'Cancer Patients Better Life Experience'
- Conditions
- Melanoma
- Registration Number
- NCT05827289
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- >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.
- Included in a clinical trial
- >12 months on active treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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) Baseline, month 3, month 6 Fatigue is measured on a score from 0-100, the lower the score the less fatigue a patient has
- Secondary Outcome Measures
Name Time Method 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). Baseline, month 3, month 6 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.
Patient compliance Through study completion, an average of 6 months The ratio of patients completing the questionnaire and using the CAPABLE app, out of the included patients
Change in melanoma specific quality of life between baseline and 3 and 6 months, as measured by the FACT-M Baseline, month 3, month 6 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.
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 Baseline, month 3, month 6 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.
Change in psychological distress between baseline and 6 months, as measured by the Hospital Anxiety and Depression Scale (HADS). Baseline, month 6 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.
Change in information satisfaction/needs between baseline and 6 months, as measured by the EORTC QLQ-INFO25 Baseline, month 6 Measures different domains of satisfaction with delivered information. Scale of 0 to 100, the higher the score the higher the satisfaction/delivered information.
Usability/user experience as measured by The System Usability Scale (SUS) Baseline 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.
Usability/user experience as measured by the User Version of the Mobile Application Rating Scale (uMARS) Month 6 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.
Recruitment rate Through study completion, an average of 6 months The ratio of patients that are included in the study out of the patients eligible for study participation
Usability/user experience as measured by PAtient Trust Assessment Tool (PATAT) Month 3 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.
Change in health-related quality of life and physical symptoms between baseline and 3 and 6 months, as measured by the EORTC QLQ-C30 Baseline, month 3, month 6 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
Trial Locations
- Locations (1)
Netherlands Cancer Institute
🇳🇱Amsterdam, North Holland, Netherlands
Netherlands Cancer Institute🇳🇱Amsterdam, North Holland, NetherlandsItske FratermanContact+31205122036i.fraterman@nki.nl