Skip to main content
Clinical Trials/NCT06623786
NCT06623786
Not Yet Recruiting
N/A

Cancer Patient Remote Monitoring for Timely Communication Study

Asklepios proresearch0 sites100 target enrollmentOctober 2024
ConditionsNSCLC Stage IV

Overview

Phase
N/A
Intervention
Not specified
Conditions
NSCLC Stage IV
Sponsor
Asklepios proresearch
Enrollment
100
Primary Endpoint
adherence to use the remote monitoring app
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1/L1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard/physician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
April 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Asklepios proresearch
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed Informed Consent Form
  • Age \> 18 years at the time of study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy \> 6 months
  • Patient is able and willing to use smart phone and a wearable device/technology/sensor

Exclusion Criteria

  • Previous systemic treatment for metastatic or locally advanced disease

Outcomes

Primary Outcomes

adherence to use the remote monitoring app

Time Frame: 6 months

To measure the adherence to use the remote monitoring app, assessed as percentage of answered questions related to the total number of questions sent to the patients via Q1.6 app

Similar Trials