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Abstract BackgroundPatients 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. ObjectiveThis 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. MethodsThis 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. ResultsFrom 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=P ConclusionsThe 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.

BackgroundThe 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. ObjectiveThis 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. MethodsThis 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. ResultsWe 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). ConclusionsDespite 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.

BackgroundSince treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed. ObjectiveIn this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients’ acceptance and usability of using CAPABLE. MethodsThis prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters. ResultsStudy inclusion started in April 2023 and is currently ongoing. ConclusionsThis pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22). Trial RegistrationClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID)DERR1-10.2196/49252

Purpose Execute a phase I/II feasibility study with TIL therapy in metastatic melanoma at the Netherlands Cancer Institute, with the goal to assess feasibility and potential value of a randomized phase III trial.Experimental Ten patients were treated with TIL therapy. Infusion products and peripheral blood samples were phenotypically characterized and neoantigen reactivity was assessed. Here, we present long-term clinical outcome and translational data on neoantigen reactivity of the T cell products.Results Five out of 10 patients, who were all anti-PD-1 naïve at time of treatment, showed an objective clinical response, including two patients with a complete response that are both ongoing for more than 7 years. Immune monitoring demonstrated that neoantigen-specific T cells were detectable in TIL infusion products from three out of three patients analyzed. For six out of the nine neoantigen-specific T cell responses detected in these TIL products, T cell response magnitude increased significantly in the peripheral blood compartment after therapy, and neoantigen-specific T cells were detectable for up to 3 years after TIL infusion.Conclusion The clinical results from this study confirm the robustness of TIL therapy in metastatic melanoma and the potential role of neoantigen-specific T cell reactivity. In addition, the data from this study supported the rationale to initiate an ongoing multicenter phase III TIL trial.