NEMO - an App for Side Effect Management in Oncology (NEMO)

July 30, 2020 updated by: Thomas Seufferlein
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany
        • Universitätsklinikum Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Phase I:

- 30 participants in total non-randomly divided into three age groups (< 55 years, 55-75 years, > 75 years) of 10 people each.

Phase II:

- 36 participants randomly assigned a group of 18 persons (smartphone users, non-smartphone users)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Seufferlein

Investigators

  • Principal Investigator: Seufferlein, University Hospital Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NEMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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