ung Artificial Intelligence-enabled Digital Solution Pilot Study

• Conditions: C34; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00025509
• Lead Sponsor: MSD SHARP & DOHME GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Kaiku® Health Patient Access<br>o 1+ successful log-in attempt during the study period<br>- LungAid-ePRO Module Patient Access<br>o 1+ questionnaire successfully submitted after baseline. <br>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<br>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:<br>