C50
Conditions
Interventions
Group 1: Intervention group:
Participants use the Untire app in addition to standard treatment for 12 weeks, with access to the app provided for 18 months. After the primary endpoint is reached at thr
Sponsors
Tired of Cancer B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Informed consent signed • Formally diagnosed with breast cancer stages I-III (diagnosis confirmed by the investigator) • Completed primary oncological treatment (i.e., curative surgery and/or curative radiotherapy and/or curative chemotherapy and/or curative immunotherapy) at least three weeks prior to the study except for hormonal/antihormonal or neoadjuvant/adjuvant/targeted therapy treatment (requirement of completed wound healing). • 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: • Breast cancer: UICC IV (all T, all N, M1), • 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 • usage of the Untire app before the study for both groups and Untire app use for the control group during the study • Patients receiving palliative (including end of life care) • In-faust prognosis • Fatigue is caused by demonstrable non-oncological factors such as dehydration, anemia and kidney malfunction • Patients with other fatigue syndromes then CRF, such as fibromyalgia and chronic fatigue syndrome (CFS). This is checked by the case history (using a checklist that patients were asked by the study doctor, patients were asked to bring the hospital/doctor report which is checked by the study doctor, further, lab test reports were checked by the study doctor) • Relevant severe psychiatric differential diagnosis and severe comorbidities, checked by study doctor based on the hospital and or doctors’ report/doctors case report, are excluded (e.g., severe depression). • Severe sleep-wake disorders (i.e., severe hypersomnia) • Receiving treatment (i.e., medication) for a severe psychiatric disorder at inclusion • Acute illnesses and/or acute relapses or decompensation in chronic diseases that prevents patients from participation in the study in the opinion of the study physician • Fever > 38 degrees • Severe pain (usually indicates analgesics drug use) • Inadequately adjusted blood pressure in hypertension Relative contraindications: • anemia < 8 g/dL • Thrombocytopenia and coagulation disorders • Comorbidities such as CHD, pAVK, arterial hypertension, diabetes mellitus, osteoarthritis • mediastinal/cardiac irradiation • epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer-Related Fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue scale) - Baseline (at the time of recruitment) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cancer-Related Fatigue (Brief Fatigue Inventory) - Baseline (at the time of recruitment) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) Functional Assessment of Cancer Therapy - General (FACT-G Total Score) - Baseline (at the time of recruitment) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) | — |
Countries
Germany
Contacts
Public ContactHans-Peter Zenner
Facharztpraxis
Outcome results
None listed