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

• Published in: Psycho-oncology (Chichester, England) England), 2024-05, Vol.33 (5), p.e6349-n/a
• Main Authors: Graham, Christopher D., Ellison, Rachel, Hall, Louise H., Clark, Jane, McNaught, Emma, Green, Sophie M. C., Wilkes, Hollie, Robson, Gita, Lorentz, Ian, Holmes, Lucy, Bould, Nicky, Hartley, Suzanne, Naik, Jay, Buckley, Sarah, Hirst, Charlotte, Hartup, Sue, Foy, Robbie, Neal, Richard D., Velikova, Galina, Farrin, Amanda, Collinson, Michelle, Smith, Samuel G.
• Format: Article
• Language: English
• Subjects: Acceptance; Acceptance and commitment therapy; Acceptance and Commitment Therapy - methods; Action; Adherence; Adjustment; Adult; Aged; Antineoplastic Agents, Hormonal - therapeutic use; Anxiety disorders; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - psychology; Breast Neoplasms - therapy; Chemotherapy, Adjuvant - psychology; Clinical assessment; Clinical psychologists; Decision Making; Drugs; Endocrine therapy; Feasibility; Female; Functional assessment; Generalized anxiety disorder; group therapy; Humans; Intervention; medication adherence; Medication Adherence - psychology; Mental health; Middle Aged; oncology; pilot; Pilot Projects; Psychological distress; Psychological flexibility; Quality of Life; Questionnaires; remote delivery; Side effects; video conferencing; Websites; Women; Womens health
• ISSN: 1057-9249; 1099-1611; 1099-1611
• DOI: 10.1002/pon.6349

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 intervention (ACTION) to enhance medication decision‐making and quality of life (QoL). 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 randomised 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%) randomised. 71 (89.9%) women provided data at 3‐month and 70 (88.6%) at 6‐month 40 women were randomised 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 (Adherence Starts with Knowledge questionnaire‐12), QoL (work and social adjustment scale), health‐related QoL (functional assessment of cancer therapy[FACT] general and FACT‐ES‐19/23), distress (generalised anxiety disorder ‐7, patient health questionnaire‐9) and psychological flexibility (valuing questionnaire). 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.