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

Christopher d. Graham, Rachel Ellison, Louise h. Hall, Jane Clark, Emma Mcnaught, Sophie m. c. Green, Hollie Wilkes, Gita Robson, Ian Lorentz, Lucy Holmes, Nicky Bould, Suzanne Hartley, Jay Naik, Sarah Buckley, Charlotte Hirst, Sue Hartup, Robbie Foy, Richard d. Neal, Galina Velikova, Amanda FarrinMichelle Collinson, Samuel g. Smith

Research output: Contribution to journalArticlepeer-review

Abstract

AbstractObjectiveNon‐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.MethodsThis 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.ResultsOf 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).ConclusionsThe 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 RegistrationISRCTN12027752.
Original languageEnglish
Article numbere6349
JournalPsycho-Oncology
Volume33
Issue number5
DOIs
Publication statusPublished - 16 May 2024

Keywords

  • Medication adherence
  • breast cancer
  • Acceptance and Commitment Therapy
  • pilot
  • quality of life
  • remote delivery
  • group therapy
  • video conferencing
  • psychological flexibility
  • oncology

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