C34
Conditions
Interventions
Group 1: The patient will document symptoms and HRQoL data via the Kaiku® Health application. To determine the experience of the patients with this software, a study specific electronic patient report
Sponsors
MSD SHARP & DOHME GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. =18 years old at study inclusion 2. Confirmed metastatic NSCLC as determined by the treating physician 3. Previously untreated for metastatic disease with treatment decision already made by treating physician on first line therapy with pembrolizumab based regimen for metastatic disease as defined by European market authorization 4. ECOG performance Status 0-2 5. Owner of a web-connected, frequently used, electronic device (smartphone, tablet, computer) and an email address, 6. Internet access available at home 7. Fluent in written and spoken German 8. Provided written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. Patients previously documented within this study 2. Has received systemic therapy for the treatment of their stage IV NSCLC at the time of enrollment 3. Unable to participate in an initial training or to regularly use the Kaiku® Health AI-enabled remote symptom monitoring solution or the ePRO module as assessed by the treating physician during informed consent process
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Kaiku® Health Patient Access o 1+ successful log-in attempt during the study period - LungAid-ePRO Module Patient Access o 1+ questionnaire successfully submitted after baseline. The requirement is met if at least one of the three HRQoL questionnaires (EQ-5D, EORTC-QLQ-C30, SF-36) was successfully submitted at least once after the baseline visit If 50% of consenting patients meet the criteria for both Kaiku® Health Patient Access and LungAid-ePRO Module Patient Access, then the following secondary outcomes of interest will be considered for analysis: | — |
Secondary
| Measure | Time frame |
|---|---|
| - Kaiku® Health completion/compliance proportion (to be calculated for the following timepoints: at anytime during follow-up, biweekly, and monthly) o Number with successful module submissions in numerator, number of all patients having signed the written informed consent in the denominator - Lung-Aid-ePRO completion/compliance proportion (to be calculated for each instrument (EQ-5D-5L, EORTC-QLQ-C30, SF-36) at each scheduled timepoint*) o Number with successful questionnaire submission in numerator, number of having signed the written informed consent in the denominator - LungAid-ePRO Patient Burden o Distribution of scores for each item on the ePRO Burden Questionnaire every six weeks* during follow-up - Kaiku® Health Patient Perception (assessed via the LungAid EDC system) o Distribution of scores for each item on the Kaiku® Health user satisfaction questionnaire at week 6* o Distribution of scores for each item on the Usefulness of Kaiku® Health questionnaire at week 12* o Distribution of scores for each item on the System Usability Scale questionnaire at week 12* - Kaiku® Health Provider Perception (assessed via the LungAid EDC system) o Distribution of scores for each item on the Kaiku® Health user satisfaction questionnaire at the earliest pembrolizumab 1L start date for enrolled patients at the respective site + 6 weeks* o Distribution of scores for each item on the Usefulness of Kaiku® Health questionnaire at the earliest pembrolizumab 1L start date for enrolled patients at the respective site + 12 weeks* o Distribution of scores for each item on the System Usability Scale questionnaire at 6 weeks before the end of study* - Reimbursement coding o Charged reimbursement categories as documented by the HCPs | — |
Countries
Germany
Contacts
Public ContactNina Gruber
MSD Sharp & Dohme GmbH
Outcome results
None listed