Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.