NEMO - an App for Side Effect Management in Oncology

Cancer Patients Clinical Trial

— NEMO  

Official title:

NEMO - an App for Side Effect Management in Oncology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04493450
• Other study ID #: NEMO
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2020
• Source: University of Ulm
• Contact: Thomas Seufferlein, Prof. Dr.
• Phone: +4973150044501
• Email: thomas.seufferlein[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Patients

Intervention

Other:
• Documentation of cancer treatment side effects
Standardized documentation of occurred side effects

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Seufferlein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Patient acceptance of a new medium of communication	Acceptance of documentation of occurring side effects of oncological therapies with new communication media	6 months
Primary	Phase II: Change of occurred adverse events	Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start	6 months
Secondary	Phase II: Doses of chemotherapy	Maintenance of chemotherapy doses through better adverse event management	6 months
Secondary	Phase II: Incidence of adverse events	Incidence of treatment-emergent adverse events as assessed by the CTCAE scale	6 months