Vadzim Khadakou

Background: Adverse events (AEs) related to cancer treatment represent a valuable source of information that can be used to adjust therapy for individual patients. The National Institutes of Health developed the Common Terminology Criteria for Adverse Events (CTCAE), a comprehensive standardized terminology for health care providers to consistently report AEs during patient visits. Mobile health technologies, in principle, also allow AEs to be self-reported by patients in between visits; however, the terminology poses challenges for them, both in selecting the correct symptom to report and in rating its severity. The National Institutes of Health developed the Patient-Reported Outcomes–CTACE as the patient-oriented companion of the CTCAE. However, it shows some weaknesses in completeness and precision when used for continuous home patient monitoring and for decision support. Objective: The aim of this paper is to propose a new terminology for reporting AEs that is easy for patients to use while also being clinically meaningful for health care providers and easily exploitable by decision support systems. Moreover, we aim to demonstrate its implementation and validation within the CAPABLE (Cancer Patients Better Life Experience) EU project. Methods: The development of the new terminology starts from the CTCAE, which includes a comprehensive list of signs and symptoms along with guidance for accurately grading their severity. Through a multistep, participatory approach involving both patients and health care providers, we reduced and adapted the AE list for patient-oriented apps. During the CAPABLE project, the proposed terminology was integrated into a mobile app and evaluated within a clinical pilot study involving 86 patients who were monitored through the app for at least 6 months, and a control cohort of 133 patients monitored using standard care practices. Results: The final terminology includes 124 AEs, 49 expressed as “present or absent,” and 77 associated with 4 description levels. A mapping between the description levels and the original CTCAE grades enables running the decision support system embedded in the CAPABLE app. The pilot study demonstrated that the majority of the patients used the symptoms reporting functionality, sharing also 24 unique AEs that are not present in the Patient-Reported Outcomes–CTCAE. Symptoms reported using the proposed terminology allowed the enactment of the clinical practice guidelines included in the CAPABLE decision support tool, triggering 11 distinct recommendations. Conclusions: The results obtained from the clinical study support our claim regarding the need for a novel terminology for the self-reporting of AEs, characterized by ease of use, completeness, and clinical meaningfulness. Finally, by mapping our terminology to the CTCAE, we demonstrated that it is possible to exploit self-reported data to trigger decision support rules consistent with clinical practice guidelines.

Background: Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life () and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives. Objective: This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions. Methods: This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time. Results: From the 59 eligible patients for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of −5.09 (95% CI −15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group (β=8.71, 95% CI 1.54‐15.88, P=.02). Conclusions: The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted.

Background: The prognosis for patients with several types of cancer has substantially improved following the introduction of immune checkpoint inhibitors, a novel type of immunotherapy. However, patients may experience symptoms both from the cancer itself and from the medication. A prototype of the eHealth tool Cancer Patients Better Life Experience (CAPABLE) was developed to facilitate symptom management, aimed at patients with melanoma and renal cell carcinoma treated with immunotherapy. Better usability of such eHealth tools can lead to improved user well-being and reduced risk of harm. It is unknown for usability evaluations whether certain usability problems would only be evident to patients whose condition closely resembles the target population, or if a broader group of patients would lead to the identification of a broader range of potential usability issues. Objective: This study aims to evaluate the CAPABLE prototype by conducting tests to assess usability, user experience, and perceived acceptability among end users, and to assess any agreements or differences in the results of our wide range of participants. Methods: This usability study was executed by interviewing participants with a melanoma or renal cell carcinoma diagnosis who have received immunotherapy and participants without direct experience with the targeted cancer types who have not received immunotherapy. Participants were asked to review the concept of the tool, perform think-aloud tasks, and complete the System Usability Scale and a Perceived Usefulness questionnaire. Usability problems were extracted from the interview data by independent coding and mapped to an eHealth Usability Problem Framework. Results: We included 21 participants in the study, aged 29 to 73 years; 13 participants who had received immunotherapy and 8 participants who had not received immunotherapy. In total, 76 usability problems were identified. A total of 22 usability problems were in the task-technology fit category of the usability framework, mostly regarding the coaching and symptom functionality of the prototype. Critical problems regarding the symptom monitoring functionality were mainly found by participants who had received immunotherapy. For 8 out of 10 statements in the Perceived Usefulness questionnaire, more than 75% of participants agreed or strongly agreed. The overall mean System Usability Scale score was 80 out of 100 (SD 11.3). Conclusions: Despite identified usability issues, participants responded positively to the Perceived Usefulness questionnaire regarding the evaluated tool. Further analysis of the usability problems indicates that it was essential to include participants who matched the target end users. Participants treated with immunotherapy, specifically with previous experience in immune-related adverse events, encountered critical problems with symptom reporting that would not have been identified if these participants were not included. For other tasks and functionalities, it seems likely that loosening the inclusion criteria would have resulted in sufficient feedback without critical missing usability issues.

BACKGROUND The prognosis for patients with several types of cancer has substantially improved following the introduction of immune checkpoint inhibitors, a novel type of immunotherapy. However, patients may experience symptoms both from the cancer itself and from the medication. A prototype of the eHealth tool Cancer Patients Better Life Experience (CAPABLE) was developed to facilitate symptom management, aimed at patients with melanoma and renal cell carcinoma treated with immunotherapy. Better usability of such eHealth tools can lead to improved user well-being and reduced risk of harm. It is unknown for usability evaluations whether certain usability problems would only be evident to patients whose condition closely resembles the target population, or if a broader group of patients would lead to the identification of a broader range of potential usability issues. OBJECTIVE This study aims to evaluate the CAPABLE prototype by conducting tests to assess usability, user experience, and perceived acceptability among end users, and to assess any agreements or differences in the results of our wide range of participants. METHODS This usability study was executed by interviewing participants with a melanoma or renal cell carcinoma diagnosis who have received immunotherapy and participants without direct experience with the targeted cancer types who have not received immunotherapy. Participants were asked to review the concept of the tool, perform think-aloud tasks, and complete the System Usability Scale and a Perceived Usefulness questionnaire. Usability problems were extracted from the interview data by independent coding and mapped to an eHealth Usability Problem Framework. RESULTS We included 21 participants in the study, aged 29 to 73 years; 13 participants who had received immunotherapy and 8 participants who had not received immunotherapy. In total, 76 usability problems were identified. A total of 22 usability problems were in the task-technology fit category of the usability framework, mostly regarding the coaching and symptom functionality of the prototype. Critical problems regarding the symptom monitoring functionality were mainly found by participants who had received immunotherapy. For 8 out of 10 statements in the Perceived Usefulness questionnaire, more than 75% of participants agreed or strongly agreed. The overall mean System Usability Scale score was 80 out of 100 (SD 11.3). CONCLUSIONS Despite identified usability issues, participants responded positively to the Perceived Usefulness questionnaire regarding the evaluated tool. Further analysis of the usability problems indicates that it was essential to include participants who matched the target end users. Participants treated with immunotherapy, specifically with previous experience in immune-related adverse events, encountered critical problems with symptom reporting that would not have been identified if these participants were not included. For other tasks and functionalities, it seems likely that loosening the inclusion criteria would have resulted in sufficient feedback without critical missing usability issues.