NEMO - an App for Side Effect Management in Oncology
NEMO
1 other identifier
observational
66
1 country
1
Brief Summary
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 3, 2020
July 1, 2020
1.3 years
July 23, 2020
July 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Phase II: Doses of chemotherapy
6 months
Phase II: Incidence of adverse events
6 months
Study Arms (1)
Smartphone-users
Cancer patients who use smartphones
Interventions
Standardized documentation of occurred side effects
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- Participants who meet any of the following criteria will be excluded:
- severe neurological disorders
- severe psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Ulm
Ulm, Germany
Related Publications (1)
Kestler AMR, Kuhlwein SD, Kraus JM, Schwab JD, Szekely R, Thiam P, Huhne R, Jahn N, Furstberger A, Ikonomi N, Balig J, Schuler R, Kuhn P, Steger F, Seufferlein T, Kestler HA. Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. PLoS One. 2021 Jun 4;16(6):e0252493. doi: 10.1371/journal.pone.0252493. eCollection 2021.
PMID: 34086740DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Seufferlein
University Hospital Ulm
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Head of Department
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 30, 2020
Study Start
September 1, 2020
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
August 3, 2020
Record last verified: 2020-07