Erfassung von Vitaldaten mittels Smartwatches bei Patienten mit Kopf-Hals-Tumoren – eine Machbarkeitsstudie

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Mit dem Ziel zukünftig mehr Patientinnen mit Kopf-Hals-Tumoren zu regelmäßiger körperlicher Aktivität zu motivieren, soll im Rahmen dieser Studie der Einsatz von Wearables in Form von Smartwatches getestet werden. Diese bieten im Vergleich zu Aktimetern mehrere Vorteile. Sie machen u. a. den tatsächliche Bewegungsumfang für den Nutzer direkt sichtbar und können zudem weitere Parameter objektiv erfassen. Diese Parameter können, speziell bei Patientinnen mit schlechter körperlicher Fitness, zusätzliche Informationen zur tatsächlichen Belastungsintensität liefern. Dies wiederum kann potentiell genutzt werden, um ein gezieltes Training zu planen bzw. zu steuern, um adäquate Trainingsreize setzen zu können, ohne die Patientinnen zu überfordern.

Programme: Universitätsmedizin Rostock (UMR)

SEEK ID: https://ldh.mediz-rostock.imise.uni-leipzig.de/projects/17

Public web page: Not specified

Organisms: No Organisms specified

NFDI4Health PIs: No PIs for this Project

Project created: 20th Jan 2026

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : Erfassung von Vitaldaten mittels Smartwatches bei Patienten mit Kopf-Hals-Tumoren – eine Machbarkeitsstudie
Language of the title/name(*) : German

Title/name(*) : Monitoring vital data by smartwatches in patients with head and neck cancer – a feasibility study (MOVE-1)
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : MOVE-1
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : Mit dem Ziel zukünftig mehr Patient*innen mit Kopf-Hals-Tumoren zu regelmäßiger körperlicher Aktivität zu motivieren, soll im Rahmen dieser Studie der Einsatz von Wearables in Form von Smartwatches getestet werden. Diese bieten im Vergleich zu Aktimetern mehrere Vorteile. Sie machen u. a. den tatsächliche Bewegungsumfang für den Nutzer direkt sichtbar und können zudem weitere Parameter objektiv erfassen. Diese Parameter können, speziell bei Patient*innen mit schlechter körperlicher Fitness, zusätzliche Informationen zur tatsächlichen Belastungsintensität liefern. Dies wiederum kann potentiell genutzt werden, um ein gezieltes Training zu planen bzw. zu steuern, um adäquate Trainingsreize setzen zu können, ohne die Patient*innen zu überfordern.
Language of the description(*) : German

Description(*) : With the aim of motivating more patients with head and neck cancers to engage in regular physical activity in the future, this study will test the use of wearables in the form of smartwatches. These offer several advantages over actimeters. Among other things, they make the actual amount of activity directly visible to the user and can also objectively record other parameters. These parameters can provide additional information on the actual intensity of exercise, especially in patients with poor physical fitness. This, in turn, can potentially be used to plan or control targeted training in order to set adequate training stimuli without overtaxing the patients.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : head and neck cancer

Keyword(*) : supportive care

Keyword(*) : smartwatch

Keyword(*) : physical exercise

Keyword(*) : quality of life (QoL)

Language(s) of the project : German

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Sabine
Family name(s)(*) : Felser
Digital identifier(s)
Identifier(*) : 0000-0002-4882-0468
Scheme(*) : ORCID
Email address : sabine.felser@med.uni-rostock.de
Phone number : +49 (0)381 494 7395
Organisation(s) associated with the contributor
Name(*) : Universitätsmedizin Rostock
Address : Schillingallee 35, 18057 Rostock
Web page : https://www.med.uni-rostock.de/
Digital identifier(s)
Identifier(*) : 0000 0000 9737 0454
Scheme(*) : ISNI
Identifier(*) : 04dm1cm79
Scheme(*) : ROR
Name(*) : Klinik und Poliklinik für Hämatologie, Hämostaseologie, Onkologie, Stammzelltherapie und Palliativmedizin
Address : Ernst-Heydemann-Straße 6, 18057, Rostock, Deutschland
Web page : https://onkologie.med.uni-rostock.de/
Digital identifier(s)
Identifier(*) : 04dm1cm79
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00032658

Includes chronic diseases? : true

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : Cross-sectional
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : head and neck cancer
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C76.0
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Yes
Start date : 16 May 2024
End date : 30 November 2024
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : Male, Female, Diverse
Inclusion criteria : written and spoken command of the German language; patients with tumors in the oral, maxillofacial, and head and neck region undergoing antineoplastic or palliative therapy (radiotherapy, surgery, chemotherapy, or immunotherapy), or in follow-up care; the patient must be able to perform the tasks required in the study
Exclusion criteria : patients who are not capable of giving informed consent; not all inclusion criteria met
Population of the Project(*)
Coverage : Regional
Country(ies) : Germany
Region(s) and/or city(ies) : Mecklenburg-Vorpommern
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Other
Additional information about the intervention : Patients with head and neck tumors wear a smartwatch for 7 days (24 hours a day) and complete questionnaires before and after
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Wearing a smartwatch for 7 days (24 hours a day)
Type of the exposure : Other
Additional information about the exposure : Patients with HNC wear a smartwatch for 7 days (24 hours a day) and complete questionnaires before and after
Name(s) of the group(s) associated with the given exposure : patients with head and neck cancer
Outcome measures in the Project
Name of the outcome measure(*) : Adherence to wearing a smartwatch for one week (24/7) and the extent of recording target parameters
Description of the outcome measure : Analysis of the data on the smartphone
Type of the outcome measure : Primary
Time point(s) of assessment : After completion of the predefined wearing period
Name of the outcome measure(*) : Frequency of use of the smartwatch display function to check physical activity (e.g., step count)
Description of the outcome measure : via log
Type of the outcome measure : Secondary
Time point(s) of assessment : recorded daily during the week of wear
Name of the outcome measure(*) : Amount and intensity of physical activity and time spent inactive
Description of the outcome measure : Analysis of the data on the smartphone
Type of the outcome measure : Secondary
Time point(s) of assessment : After completion of the predefined wearing period
Name of the outcome measure(*) : Subjective physical activity
Description of the outcome measure : Saltin–Grimby Physical Activity Level Scale
Type of the outcome measure : Secondary
Time point(s) of assessment : assessed once before the start of the wearing period
Name of the outcome measure(*) : Quality of life
Description of the outcome measure : EORTC QLQ-C30 and Modul QLQ-H&N43
Type of the outcome measure : Secondary
Time point(s) of assessment : assessed once after completion of the wearing period
Name of the outcome measure(*) : Recruitment rate
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Yes, there is a plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : 10 years
Criteria for data access : reasoned request
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : No
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Cross-sectional, Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

Erfassung von Vitaldaten mittels Smartwatches bei Patienten mit Kopf-Hals-Tumoren – eine Machbarkeitsstudie

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