'Cancer Patients Better Life Experience'

Study Overview
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Brief Summary
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The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.

Detailed Description
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This is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ICI therapy. The explorative cohort receives the CAPABLE smartphone application and a multi-sensorial smartwatch. Patients will be asked to use the system for minimum of three to maximum of six months after enrolment. Questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (T0), three months (T1) and six months (T2). Results of this interventional study will be compared with a historical cohort consisting of melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the CAPABLE app).

Official Title
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Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'

Conditions
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Melanoma

Intervention / Treatment
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* Device: Cancer Patients Better Life Experience (CAPABLE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Sufficient understanding of the Dutch language Participants or their caregiver can use a smartphone (upon patient's consent) Histologically confirmed stage III or IV melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines. Exclusion Criteria: Included in a clinical trial >12 months on active treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAPABLE cohort<br>Group that receives the CAPABLE application during treatment | Device: Cancer Patients Better Life Experience (CAPABLE)<br>* The CAPABLE system serves three main goals for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing. These are available to the patient as a smartphone application that is connected to a smartwatch to monitor activity, blood pressure, sleep and heart rate. Patients are able to report symptoms experienced from the treatment and are eligible to do interventions such as mindfulness or yoga. Patients will receive the CAPABLE application and smartwatch for a minimum 3 to a maximum of 6 months after start treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30) | Fatigue is measured on a score from 0-100, the lower the score the less fatigue a patient has | Baseline, month 3, month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life and QALY's between baseline and 3 and 6 months, as measured by The EuroQoL-5D (EQ-5D-5L). | The EQ-5D is a standardised 5-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It contains a visual analogue scale, with a score from 0 to 100, the higher the score, the better the outcome. Furthermore, it measures utility scores that can be linked to a country index and be further used in cost-effectiveness analysis. | Baseline, month 3, month 6 | 
| Change in health-related quality of life and physical symptoms between baseline and 3 and 6 months, as measured by the EORTC QLQ-C30 | Funtional domains: scale from 0 to 100, the higher the score, the better the functioning. Symptoms: on a scale from 0 to 100, the higher the score, the worse the symptom | Baseline, month 3, month 6 | 
| Change in melanoma specific quality of life between baseline and 3 and 6 months, as measured by the FACT-M | Of the FACT-M, we use the Melanoma Subscale (scale 0 to 64) and the Melanoma Surgery Subscale (scale 0 to 32), items specific to quality of life in melanoma patients. High scores show a high quality of life. The higher the score the better the quality of life is. | Baseline, month 3, month 6 | 
| Change in patient reported immunotherapy-related toxicity between baseline and 3 and 6 months, as measured by a self-developed questionnaire using EORTC item bank items | We identified, based on literature and expert opinion, 19 symptoms and created a symptom list based on items of the EORTC item Library. Scale from 0 to 100, the higher the score, the worse the symptom. | Baseline, month 3, month 6 | 
| Change in psychological distress between baseline and 6 months, as measured by the Hospital Anxiety and Depression Scale (HADS). | The HADS is a 14-itemquestionnaire, assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score. The higher the score, the worse the depression and/or anxiety is. | Baseline, month 6 | 
| Change in information satisfaction/needs between baseline and 6 months, as measured by the EORTC QLQ-INFO25 | Measures different domains of satisfaction with delivered information. Scale of 0 to 100, the higher the score the higher the satisfaction/delivered information. | Baseline, month 6 | 
| Recruitment rate | The ratio of patients that are included in the study out of the patients eligible for study participation | Through study completion, an average of 6 months | 
| Patient compliance | The ratio of patients completing the questionnaire and using the CAPABLE app, out of the included patients | Through study completion, an average of 6 months | 
| Usability/user experience as measured by The System Usability Scale (SUS) | The System Usability Scale (SUS) consists of a 10 item questionnaire with five response options for respondents. The participant's scores are converted to original scores of 0-40 to 0-100. Scores should be considered only in terms of their percentile ranking. | Baseline | 
| Usability/user experience as measured by PAtient Trust Assessment Tool (PATAT) | Measured on a Likert-scale from 1 to 5. A score higher than 3 is considered trust in telemedicine. Reported as the percentage that has a score higher than 3 and the percentage that scored equal or below 3. | Month 3 | 
| Usability/user experience as measured by the User Version of the Mobile Application Rating Scale (uMARS) | The uMARS is a20-item measure that includes 4 objective quality subscales-engagement, functionality, aesthetics, and information quality-and 1 subjective quality subscale. The higher the score the better the outcomes. | Month 6 |