A Digital Solution to Support Medication Adherence and Self-Management in Patients with Cancer: SAMSON Pilot Randomized Controlled Trial (Preprint)

Abstract

Medication non-adherence is a serious problem in cancer with potential impact on patients’ health outcomes and healthcare costs. Technology-based medication adherence (MA) interventions are increasingly introduced, yet their evidence of quality and effectiveness is poor.

This study aimed to test the acceptability, feasibility, and potential effects of SAMSON, a digital solution designed to support MA and self-management in cancer.

This was a two-arm, unblinded, 12-week, pragmatic pilot randomized controlled trial (RCT). Adults who started oral cancer medicines for haematological malignancies within the last 12 months were recruited from a metropolitan specialised hospital. Participants were randomized 1:1 to either the SAMSON solution or the control arm to receive usual care. The SAMSON solution included a smartphone app which allows prompting individually tailored phone alerts and real-time self-care advice, a web-based dashboard for healthcare professionals (HCPs) to monitor patients’ adherence and symptoms, alongside motivational interviewing (MI) teleconsultations delivered by oncology nurses and pharmacists scheduled after recruitment and at weeks 1, 4, 8 and 12, to support patient adherence and side-effect self-management. 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-depression-and symptoms, and quality of life, measured at baseline and 12 weeks between the two arms. Data retrieved from the SAMSON app on the tasks completed by patients were used for analysis.

Thirty-three patients (78.6% of those who were approached) consented to participate in the trial. Of those, 31 (93.7%) completed baseline surveys and were randomised to SAMSON (n=15) and control arms (n=16). Twenty-eight patients (90.3%) completed week-12 surveys (12 SAMSON and 16 control). Overall, patients rated SAMSON solution as highly acceptable (13/15; 86.7% app usage and 14/15; 93.3% MI teleconsultation delivery). They reported that SAMSON was easy-to-use (10/12; 83.3%) 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 (70.7% of scheduled tasks). Most patients (10/12; 83.3%) completed all five scheduled consultations. All study feasibility measures were higher than the predefined upper thresholds, except the rate of patients’ responses to medication reminders.

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 SAMSON solution based on participants’ feedback, conducting a large-scale RCT to evaluate its clinical and economic effectiveness, and exploring potential commercialisation.

ACTRN12623000472673

RR2-10.1136/bmjopen-2023-079122