Abstract
BACKGROUND: Medication nonadherence is a serious problem in cancer, potentially impacts patients' health outcomes and health care costs. Although technology-based medication adherence (MA) interventions have emerged, evidence supporting their quality and effectiveness remains limited. OBJECTIVE: This study tested the acceptability, feasibility, and potential effects of Safety and Adherence to Medications and Self-care Advice in Oncology (SAMSON), a digital solution designed to support MA and self-management in cancer. METHODS: A 12-week, 2-arm, unblinded, pragmatic pilot randomized controlled trial was conducted. Adults with hematological malignancies who started oral cancer medicines within the last 12 months were recruited from a metropolitan specialized hospital and randomized 1:1 to SAMSON or control (usual care). The SAMSON solution included a smartphone app with tailored alerts and real-time self-care advice, a web-based dashboard for health care professionals (HCPs) to monitor patients' adherence and symptoms, and motivational interviewing (MI) teleconsultations delivered by oncology nurses and pharmacists at baseline and weeks 1, 4, 8, and 12. Primary outcomes were the patients' acceptance of SAMSON, measured by the Unified Theory of Acceptance and Use of Technology at 12 weeks, and study feasibility, measured by predefined rates of recruitment, randomization, retention, intervention adherence, and outcome assessment completion. Secondary outcomes were comparison of MA and clinical self-assessments through online questionnaires, including adherence, toxicity self-management, anxiety and depression symptoms, and quality of life, measured at baseline and 12 weeks between the 2 arms. Data retrieved from the SAMSON app (Swinburne University of Technology) was analysed for task completion. RESULTS: A total of 33 patients (79% of those who were approached) consented to participate in the trial. Of those, 31/33 (94%) completed baseline surveys and were randomized to SAMSON (15/31) and control arms (16/31). Of 31 patients, 28 (90%) completed the 12-week surveys (12 SAMSON and 16 control). Overall, patients rated the SAMSON solution as highly acceptable (13/15, 87% app usage; 14/15, 93% MI teleconsultation delivery). They reported that SAMSON was easy to use (10/12, 83%) and helpful in improving their MA (6/12, 50%). All study HCPs reported the SAMSON solution was helpful in supporting patients' MA. Patients completed an average of 99 tasks over the 12-week study period (71% of scheduled tasks). Most patients (10/12, 83%) completed all 5 scheduled consultations. All study feasibility measures were higher than the predefined upper thresholds, except the rate of patients' responses to medication reminders. CONCLUSIONS: The results demonstrated that the SAMSON solution is acceptable, usable, and useful for oncology HCPs and patients with cancer. The SAMSON solution is feasible in real-life oncology settings. Our next steps involve refining the SAMSON solution based on participants' feedback, conducting a large-scale randomized controlled trial to evaluate its clinical and economic effectiveness, and exploring potential commercialization. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000472673; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385728. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2023-079122.