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

NCT07148193 | Recruiting DMC

• 2 other identifiers: SR+BO-EK-45211202470116152
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Sarcoma; Neoplasms; Patient-Reported Outcomes; Patient-Reported Experiences; Medical Care; Quality of Life; Unmet Health Needs; Oncology; Psycho-Oncology

Outcome Measures

Primary Outcomes (4)

• Quality of Life (EORTC QLQ-SURV100)

  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.

  single-time point (enrollment)

• Satisfaction with Medical Care (adapted from EORTC OUT-PATSAT7 & self-developed items)

  Satisfaction with medical care and communication will be assessed using three items adapted from the EORTC OUT-PATSAT7 and three self-developed items, all rated on a 1-5 scale. Higher scores indicate greater satisfaction with the medical care received.

  single time point (enrollment)

• Use of Care Offers (self-developed, adapted from CaSUN)

  Service utilization will be assessed with self-developed items based on the Cancer Survivors' Unmet Needs measure (CaSUN). Participants indicate their use of 24 different non-rehabilitation care services and 11 rehabilitation care services. Response options include two types of "No" (offer not available or offer available but not used) and, if "Yes," a rating from 1-3 indicating how helpful the offer was, with higher scores reflecting greater helpfulness.

  single time point (enrollment)

• Unmet Needs (self-developed, adapted from CaSUN)

  Unmet needs will be assessed with self-developed items based on the CaSUN, asking participants about the lack of adequate support or services in 20 areas. Response options include two types of "No" (no need or need has already been met) and, if "Yes," a rating from 1-3 indicating the current intensity of the unmet need, with higher scores reflecting greater unmet need.

  single time point (enrollment)

Secondary Outcomes (10)

• Fatigue (EORTC QLQ-FA12)

  single-time point (enrollment)

• Psychological Distress (PHQ-4)

  single-time point (enrollment)

• Loneliness (UCLA LS-3)

  single-time point (enrollment)

• Physical Complaints (EORTC WISP)

  single-time point (enrollment)

• Communication with Healthcare Professionals (adapted from EORTC COMU26 & self-developed items)

  single-time point (enrollment)

Study Arms (1)

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.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Sarcoma survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Desmoid tumors
• Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Sarcoma Foundation (DSS): collaborator
• German Cancer Research Center: collaborator
• Universitätsmedizin Mannheim: collaborator
• University Hospital, Essen: collaborator
• National Centre for Tumor Diseases Heidelberg: collaborator

Study Sites (5)

Technical University Dresden

Dresden, Saxony, Germany

RECRUITING

University Hospital Essen

Essen, Germany

NOT YET RECRUITING

NCT Heidelberg

Heidelberg, Germany

RECRUITING

Sarcoma Center Mannheim

Mannheim, Germany

RECRUITING

Deutsche Sarkom-Stiftung

Wölfersheim, Germany

RECRUITING

MeSH Terms

Conditions

Sarcoma; Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Martin Eichler, Dr.

  TU Dresden & NCT/ UCC Dresden

  PRINCIPAL INVESTIGATOR

• Karen Steindorf, Prof. Dr.

  DKFZ Heidelberg

  PRINCIPAL INVESTIGATOR

• Richard F. Schlenk, Prof. Dr.

  NCT Heidelberg

  PRINCIPAL INVESTIGATOR

• Jens Jakob, Prof. Dr.

  Sarcoma Center Mannheim

  PRINCIPAL INVESTIGATOR

• Uta Dirksen, Prof. Dr.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

• Markus Wartenberg

  Deutsche Sarkom-Stiftung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Strukelj, M. A.

CONTACT

+493514587056; tanja.strukelj@ukdd.de,

Patricia Blickle, M. Sc.

CONTACT

+49221423506; patricia.blickle@dkfz-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Core Unit Patient-Reported Outcomes at NCT/UCC Dresden

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

DE (5)