Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 5
- 主要终点
- Quality of Life (EORTC QLQ-SURV100)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of Desmoid tumors
- •Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
结局指标
主要结局
Quality of Life (EORTC QLQ-SURV100)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
- Information Sources (self-developed, answer options adapted from CaSUN)(single-time point (enrollment))
- Sociodemographic Items(single-time point (enrollment))
- Socioeconomic Items(single-time point (enrollment))
- Physical Activity (adapted Godin-Shephard Leisure-Time Physical Activity Questionnaire)(single-time point (enrollment))
- Comorbidities(single-time point (enrollment))
研究者
Martin Eichler
Head of the Core Unit Patient-Reported Outcomes at NCT/UCC Dresden
Technische Universität Dresden