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

Phase 3

• Conditions: C00-C97; Malignant neoplasms

• Registration Number: DRKS00027477
• Lead Sponsor: Facharztpraxis Prof. Dr. med Zenner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Study Completion: 2023-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 216

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

-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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer-Related fatigue (Brief Fatigue Inventory):<br>Assessed at T0 (baseline), T1 (4 weeks), T2 (8 weeks), T3 (12 weeks).

Secondary Outcome Measures

Name	Time	Method
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).<br><br>All are assessed at T0 (Baseline), T1 (2 weeks), T2 (6 weeks), T3 (12 weeks).<br><br>The structured interview was developed by Prof. H.P. Zenner (University of Tübingen) and collects objective data.