advanced melanoma Head-neck cancer non small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with advanced head and neck cancer starting concurrent cisplatin-based chemo-radiation therapy or bioradiationtherapy - Patients with stage III or stage IV melanoma who start with either immunotherapy (pembrolizumab, cemplimab, nivolumab (flatdose), ipilimumab - nivolumab). Or targeted therapy (dabrafenib-trametinib, encorafenib-binimetinib) - Patients with locally advanced NSCLC stage III or NSCLC stage IV treated with low dose cisplatin and radiation therapy or treated with platinum-doublet chemotherapy with checkpoint inhibition. - Sufficient mastery of the Dutch language - Ambulatory without the use of walking aids - Have an understanding, ability and willingness to fully comply with study procedures and restrictions - > 18 years - Ability to consent
Exclusion criteria
Exclusion criteria: - Known history of heart-rhythm disorder - Incapability of using digital devices - Allergic to surgical steel or elastomer / rubber - Permanent or temporary changes to the skin at locations where the sensors should be worn, (I.e., scar tissue) that might impact sensor performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoints relate to feasibility of study conduct and data collection, as well as to feasibility of a future full-scale study. 1) Recruitment rate: number of included patients relative to the number of invited patients: recruitment rate will be calculated by the percentage of included patients compared to the total number of eligible patients contacted. An overall recruitment rate of 60% at the end of the study will be considered sufficient feasibility. 2) Patient adherence to wear-time Fitbit and Corsano at the designated time periods: Patients will be asked to wear the Corsano and Fitbit 24 hours per day for 12 weeks. Adherence to the designated wear-time will be calculated through the number of hours data gathered compared to the expected amount of data per individual patient in percentages. The average percentage of this parameter provides an overall measure of adherence of the wear-time. We do not set an a-priori feasibility criterion in terms of % adherence, since one of the goals of the preliminary data analysis is to establish how much data is needed to generate potentially useful prediction models. This also applies to endpoints 3 and 4. 3) Technical feasibility of continuous measurements: percentage data loss and gap durations: Data loss may occur due to problems of uploading to the phone or measurement problems. We will compare gathered data in bytes with the expected amount of data corrected for loss data due wear-time and express this number for the individual patient in percentages. Since the amount of acceptable data-loss is dependent, in part, on the possibility to deal with such missing data in the analysis, we do not set an a priori criterion for this outcome. However, extended data loss due to technical malfunction (i.e., Corsano or fitbit not transmitting data for an interval >4 hours, battery failure) should not happen more than once per patient during phase 1. Gap duration will be calculated in time of | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Patient acceptance and experience. After the treatment period, subsequently included participants will be interviewed about their experiences with the use of Corsano and the Fitbit, and about their views about being continuously monitored during treatment. A short, structured interview guide will be prepared. The interview will be audio recorded. Recordings will be transcribed verbatim and qualitative analysis methods (i.e., coding and aggregating) will be applied to analyse the data using appropriate software for qualitative data analysis. Data collection will end once data saturation has been achieved (i.e., when no new viewpoints emerge), while keeping an eye on gender and diagnosis balance. 2) Usability Acceptability/satisfaction. Usability of both devices is assessed by the system usability scale (SUS) which is comprised of 10 statements, rated on a 5-point Likert scale, regarding the usability of an electronic device or platform. Based on previously published studies, a mean SUS score of 68 is chosen as cut point to determine the usability of the system. 3) Treatment-toxicity outcomes: number and grade according to CTCAE of all treatment related toxicity, number and nature of adverse events such as unplanned hospitalisation, unplanned adaptation of treatment plan, visits to the ER, and admission to the ICU, including dates of occurrence. The PRO-CTCAE is a patient reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion tot the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer clinical trials. The questionnaire items evaluate the symptom attributes of frequency, severity, interference, amount and presence/absence. Each symptomatic adverse event is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). Specific items | — |
Countries
Netherlands
Outcome results
None listed