Psychoeducational intervention for women prescribed tamoxifen
Research type
Research Study
Full title
Feasibility and Acceptability of a Psychoeducational Booklet to Support Women who have been Prescribed Tamoxifen
IRAS ID
193598
Contact name
Lyndsay Hughes
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Tamoxifen is prescribed after active treatment for breast cancer and 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 develop and pilot a psychoeducational intervention to support women who have been prescribed tamoxifen and to improve adherence rates. The intervention is likely to focus on helping women to understand the benefits of treatment and helping them to manage their side effects. The study will test the feasibility and acceptability of the intervention, as well as looking at changes in outcomes such as beliefs, perceptions, adherence and side effects. Participants will be recruited from Guy’s and St Thomas’ Trust and from four additional NHS sites. They will also be recruited from an existing database of patients who have consented to be contacted about future research. Once recruited to the study, participants will be given a series of questionnaires to complete. They will then be given the booklet for 4 weeks, after which they will complete the questionnaires again. Patients will be invited to take part in an interview to discuss how they found the intervention. Patients who declined to participate in the intervention will also be invited to an interview to discuss why they did not want to take part.The results will help us to understand how this intervention should be developed and rolled out further. An intervention like this should help to reduce distress and symptom burden in this population, as well as improving adherence and thereby potentially improving clinical outcomes. The research is funded by Breast Cancer Now.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/1205
Date of REC Opinion
22 Aug 2016
REC opinion
Further Information Favourable Opinion