Abstract
BackgroundAdherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. This study aims to establish key trial parameters, assess the acceptability of the intervention and the extent to which it can be delivered with fidelity, and to demonstrate “proof of principle” regarding its efficacy on primary and process outcomes.MethodsThe ACTION intervention includes an individual 1:1 ACT session followed by three group sessions involving 8–10 women and two practitioner psychologists. Participants are also provided with access to a website containing evidence-based methods for self-managing side-effects. The ACT sessions were adapted during the COVID-19 pandemic to be remotely delivered via video conferencing software. To evaluate the feasibility and acceptability of this intervention, a multi-site, exploratory, two-arm, individually randomised external pilot trial with a nested qualitative study will be undertaken. Eighty women with early stage breast cancer prescribed adjuvant endocrine therapy will be randomised (1:1) to receive treatment as usual or treatment as usual plus the ACTION intervention. The planned future primary outcome is medication adherence assessed by the ASK-12 measure. Progression to a phase III RCT will be based on criteria related to recruitment and follow-up rates, acceptability to patients, competency and fidelity of delivery, and proof of principle for change in medication adherence.DiscussionThis external pilot trial will be used to ascertain the feasibility of undertaking a future phase III RCT to definitively evaluate an ACT-based intervention to support medication taking behaviour and quality of life in women with early stage breast cancer on adjuvant endocrine therapy.Trial registrationISRCTN: 12027752. Registered 24 December 2020, https://doi.org/10.1186/ISRCTN12027752
Highlights
Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress
We propose that ACT could be used to support functioning and medication adherence with women who have experienced a life-threatening event such as breast cancer, and are being asked to return to everyday life while managing treatment-related challenges
Non-adherence to adjuvant endocrine therapy (AET) is a major problem among women with breast cancer [4] and is linked with an increased risk of cancer-specific and all-cause mortality [5,6,7,8,9,10,11,12]
Summary
Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. Most breast cancers are oestrogen receptor positive (ER+) tumours. Treatment with adjuvant endocrine therapy (AET) such as Selective Oestrogen Receptor Modulators (SERMs, e.g. tamoxifen) and Aromatase Inhibitors (AIs e.g. letrozole, anastrozole, exemestane) for 5–10 years is standard care for women with ER+ tumours [3]. Low adherence and early cessation of AET are associated with an increased risk of breast cancer recurrence and all-cause mortality [5,6,7,8,9,10,11,12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
