C51 C52 C53 C54
Conditions
Interventions
Group 1: Arm 1 includes all patients receiving radiotherapy as part of routine clinical care.
After providing written informed consent, patients participate in the study without any influence on thei
Sponsors
Uniklinikum Düsseldorf
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histologically confirmed vulvar, vaginal, cervical, or endometrial cancer Planned radiotherapy (primary, adjuvant, or palliative) Ability to provide informed consent and written informed consent Sufficient German language skills to independently complete the questionnaires
Exclusion criteria
Exclusion criteria: Age under 18 years Pregnancy Inability to provide informed consent (e.g. due to severe psychiatric illness or cognitive impairment) Insufficient German language skills Participation in a concurrent interventional study with potential influence on quality of life or study endpoints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in global health status (EORTC QLQ-C30 GHS score) from baseline before the start of radiotherapy (T0) to 12 months after completion of radiotherapy (T3), assessed using the validated EORTC QLQ-C30 questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in additional functional and symptom scales of quality of life (EORTC QLQ-C30 and tumor-specific modules CX24, EN24, VU34) over time (T0–T3) Changes in cancer-related fatigue (EORTC QLQ-FA12) over time Changes in sleep quality (Insomnia Severity Index) over time Occurrence and severity of treatment-related symptoms Comparison of quality of life between different tumor entities Analysis of short- and long-term treatment-related burden | — |
Countries
Germany
Contacts
Public ContactLivia schmidt
Universitätsklinikum Düsseldorf
Outcome results
None listed