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 Farrin; Michelle Collinson; Samuel G. Smith

doi:10.1002/pon.6349

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

Psychology

Research output: Contribution to journal › Article › peer-review

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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 language	English
Article number	e6349
Number of pages	13
Journal	Psycho-Oncology
Volume	33
Issue number	5
DOIs	https://doi.org/10.1002/pon.6349
Publication status	Published - 16 May 2024

Funding

We thank the research sites for their support in delivering the trial, and the patients who kindly agreed to take part. For the purpose of open access, the author(s) has applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising. The trial was supported by funding from Yorkshire Cancer Research (L417) (PIs: Smith and Graham). This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr. Samuel Smith NIHR300588. Smith also acknowledges funding support from a Yorkshire Cancer Research University Academic Fellowship. Foy, Farrin, and Collinson acknowledge funding support from NIHR. The views expressed in this publication are those\u00A0of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data, and in the writing of this\u00A0manuscript. We extend our thanks to members of the Trial Steering Committee: Professor Cindy Cooper (University of Sheffield), Professor Maddy Arden (Sheffield Hallam University), Professor Roshan\u00A0Das Nair (previously University of Nottingham), Nyree Salter (Patient contributor), Michaela Kneafsey (Patient contributor). We thank the research sites for their support in delivering the trial, and the patients who kindly agreed to take part. For the purpose of open access, the author(s) has applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising. The trial was supported by funding from Yorkshire Cancer Research (L417) (PIs: Smith and Graham). This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr. Samuel Smith NIHR300588. Smith also acknowledges funding support from a Yorkshire Cancer Research University Academic Fellowship. Foy, Farrin, and Collinson acknowledge funding support from NIHR. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data, and in the writing of this manuscript. We extend our thanks to members of the Trial Steering Committee: Professor Cindy Cooper (University of Sheffield), Professor Maddy Arden (Sheffield Hallam University), Professor Roshan Das Nair (previously University of Nottingham), Nyree Salter (Patient contributor), Michaela Kneafsey (Patient contributor).

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/pon.6349Licence: CC BY 4.0

Graham-etal-PO-2024-A-pilot-randomised-controlled-trial-of-Acceptance-and-Commitment-Therapy-for-medicationFinal published version, 711 KBLicence: CC BY 4.0

Cite this

Graham, C. D., Ellison, R., Hall, L. H., Clark, J., Mcnaught, E., Green, S. M. C., Wilkes, H., Robson, G., Lorentz, I., Holmes, L., Bould, N., Hartley, S., Naik, J., Buckley, S., Hirst, C., Hartup, S., Foy, R., Neal, R. D., Velikova, G., ... Smith, S. 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, 33(5), Article e6349. https://doi.org/10.1002/pon.6349

@article{eaaba8fa9e46432d9fb6c20552027a25,

title = "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",

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.",

keywords = "medication adherence, breast cancer, Acceptance and Commitment Therapy, pilot, quality of life, remote delivery, group therapy, video conferencing, psychological flexibility, oncology",

author = "Graham, {Christopher D.} and Rachel Ellison and Hall, {Louise H.} and Jane Clark and Emma Mcnaught and Green, {Sophie M. C.} and Hollie Wilkes and Gita Robson and Ian Lorentz and Lucy Holmes and Nicky Bould and Suzanne Hartley and Jay Naik and Sarah Buckley and Charlotte Hirst and Sue Hartup and Robbie Foy and Neal, {Richard D.} and Galina Velikova and Amanda Farrin and Michelle Collinson and Smith, {Samuel G.}",

year = "2024",

month = may,

day = "16",

doi = "10.1002/pon.6349",

language = "English",

volume = "33",

journal = "Psycho-Oncology",

issn = "1057-9249",

publisher = "John Wiley and Sons Ltd",

number = "5",

}

Graham, CD, Ellison, R, Hall, LH, Clark, J, Mcnaught, E, Green, SMC, Wilkes, H, Robson, G, Lorentz, I, Holmes, L, Bould, N, Hartley, S, Naik, J, Buckley, S, Hirst, C, Hartup, S, Foy, R, Neal, RD, Velikova, G, Farrin, A, Collinson, M & Smith, SG 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, vol. 33, no. 5, e6349. https://doi.org/10.1002/pon.6349

TY - JOUR

T1 - A pilot randomised controlled trial of Acceptance and Commitment Therapy for medication decision-making and quality of life in women with breast cancer

T2 - the ACTION trial

AU - Graham, Christopher D.

AU - Ellison, Rachel

AU - Hall, Louise H.

AU - Clark, Jane

AU - Mcnaught, Emma

AU - Green, Sophie M. C.

AU - Wilkes, Hollie

AU - Robson, Gita

AU - Lorentz, Ian

AU - Holmes, Lucy

AU - Bould, Nicky

AU - Hartley, Suzanne

AU - Naik, Jay

AU - Buckley, Sarah

AU - Hirst, Charlotte

AU - Hartup, Sue

AU - Foy, Robbie

AU - Neal, Richard D.

AU - Velikova, Galina

AU - Farrin, Amanda

AU - Collinson, Michelle

AU - Smith, Samuel G.

PY - 2024/5/16

Y1 - 2024/5/16

N2 - 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.

AB - 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.

KW - medication adherence

KW - breast cancer

KW - Acceptance and Commitment Therapy

KW - pilot

KW - quality of life

KW - remote delivery

KW - group therapy

KW - video conferencing

KW - psychological flexibility

KW - oncology

UR - https://onlinelibrary.wiley.com/doi/full/10.1002/pon.6349

U2 - 10.1002/pon.6349

DO - 10.1002/pon.6349

M3 - Article

SN - 1057-9249

VL - 33

JO - Psycho-Oncology

JF - Psycho-Oncology

IS - 5

M1 - e6349

ER -

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

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Keywords

UN SDGs

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