Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosis of Desmoid tumors
Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
Trial 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
No intervention (observational study)
Other interventionNo intervention (observational study)
Treatment groups
1,600 Participants
are divided into 1 treatment groupGroup A: Sarcoma survivors1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
single-time point (enrollment)2
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.
Time frame
single time point (enrollment)3
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.
Time frame
single time point (enrollment)4
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.
Time frame
single time point (enrollment)Secondary outcomes
1
Fatigue (EORTC QLQ-FA12)
Fatigue will be assessed using the 12-item EORTC QLQ-FA12 scale, which measures physical, emotional, and cognitive aspects of cancer-related fatigue on a 1-4 scale. Higher scores indicate greater fatigue.
Time frame
single-time point (enrollment)2
Psychological Distress (PHQ-4)
Psychological distress will be measured using the four-item PHQ-4, including the diagnostic core criteria for depression (PHQ-2) and generalized anxiety disorder (GAD-2), ranging from 1-4. Higher scores indicate greater psychological distress.
Time frame
single-time point (enrollment)3
Loneliness (UCLA LS-3)
Loneliness will be assessed using the three-item UCLA Loneliness Scale, measuring subjective feelings of loneliness and social isolation, ranging from 1-3. Higher scores indicate greater loneliness.
Time frame
single-time point (enrollment)4
Physical Complaints (EORTC WISP)
Physical complaints will be measured using the EORTC WISP module, allowing participants to report up to three symptoms and rate the degree of burden from 1-4. Higher scores indicate greater impairment due to the respective symptom.
Time frame
single-time point (enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Technische Universität Dresden
Lead sponsor
German Sarcoma Foundation (DSS)
Collaborator
German Cancer Research Center
Collaborator
Universitätsmedizin Mannheim
Collaborator
University Hospital, Essen
Collaborator
National Centre for Tumor Diseases Heidelberg
Collaborator
Source ClinicalTrials.gov