C56 C57 C48 C55 C53 C57.8 C54
Conditions
Interventions
Group 1: Intervention Group:
Consultation for long-term survivors with gynecologic tumor disease (baseline, follow-up after 6 months, final visit after 12 months) with the following intervention optio
Sponsors
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie; Charité – Universitätsmedizin Berlin; Campus Virchow-Klinikum
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Initial diagnosis of a gynecologic tumor disease (ovarian, endometrial, or cervical cancer) at least five years ago.
Exclusion criteria
Exclusion criteria: - Insufficient written and spoken German language skills - Individuals who are not capable of giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in health-related quality of life after 12 months compared to baseline. A clinically relevant improvement is defined as an increase in quality of life by at least 6 points in at least one of the two summated scores of the SF-36 (physical or psychological summated score). | — |
Secondary
| Measure | Time frame |
|---|---|
| Main clinical secondary endpoints: Cancer-specific quality of life (QLQ-C30), tumor entity-specific quality of life (ovary-28, cervix-24, endometrium-24), health-related quality of life (physical and mental sum score of the SF-36), frequency and severity of long-term side effects (including fatigue, sleep disturbances, depression, polyneuropathy, chemobrain), physical activity, bone density and cardiotoxicity, hand strength, nutritional status and antioxidant status, mortality. All secondary endpoints are assessed at 12 months and in some cases additionally at 3, 6, and 9 months. Main health economic secondary endpoints (secondary data): health care resource utilization before and during intervention (e.g., outpatient physician contacts, inpatient treatments), direct health care costs, indirect costs due to sick days, type and frequency of physician-coded long-term adverse events. | — |
Countries
Germany
Contacts
Public ContactHannah Woopen
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie; Charité – Universitätsmedizin Berlin; Campus Virchow-Klinikum
Outcome results
None listed