Green Sophie M C, Graham Christopher D, Collinson Michelle, Ow Pei Loo, Hall Louise H, French David P, Rousseau Nikki, Wilkes Hollie, Taylor Christopher, Raine Erin, Ellison Rachel, Howdon Daniel, Foy Robbie, Walwyn Rebecca E A, Clark Jane, Parbutt Catherine, Waller Jo, Buxton Jacqueline, Moore Sally J L, Velikova Galina, Farrin Amanda J, Smith Samuel G
Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9NL, UK.
Department of Psychological Sciences & Health, University of Strathclyde, Glasgow G1 1QE, UK.
Transl Behav Med. 2025 Jan 16;15(1). doi: 10.1093/tbm/ibae066.
Adherence to adjuvant endocrine therapy in women with breast cancer is low. We conducted a 24-1 fractional factorial pilot optimization trial to test four intervention components supporting medication adherence [text messages, information leaflet, acceptance and commitment therapy (ACT), self-management website], in the preparation phase of the multiphase optimization strategy. Guided by the National Institute of Health Behavior Change Consortium fidelity framework, we investigated fidelity of design, training, delivery, receipt, and enactment of four intervention components. Women prescribed adjuvant endocrine therapy (n = 52) were randomized to one of eight experimental conditions comprised of combinations of the four intervention components (ISRCTN: 10487576). We assessed fidelity using self-report data (4 months post-randomization), trial data, ACT session observations, behavior change technique (BCT) coding, and interviews with participants (n = 20) and therapists (n = 6). Design: Each intervention component targeted unique behavior change techniques with some overlap. Training: All 10 therapists passed the competency assessment. Delivery: All leaflets (27/27) and website (26/26) details were sent, and ACT procedural fidelity was high (85.1%-94.3%). A median of 32.5/41 (range 11-41) text messages were delivered, but a system error prevented some messages being sent to 22 of 28 participants. Receipt: Most participants [63.0% (ACT, leaflet) to 71.4% (text messages)] read all or at least some of the intervention components they were randomized to receive. Enactment was reported most positively for ACT. All intervention components demonstrated adequate fidelity. We have provided an exemplar for assessing fidelity using the National Institute of Health Behavior Change Consortium framework in the preparation phase of multiphase optimization strategy.
乳腺癌女性辅助内分泌治疗的依从性较低。在多阶段优化策略的准备阶段，我们进行了一项24-1析因试验性优化试验，以测试支持药物依从性的四个干预组件[短信、信息手册、接纳与承诺疗法（ACT）、自我管理网站]。以美国国立卫生研究院行为改变联盟保真度框架为指导，我们调查了四个干预组件在设计、培训、交付、接收和实施方面的保真度。接受辅助内分泌治疗的女性（n = 52）被随机分配到由四个干预组件组合而成的八个实验条件之一（国际标准随机对照试验编号：10487576）。我们使用自我报告数据（随机分组后4个月）、试验数据、ACT疗程观察、行为改变技术（BCT）编码以及对参与者（n = 20）和治疗师（n = 6）的访谈来评估保真度。设计：每个干预组件针对独特的行为改变技术，存在一些重叠。培训：所有10名治疗师通过了能力评估。交付：所有手册（27/27）和网站（26/26）的详细信息均已发送，ACT程序保真度较高（85.1%-94.3%）。短信发送的中位数为32.5/41（范围11-41），但系统错误导致28名参与者中的22名未收到部分短信。接收：大多数参与者[63.0%（ACT、手册）至71.4%（短信）]阅读了他们随机分配接收的所有或至少部分干预组件。ACT在实施方面的反馈最为积极。所有干预组件均表现出足够的保真度。我们提供了一个在多阶段优化策略准备阶段使用美国国立卫生研究院行为改变联盟框架评估保真度的范例。
