The Yorkshire Cancer Research ACTION Pilot Trial
Research type
Research Study
Full title
The Yorkshire Cancer Research ACTION Pilot Trial: An ACT-based intervention for women with breast cancer to support wellbeing and hormone therapy medication decisions.
IRAS ID
276424
Contact name
Sam Smith
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN12027752
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Women with oestrogen receptor positive breast cancer who have finished their primary, hospital-based treatment (e.g. chemotherapy/surgery) and have been prescribed adjuvant Hormone Therapy (HT) often suffer unpleasant side effects and a reduced quality of life. They can also find that support is lacking at this stage of their cancer journey. This can cause women not to take their medication as frequently as prescribed, which therefore increases their risk of a cancer reoccurrence and mortality. A psychological intervention has been developed based on Acceptance and Commitment Therapy (ACT). There is a growing evidence base demonstrating that ACT can improve outcomes (functioning, quality of life, mood) in chronic disease and, in particular, chronic pain contexts. Based on the preceding rationale, we co-developed the ACTION intervention together with breast cancer patients and clinicians working in oncology to improve adherence to HTs (and improve quality of life) in women with breast cancer. The intervention will consist of one individual session of ACT, followed by three group sessions delivered by Clinical Psychologists.A case study proceeded this pilot, which identified any issues with the training, delivery, and evaluation of the intervention by carrying out a full cycle of the intervention (recruitment, delivery, data collection) at a single site. Feedback on the acceptability and feasibility of the intervention from participants (patients) and healthcare professionals involved in the set-up and delivery of the intervention will inform this study. 80 participants will be randomised to receive either treatment as usual (TAU) or treatment as usual plus the ACTION intervention, this forms part of a Yorkshire Cancer Research funded programme. Assuming the pilot study is successful and the therapy acceptable to participants and therpists, the next phase will be a large scale phase III randomised controlled trial.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
20/YH/0104
Date of REC Opinion
3 Dec 2020
REC opinion
Further Information Favourable Opinion