Wen Kuang-Yi, Palmisiano Neil, Smith Rita, Slamon Rachel, Keiffer Gina, Fidler Christian, Kasner Margaret, Wilde Lindsay
Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, 19107, USA.
Rutgers Cancer Institute, Rutgers University, New Brunswick, NJ, USA.
Support Care Cancer. 2025 May 24;33(6):498. doi: 10.1007/s00520-025-09537-z.
Patients undergoing tyrosine kinase inhibitor (TKI) therapy for chronic myeloid leukemia (CML) often face challenges with adherence, despite the efficacy of the treatment. Theory-guided and evidence-informed interventions addressing psychosocial and adherence barriers are critical for promoting adherence. Using a mixed-method approach, the pilot study developed and evaluated the feasibility and potential impact of an intervention "txt4TKI," to support medication and symptom management among CML patients undergoing TKI therapy.
Guided by the Necessity and Concerns framework, the study comprised two phases: Phase 1 involved qualitative patient needs assessment interviews informing intervention design. Phase 2 was a single-arm pilot study conducted for 6 months. The objectives of Phase 2 were to assess the feasibility and acceptability of the txt4 TKI intervention, examining enrollment and retention rates, intervention utilization, patient satisfaction, and changes in TKI medication adherence, psychosocial and symptom factors, from baseline to the 6-month follow-up. The intervention integrates a smart pill bottle activated with light, chimes to remind medication taking and three proactive text messages per week addressing clinical importance of TKI, symptom, lifestyle, and distress management as well as a biweekly toxicity assessment with tailored management feedback. Adherence was also objectively measured by the smart pill bottle and psychosocial survey was repeatedly assessed at 3- and 6-month.
The intervention, developed iteratively and theoretically through patient-centered inputs (n = 10) and evidence-based information during Phase 1, integrates knowledge on CML, TKI therapy, self-care symptom management, emotional support, and healthy lifestyle recommendations. In Phase 2, 20 out of 30 eligible patients (67% consent rate), with a mean age of 55.3, 60% females and 65% Non-White participants, were enrolled. Fifty-five percent have been taking their medication for 1-3 years and 50% were taking Dasatinib. A high satisfaction and engagement rate of 90% with an 85% retention rate were observed. While medication self-efficacy significantly improved from baseline to 6 months, the adherence rate to TKI was slightly decreased over time. Post-intervention interviews indicated that participants found the intervention user-friendly, providing valuable information and emotional support, but adjusting the timing and content of interventions to tailor to different stages of therapy might better support sustained adherence.
The txt4 TKI intervention using interactive text messaging and a smart pill bottle, feasible, and acceptable, demonstrated an increase in medication self-efficacy, an important aspect of medication adherence behaviors. Further research is needed to explore factors that influence the promotion and maintenance of adherence behaviors.
尽管酪氨酸激酶抑制剂（TKI）治疗慢性粒细胞白血病（CML）疗效显著，但接受该治疗的患者在坚持治疗方面常常面临挑战。针对心理社会和坚持治疗障碍的理论指导及循证干预措施对于促进坚持治疗至关重要。本试点研究采用混合方法，开发并评估了一种名为“txt4TKI”的干预措施，以支持接受TKI治疗的CML患者进行药物治疗和症状管理。
在必要性和关注点框架的指导下，该研究包括两个阶段：第一阶段涉及定性的患者需求评估访谈，为干预措施设计提供信息。第二阶段是一项为期6个月的单臂试点研究。第二阶段的目标是评估txt4TKI干预措施的可行性和可接受性，检查入组率和留存率、干预措施的使用情况、患者满意度，以及从基线到6个月随访期间TKI药物治疗依从性、心理社会和症状因素的变化。该干预措施整合了一个通过灯光激活的智能药瓶，有提示音提醒服药，每周发送三条主动短信，内容涉及TKI的临床重要性、症状、生活方式和痛苦管理，以及每两周进行一次毒性评估并提供量身定制的管理反馈。还通过智能药瓶客观测量依从性，并在3个月和6个月时反复进行心理社会调查。
在第一阶段，通过以患者为中心的投入（n = 10）和循证信息，对干预措施进行了迭代式和理论性开发，该干预措施整合了关于CML、TKI治疗、自我护理症状管理、情感支持和健康生活方式建议的知识。在第二阶段，30名符合条件的患者中有20名（同意率67%）入组，平均年龄55.3岁，60%为女性，65%为非白人参与者。55%的患者已服药1至3年，50%的患者服用达沙替尼。观察到满意度和参与率高达90%，留存率为85%。虽然从基线到6个月药物自我效能显著提高，但TKI的依从率随时间略有下降。干预后访谈表明，参与者发现该干预措施用户友好，提供了有价值的信息和情感支持，但调整干预措施的时间和内容以适应治疗的不同阶段可能会更好地支持持续的依从性。
使用交互式短信和智能药瓶的txt4TKI干预措施可行且可接受，显示出药物自我效能有所提高，这是药物依从行为的一个重要方面。需要进一步研究以探索影响依从行为促进和维持的因素。
