Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Sarcoma, Survivorship, Quality of Life (QOL), Medical Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
Overview
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.
Detailed description
Sarcomas are rare cancers that can arise almost anywhere in the body and account for only about one percent of all cancer diagnoses. Both the disease and its treatments often result in late effects, yet knowledge about these long-term consequences remains limited. 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. Particular focus is placed on subgroups with potential long-term risks, including survivors of bone sarcomas, extremity or trunk sarcomas after multimodal treatment, retroperitoneal sarcomas, gastrointestinal stromal tumors (GIST) with or without long-term TKI therapy, and young adult survivors.
The mixed-methods research design includes a multicenter observational study with a one-time 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.
Recruitment is built on draws on existing network structures, including the PROSa cohort, the National Center for Tumor Diseases (NCT/UCC) Dresden, the SarcBOP registry at the National Center for Tumor Diseases (NCT) Heidelberg, West German Cancer Center Essen (WTZ), University Hospital Mannheim (UMM), the German Sarcoma Foundation, and cooperating sarcoma centers. Medical data are extracted from patient records.
Statistical analyses will include descriptive statistics and regression models to identify impaired quality of life domains and associated factors.
Interventions
- Other No intervention (observational study)
No intervention (observational study)
Primary outcome measures
- Quality of Life (EORTC QLQ-SURV100) [Time frame: single-time point (enrollment)]
- Satisfaction with Medical Care (adapted from EORTC OUT-PATSAT7 & self-developed items) [Time frame: single time point (enrollment)]
- Use of Care Offers (self-developed, adapted from CaSUN) [Time frame: single time point (enrollment)]
- Unmet Needs (self-developed, adapted from CaSUN) [Time frame: single time point (enrollment)]
Secondary outcome measures (10)
- Fatigue (EORTC QLQ-FA12) [Time frame: single-time point (enrollment)]
- Psychological Distress (PHQ-4) [Time frame: single-time point (enrollment)]
- Loneliness (UCLA LS-3) [Time frame: single-time point (enrollment)]
- Physical Complaints (EORTC WISP) [Time frame: single-time point (enrollment)]
- Communication with Healthcare Professionals (adapted from EORTC COMU26 & self-developed items) [Time frame: single-time point (enrollment)]
- Information Sources (self-developed, answer options adapted from CaSUN) [Time frame: single-time point (enrollment)]
- Sociodemographic Items [Time frame: single-time point (enrollment)]
- Socioeconomic Items [Time frame: single-time point (enrollment)]
- Physical Activity (adapted Godin-Shephard Leisure-Time Physical Activity Questionnaire) [Time frame: single-time point (enrollment)]
- Comorbidities [Time frame: single-time point (enrollment)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 5 centers
- Technical University Dresden — Dresden
- University Hospital Essen — Essen
- NCT Heidelberg — Heidelberg
- Sarcoma Center Mannheim — Mannheim
- Deutsche Sarkom-Stiftung — Wölfersheim
Identifiers
NCT: NCT07148193 · SR+BO-EK-452112024 · 70116152