Cancer PatientsNEMONCT04493450
NEMO - an App for Side Effect Management in Oncology
An observational study of Cancer Patients, run by Thomas Seufferlein at 1 site in Germany.
Trial summary
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients
- What is being tested?
- Documentation of cancer treatment side effects
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 30 Jun 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Participants who meet any of the following criteria will be excluded:
- severe neurological disorders
- severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.
Read the 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.
- Conditions
- Cancer Patients
- Being tested
- Documentation of cancer treatment side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Documentation of cancer treatment side effectsOther
Standardized documentation of occurred side effects
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-users | Cancer patients who use smartphones Receives: Other: Documentation of cancer treatment side effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Patient acceptance of a new medium of communication
Acceptance of documentation of occurring side effects of oncological therapies with new communication media
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Phase II: Doses of chemotherapy
Maintenance of chemotherapy doses through better adverse event management
Measured: 6 months
Phase II: Incidence of adverse events
Incidence of treatment-emergent adverse events as assessed by the CTCAE scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Thomas Seufferlein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Seufferlein, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493450
- Sponsor's protocol ID
- NEMO
- Acronym
- NEMO
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34086740
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEMO - an App for Side Effect Management in Oncology
- ClinicalTrials.gov ID
- NCT04493450
- Acronym / sponsor ID
- NEMO / NEMO
- Conditions
- Cancer Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Thomas SeufferleinUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone-users | – | Other: Documentation of cancer treatment side effectsCancer patients who use smartphones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- severe neurological disorders
- severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Documentation of cancer treatment side effectsStandardized documentation of occurred side effects | Other | Smartphone-users |
Primary outcome
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
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
2 secondary outcomes
Phase II: Doses of chemotherapy
Time frame: 6 months
Phase II: Incidence of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 34086740Kestler 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seufferlein principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients, run by Thomas Seufferlein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Seufferlein, Prof. Dr. (+4973150044501, thomas.seufferlein@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Patient acceptance of a new medium of communication (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.