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
{"title":"针对乳腺癌女性患者用药决策和生活质量的接纳与承诺疗法随机对照试验：ACTION 试验。","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ISRCTN12027752.</p>","PeriodicalId":20779,"journal":{"name":"Psycho‐Oncology","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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.\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ISRCTN12027752.</p>\",\"PeriodicalId\":20779,\"journal\":{\"name\":\"Psycho‐Oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Psycho‐Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pon.6349\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Psycho‐Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pon.6349","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
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.
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.
期刊介绍：
Psycho-Oncology is concerned with the psychological, social, behavioral, and ethical aspects of cancer. This subspeciality addresses the two major psychological dimensions of cancer: the psychological responses of patients to cancer at all stages of the disease, and that of their families and caretakers; and the psychological, behavioral and social factors that may influence the disease process. Psycho-oncology is an area of multi-disciplinary interest and has boundaries with the major specialities in oncology: the clinical disciplines (surgery, medicine, pediatrics, radiotherapy), epidemiology, immunology, endocrinology, biology, pathology, bioethics, palliative care, rehabilitation medicine, clinical trials research and decision making, as well as psychiatry and psychology.
This international journal is published twelve times a year and will consider contributions to research of clinical and theoretical interest. Topics covered are wide-ranging and relate to the psychosocial aspects of cancer and AIDS-related tumors, including: epidemiology, quality of life, palliative and supportive care, psychiatry, psychology, sociology, social work, nursing and educational issues.
Special reviews are offered from time to time. There is a section reviewing recently published books. A society news section is available for the dissemination of information relating to meetings, conferences and other society-related topics. Summary proceedings of important national and international symposia falling within the aims of the journal are presented.
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