NEMO - an App for Side Effect Management in Oncology

• Conditions: Cancer Patients
• Interventions: Other: Documentation of cancer treatment side effects

• Registration Number: NCT04493450
• Lead Sponsor: Thomas Seufferlein

Brief Summary

This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.

Detailed Description

This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03
• Study Start: 2020-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies
• combination of at least two immune-checkpoint inhibitors
• able to read and understand German

Exclusion Criteria

Participants who meet any of the following criteria will be excluded:

• severe neurological disorders
• severe psychiatric disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smartphone-users	Documentation of cancer treatment side effects	Cancer patients who use smartphones

Primary Outcome Measures

Name	Time	Method
Phase I: Patient acceptance of a new medium of communication	6 months	Acceptance of documentation of occurring side effects of oncological therapies with new communication media
Phase II: Change of occurred adverse events	6 months	Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start

Secondary Outcome Measures

Name	Time	Method
Phase II: Doses of chemotherapy	6 months	Maintenance of chemotherapy doses through better adverse event management
Phase II: Incidence of adverse events	6 months	Incidence of treatment-emergent adverse events as assessed by the CTCAE scale

Trial Locations

Locations (1)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany