Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)

NCT ID: NCT07148193

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-28
• Study Completion Date: 2027-09-30

Brief Summary

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.

Conditions

Sarcoma; Survivorship; Quality of Life (QOL); Medical Care

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sarcoma survivors

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.

No intervention (observational study)

Intervention Type: OTHER

No intervention (observational study)

Interventions

No intervention (observational study)

No intervention (observational study)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

German Sarcoma Foundation (DSS)

UNKNOWN

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Universitätsmedizin Mannheim

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: collaborator

National Centre for Tumor Diseases Heidelberg

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Martin Eichler

Head of the Core Unit Patient-Reported Outcomes at NCT/UCC Dresden

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Eichler, Dr.

Role: PRINCIPAL_INVESTIGATOR

TU Dresden & NCT/ UCC Dresden

Karen Steindorf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

DKFZ Heidelberg

Richard F. Schlenk, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

NCT Heidelberg

Jens Jakob, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Sarcoma Center Mannheim

Uta Dirksen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Markus Wartenberg

Role: PRINCIPAL_INVESTIGATOR

Deutsche Sarkom-Stiftung

Locations

Technical University Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

University Hospital Essen

Essen, , Germany

Site Status: NOT_YET_RECRUITING

NCT Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Sarcoma Center Mannheim

Mannheim, , Germany

Site Status: RECRUITING

Deutsche Sarkom-Stiftung

Wölfersheim, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tanja Strukelj, M. A.

Role: CONTACT

tanja.strukelj@ukdd.de,

+493514587056

Patricia Blickle, M. Sc.

Role: CONTACT

patricia.blickle@dkfz-heidelberg.de

+49221423506

Facility Contacts

Tanja Strukelj, M.A.

Role: primary

tanja.strukelj@ukdd.de

+493514587056

Uta Dirksen, Prof. Dr.

Role: primary

Richard F. Schlenk, Prof. Dr.

Role: primary

Jens Jakob, Prof. Dr.

Role: primary

Markus Wartenberg

Role: primary

Other Identifiers

70116152

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SR+BO-EK-452112024

Identifier Type: -

Identifier Source: org_study_id