Evaluating the organizational benefits of remote symptom monitoring during injectable outpatient cancer treatment: The final analysis of the randomized OPTIMACURE trial.

1637 Background: Remote monitoring (RM) to assess whether patients are apt for cancer treatment is already used during standard of care (SOC) in several French centers. Optima RM includes structured phone calls by a nurse, 2-3 days before the planned administration, with the transfer of biological results 48 h before the administration, with a physician’s validation the day before administration. Cureety RM, in addition to preparing visit, also monitors symptoms between cures. We aimed to evaluate the organizational benefit of Cureety RM compared to Optima-like RM in patients initiating outpatient injectable cancer treatments. Methods: OPTIMACURE was designed as a multicentric, randomized, open-label trial to compare Cureety RM versus Optima-like RM. Patients aged ³18 years, starting an injectable cancer treatment, and capable of using a RM tool were eligible. Patients with dysphonia/difficulties with oral communication were not eligible. Enrolled patients were randomly allocated (2:1) to either Cureety RM or to SOC (with Optima-like RM). Randomization was stratified by type of cancer treatment, ECOG PS, frequency of treatment, and center. Only centers using Optima-like RM participated in the trial. The primary objective was to assess the effectiveness of adding Cureety RM to usual care, in terms of the number of outgoing calls, overall and by reason (preparing visits or for toxicity), within the first 2 months. Secondary outcomes included safety, toxicity-free survival (TFS), and hospitalizations. Results: Between April and August 2024, 192 patients were allocated: 127 (66%) to Cureety RM and 65 (34%) to SOC (with Optima-like RM). The trial population was mainly female (73%) and with an ECOG PS 0-1 (96%). Most were being treated with chemotherapy (98%) and less frequently than every 2 weeks (61%). The demographic and disease characteristics were similar in the groups. The mean number of outgoing calls were fewer with Cureety RM, 2.53 (SD: 2.21) versus 3.77 (SD: 2.45). The difference of least-squares means was significantly different in the groups: -1.25 (95% CI: -1.91 to -0.59), p<0.0001. The number of outgoing calls for preparing visit were significantly fewer with Cureety RM, 0.43 (SD: 0.82) versus 3.09 (SD: 2.18), p<0.001. While there were significantly more outgoing calls for toxicity with Cureety RM, 1.68 (SD: 1.89) versus 0.20 (SD: 0.71), p<0.001. No adverse events (AEs) related to RM were reported. The median TFS was significantly shorter with Cureety RM, 10 days versus not reached: driven by early detection of grade ≤4 AEs. The number of hospitalizations was similar in the groups. Conclusions: Implementing Cureety RM during injectable cancer treatment had an organizational benefit by reducing the number of outgoing calls. More precisely, reducing the outcalls for preparing visit while increasing those for AEs. Clinical trial information: NCT06371911 .