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Prospective Randomized Group Controlled Study of Clinical Efficacy and Safety of the CE-marked Untire App

Prospective Randomized Group Controlled Study of Clinical Efficacy and Safety of the CE-marked Untire App - Untire II

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027477
Enrollment
214
Registered
2022-05-02
Start date
2022-04-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-C97

Interventions

Group 1: Intervention group: At the beginning of the study, the intervention group will receive access to the psycho-oncological Untire app and a face-to-face introduction in the study center. Over th

Sponsors

Facharztpraxis Prof. Dr. med Zenner
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age 18 years or older - Formally diagnosed with a malignancy - 90 days after therapy start or later - Experiences fatigue at the moderate or severe level: an average composite score (items 1-9) of =4 on the Brief Fatigue Inventory (BFI) - German fluency and literacy - Access to smartphone and internet

Exclusion criteria

Exclusion criteria: -Inability to provide an informed consent -Average composite score (items 1-9) of 3 or less on the Brief Fatigue Inventory (BFI) -No ability to use a smart phone or a tablet -Not German speaking -Use of Untire in the control group -Patients receiving end of life care -Fatigue is caused by demonstrable medical factors such as dehydration, anemia and kidney malfunction. -Patients with other fatigue syndromes than CRF, such as fibromyalgia and chronic fatigue syndrome (CFS) -Receiving treatment for a psychiatric disorder ***Absolute contraindications -acute illnesses -acute relapses or decompensation in chronic diseases -fever > 38 degrees -severe pain -inadequately adjusted blood pressure in hypertension ***Relative contraindications -anemia < 8 g/dL -Thrombocytopenia and coagulation disorders -bone metastases -Comorbidities such as CHD, pAVK, arterial hypertension, diabetes mellitus, osteoarthritis -administration of cytostatic drugs on the day of sport -mediastinal/cardiac irradiation -flu-like symptoms during immunotherapies -epilepsy

Design outcomes

Primary

MeasureTime frame
Cancer-Related fatigue (Brief Fatigue Inventory): Assessed at T0 (baseline), T1 (4 weeks), T2 (8 weeks), T3 (12 weeks).

Secondary

MeasureTime frame
Quality of life (EORTC QLQ-C30), psychological distress (distress thermometer (DT)), depression (HADSD), anxiety (HADSD), adherence and compliance (structured interview), patient sovereignty (structured interview), costs (structured interview). All are assessed at T0 (Baseline), T1 (2 weeks), T2 (6 weeks), T3 (12 weeks). The structured interview was developed by Prof. H.P. Zenner (University of Tübingen) and collects objective data.

Countries

Germany

Contacts

Public ContactHans-Peter Zenner

Facharztpraxis Prof. Dr. med Zenner

office@hpzenner.de07071-49645

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026