Feasibility and first results of digital patient-reported outcomes measures (PROMs) data collection for patients with localized prostate cancer at diagnosis.
Authors: Geraldine Pignot, Marion Picini, Patricia Marino, Naji Salem, Stanislas Rybikowski, Thomas Maubon, Sami Fakhfakh, Nicolas Branger, Mathilde Guerin, Cecile Vicier, Jochen Walz, Gwenaelle Gravis
Journal: Journal of Clinical Oncology (2021)

12071 Background: Patient-reported outcomes measures (PROMs) allow optimal evaluation of side effects of treatments and their impact on quality of life. In localized prostate cancer, these PROMs are an interesting tool for comparing the impact of different treatments. The objective of our study was to evaluate the feasibility of a PROMs assessment using a digital application and to analyze the functional outcomes at 1, 3 and 6 months for urinary continence and sexuality. Methods: Since May 2019, patients treated for localized prostate cancer in our center, regardless of the treatment choice, have been offered inclusion in a digital prospective program. PROMs questionnaires (EPIC-26, Q50 PR25, EQ- 5D and PRO-CTCAE) were sent via a dedicated digital application, before treatment (T0), at 1 month (M1), 3 months (M3), 6 months (M6) and 1 year. Program adherence was assessed by the proportion of patients who logged in to the app and the proportion of patients who responded to questionnaires. The first results, at T0, M1, M3 and M6, were analyzed for urinary continence and erectile function, and compared according to age, baseline characteristics and treatment strategy. Results: Between May 2019 and December 2020, 324 patients were included in the program. Thirty patients (9.3%) did not log into the app and 29 (8.9%) logged in but did not respond to the PROMs questionnaires sent out. The adherence rate was not related to age or treatment strategy. In the end, 265 patients (81.8%) answered the PROMs questionnaires, including 185 patients treated by surgery, 11 by brachytherapy, 15 by radiotherapy, 24 by radio-hormonotherapy and 30 under active surveillance. Before treatment (T0), 15.8% (42/265) of patients reported having urine leakage (at least once a week) and 41.5% (110/265) having poor or no erections. At M1, M3, and M6, the incontinence rate was 50.8%, 37.8% and 28.7% respectively, and the erectile dysfunction rate was 73.3%, 74.1% and 70.1% respectively. Sexual recovery was strongly associated with baseline erectile function (T0); patients with good sexual function at diagnosis had an erectile dysfunction rate of 53.8% at 1 month (versus 89.9% for patients with pre-existing sexual dysfunction, p &lt; 0.001), and 51.1% at 3 months (versus 84.0%, p &lt; 0.001). Age was not associated with continence or sexuality recovery. Patients treated with surgery had significantly poorer functional outcomes in terms of continence (p &lt; 0.001) and sexuality (p &lt; 0.001) compared to other strategies. Conclusions: The implementation of PROMs using a digital application achieves an adherence rate of over 80%. The incontinence rate decreases rapidly over the 6 months following treatment, while erectile dysfunction rate remains stable over time. Early side effects are more common after surgery, requiring appropriate supportive strategies.