NEMO - an App for Side Effect Management in Oncology

Sponsor

Thomas Seufferlein (Other)

Overall Status

Unknown status

CT.gov ID

NCT04493450

Collaborator

(none)

Enrollment

Location

21.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Patients	Other: Documentation of cancer treatment side effects

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

66 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

NEMO - an App for Side Effect Management in Oncology

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Smartphone-users Cancer patients who use smartphones	Other: Documentation of cancer treatment side effects Standardized documentation of occurred side effects

Arm

Intervention/Treatment

Smartphone-users

Cancer patients who use smartphones

Other: Documentation of cancer treatment side effects

Standardized documentation of occurred side effects

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Ulm	Ulm		Germany

Sponsors and Collaborators

Thomas Seufferlein

Investigators

Principal Investigator: Seufferlein, University Hospital Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Seufferlein, Professor, Head of Department, University of Ulm

ClinicalTrials.gov Identifier:

NCT04493450

Other Study ID Numbers:

NEMO

First Posted:

Jul 30, 2020

Last Update Posted:

Aug 3, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2020