SarcomaPROSa+NCT07148193
Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)
An observational study of Sarcoma and Survivorship, run by Technische Universität Dresden at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Survivorship, Quality of Life (QOL)
- How many people
- 1,600 participants
- Where
- 5 sitesGermany
- Study dates
- 28 Nov 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Diagnosis of Desmoid tumors
- Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Technical University Dresden
Dresden, Saxony
Tanja Strukelj, M.A., +493514587056, tanja.strukelj@ukdd.de
- Not yet recruiting
University Hospital Essen
Essen
Uta Dirksen, Prof. Dr.
- Recruiting
NCT Heidelberg
Heidelberg
Richard F. Schlenk, Prof. Dr.
- Recruiting
Sarcoma Center Mannheim
Mannheim
Jens Jakob, Prof. Dr.
- Recruiting
Deutsche Sarkom-Stiftung
Wölfersheim
Markus Wartenberg
About this study
Official title: Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
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.
Read the 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
- Being tested
- No intervention (observational study)
- Keywords
- Sarcoma, Neoplasms, Patient-Reported Outcomes, Patient-Reported Experiences, Medical Care, Quality of Life, Unmet Health Needs, Oncology, Psycho-Oncology
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: single time point (enrollment)
Secondary outcomes (10)
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.
Measured: single-time point (enrollment)
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.
Measured: single-time point (enrollment)
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.
Measured: single-time point (enrollment)
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.
Measured: single-time point (enrollment)
Communication with Healthcare Professionals (adapted from EORTC COMU26 & self-developed items)
Communication experiences will be assessed using nine items adapted from the EORTC COMU26 and nine self-developed items, focusing on perceived quality and clarity of communication with healthcare providers. Rated on a 1-4 scale, higher scores indicate greater satisfaction with communication.
Measured: single-time point (enrollment)
Information Sources (self-developed, answer options adapted from CaSUN)
Information sources will be assessed using nine self-developed items, asking participants where they obtain cancer-related information. Response options include two types of "No" (not known or known but not used) and, if "Yes," a rating from 1-3 indicating how helpful the source was, with higher scores reflecting greater helpfulness.
Measured: single-time point (enrollment)
Sociodemographic Items
Sociodemographic characteristics, including age, sex, and migration background will be collected.
Measured: single-time point (enrollment)
Socioeconomic Items
Socioeconomic status will be assessed through items measuring i.a. education, employment status, and income.
Measured: single-time point (enrollment)
Physical Activity (adapted Godin-Shephard Leisure-Time Physical Activity Questionnaire)
Physical activity will be measured using an adapted version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire. This 4-item questionnaire evaluates the frequency and duration of mild, moderate and vigorous aerobic activities, as well as moderate-to-vigorous strength training, performed during the week. Scores reflect whether participants meet exercise guidelines:
- Aerobic guidelines: ≥75 min of vigorous or ≥150 min moderate activity (meeting guidelines) vs. 0-149 minutes of moderatre and vigorous activity per week (not meeting guidelines)
- Resistance guidelines: ≥2 resistance sessions/week (meeting guidelines) vs. <2 sessions (not meeting guidelines) Higher scores indicate better adherence to physical activity recommendations.
Measured: single-time point (enrollment)
Comorbidities
Information on comorbid conditions (e.g., cardiovascular disease, diabetes, depression) will be collected, capturing co-existing health conditions. The total number of comorbidities will be summed and used as a control variable in the analyses.
Measured: single-time point (enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start28 Nov 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Sarcoma Foundation (DSS), German Cancer Research Center, Universitätsmedizin Mannheim, University Hospital, Essen, National Centre for Tumor Diseases Heidelberg
- Responsible party
- Principal investigator, Martin Eichler, Technische Universität Dresden
- Investigators
- Martin Eichler, Dr., Principal investigator, TU Dresden & NCT/ UCC DresdenKaren Steindorf, Prof. Dr., Principal investigator, DKFZ HeidelbergRichard F. Schlenk, Prof. Dr., Principal investigator, University Hospital HeidelbergJens Jakob, Prof. Dr., Principal investigator, Sarcoma Center MannheimUta Dirksen, Prof. Dr., Principal investigator, University Hospital, EssenMarkus Wartenberg, Principal investigator, Deutsche Sarkom-Stiftung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148193
- Sponsor's protocol ID
- SR+BO-EK-452112024
- Other IDs
- 70116152
- Acronym
- PROSa+
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
- ClinicalTrials.gov ID
- NCT07148193
- Acronym / sponsor ID
- PROSa+ / SR+BO-EK-452112024
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Sarcoma Foundation (DSS), German Cancer Research Center, Universitätsmedizin Mannheim, University Hospital, Essen, National Centre for Tumor Diseases Heidelberg
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoma survivors | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of Desmoid tumors
- Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Sarcoma survivors |
Primary outcome
Quality of Life (EORTC QLQ-SURV100)
Time frame: single-time point (enrollment)
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.
Satisfaction with Medical Care (adapted from EORTC OUT-PATSAT7 & self-developed items)
Time frame: single time point (enrollment)
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.
Use of Care Offers (self-developed, adapted from CaSUN)
Time frame: single time point (enrollment)
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.
Unmet Needs (self-developed, adapted from CaSUN)
Time frame: single time point (enrollment)
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.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Eichler, Dr. principal investigator
TU Dresden & NCT/ UCC Dresden
Karen Steindorf, Prof. Dr. principal investigator
DKFZ Heidelberg
Richard F. Schlenk, Prof. Dr. principal investigator
University Hospital Heidelberg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Survivorship, run by Technische Universität Dresden at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanja Strukelj, M. A. (+493514587056, tanja.strukelj@ukdd.de,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EORTC QLQ-SURV100) (time frame: single-time point (enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.