A pilot randomised controlled trial of Acceptance and Commitment Therapy for medication decision-making and quality of life in women with breast cancer : the ACTION trial

Graham, Christopher Darryl and Clark, Jane Elizabeth and Smith, Samuel G. (2024) A pilot randomised controlled trial of Acceptance and Commitment Therapy for medication decision-making and quality of life in women with breast cancer : the ACTION trial. Psycho-Oncology. ISSN 1099-1611 (In Press)

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Abstract

Objective Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life (ACTION). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. Methods This was a multi-site, exploratory, two-arm, individually randomized external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC+ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. Results: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomized. 71 (89.9%) women provided data at 3-months and 70 (88.6%) at 6-months. 40 women were randomized to receive UC+ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean=7.8 [SD=2.7] out of 10). Signals of effectiveness in favour of the UC+ACTION arm were observed for medication adherence (ASK-12), quality of life (WSAS), health-related quality of life (FACT-G and FACT-ES-19/23), distress (GAD-7, PHQ-9) and psychological flexibility (VQ). Conclusions: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. Trial registration: ISRCTN12027752.

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