and that it had the potential to improve adherence. The intervention aims to; (1) provide information on how HT works and why women have been prescribed it, (2) help women develop strategies to remember to take HT, (3) address any concerns associated with HT, and (4) help women to manage their side effects. The main outcome will be adherence and persistence and there will be several secondary psychosocial outcomes, such as quality of life and beliefs about medication. 2000 patients across a number of NHS sites will be recruited to phase 1, which is a large questionnaire study to investigate predictors of non-adherence and uptake of the intervention. From there, 220 eligible patients will be invited into phase 2 and randomised to the intervention or wait-list control group. The intervention will last 9 weeks. Patients in the wait list control group will receive access to the intervention at 12 months. Participants will complete questionnaires at baseline and at 9 weeks, 6 months and 12 months post randomisation. The results will establish the efficacy of this intervention at improving adherence and supporting patients with the treatment.
The study is funded by Breast Cancer Now.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1674
Date of REC Opinion
18 Oct 2018
REC opinion
Favourable Opinion