Clinical trial · Observational
Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)
Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study PROSa+ aims to assess patient-reported outcomes (PROs), patient-reported experiences (PREs), and the socioeconomic situation of long-term sarcoma survivors (≥ 5 years post-diagnosis, with or without active disease) in Germany. The mixed-methods research design includes a multicenter observational study with a cross-sectional questionnaire survey involving 1,600 participants (paper, online), qualitative interviews with up to 60 participants, and longitudinal analyses combining data from existing sarcoma registries and the previous PROSa study conducted between 2017 and 2020.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medical Care | — | UNRESOLVED | — |
| Quality of Life (QOL) | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sarcoma survivors
- description
- Adults (≥18 years) diagnosed with a sarcoma at least five years prior to study participation, regardless of current disease status, who are treated or receive follow-up care in Germany.
- interventionNames
- Other: No intervention (observational study)
Primary outcomes (4)
- measure
- Quality of Life (EORTC QLQ-SURV100)
- timeFrame
- single-time point (enrollment)
- description
- The EORTC QLQ-SURV100 is a 100-item questionnaire assessing general quality of life among cancer survivors. It includes multiple functional scales covering physical, role, emotional, cognitive, and social functioning, as well as symptom scales (fatigue, pain) and several single-item measures. Most items are rated on a 1-4 scale, while two global items on overall quality of life and general health are rated on a 1-7 scale. Higher scores on the functional and global health status scales indicate better quality of life, whereas higher scores on symptom scales reflect worse quality of life. With the exception of five acute symptoms, the SURV100 includes all items from the EORTC QLQ-C30. To enable comparative analyses, the investigators supplemented the SURV100 with these five missing items: appetite loss, nausea, vomiting, constipation, and diarrhea.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of sarcoma according to the International Classification of Diseases for Oncology (ICD-O) and World Health Organization (WHO) classification, including soft tissue sarcoma, bone sarcoma, and GIST * At least 5 years since initial sarcoma diagnosis * With or without active disease * Age ≥18 years at the time of study participation Exclusion Criteria: * Diagnosis of Desmoid tumors * Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
References
Publications (0)
Data not yet available