一项针对女性乳腺癌患者药物决策和生活质量的接受与承诺疗法的初步随机对照试验：ACTION 试验。

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.

机构信息

Department of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.

Department of Health Sciences, University of York, York, UK.

出版信息

Psychooncology. 2024 May;33(5):e6349. doi: 10.1002/pon.6349.

DOI:10.1002/pon.6349

PMID:38752788

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 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.

摘要

目的

乳腺癌患者不遵医嘱服用辅助内分泌治疗（AET）的情况很常见，这与药物副作用和痛苦有关。我们共同设计了一种接受和承诺疗法干预（ACTION），以增强药物决策和生活质量（QoL）。我们对 ACTION 进行了一项试点试验，以了解 III 期试验的可行性，并检验干预措施的可接受性。

方法

这是一项多地点、探索性、两臂、个体随机对照的外部试点试验。接受 AET 治疗的早期乳腺癌女性被随机分为接受常规护理（UC）或 UC+ACTION。ACTION 干预措施包括远程提供一对一的 ACT 会议，然后由临床心理学家提供三次小组会议，以及一个包含自我管理副作用想法的网站。

结果

在筛选出的 480 名符合条件的女性中，有 260 名（54.2%）被接触，其中 79 名（30.4%）被随机分组。71 名（89.9%）女性在 3 个月时提供了数据，70 名（88.6%）在 6 个月时提供了数据。40 名女性被随机分配到 UC+ACTION 组，其中 32 名（80.0%）完成了干预。大多数（75.0%）至少访问过一次网站。ACTION 得到了参与者的认可（Borkovec 和 Nau 量表：平均为 7.8 [SD=2.7]，满分 10 分）。UC+ACTION 组在药物依从性（知识问卷-12 分）、生活质量（工作和社会调整量表）、健康相关生活质量（癌症治疗功能评估[FACT]一般和 FACT-ES-19/23）、痛苦（广泛性焦虑障碍-7 分，患者健康问卷-9 分）和心理灵活性（重视问卷）方面表现出有希望的有效性信号。