Quality of Life and Medical Care of Long-term Sarcoma Survivors in Germany (PROSa+)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention (observational study).
- Кому может быть актуально
- Состояния в реестре: Sarcoma, Survivorship, Quality of Life (QOL), Medical Care. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Understanding Long-Term Sarcoma Survivorship: Risk Profiles, Outcomes and Unmet Needs - A Joint Project of Research, Sarcoma Centres and Patient Experts (PROSa+)
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое No intervention (observational study)
No intervention (observational study)
Первичные конечные точки
- Quality of Life (EORTC QLQ-SURV100) [Срок оценки: single-time point (enrollment)]
- Satisfaction with Medical Care (adapted from EORTC OUT-PATSAT7 & self-developed items) [Срок оценки: single time point (enrollment)]
- Use of Care Offers (self-developed, adapted from CaSUN) [Срок оценки: single time point (enrollment)]
- Unmet Needs (self-developed, adapted from CaSUN) [Срок оценки: single time point (enrollment)]
Вторичные конечные точки (10)
- Fatigue (EORTC QLQ-FA12) [Срок оценки: single-time point (enrollment)]
- Psychological Distress (PHQ-4) [Срок оценки: single-time point (enrollment)]
- Loneliness (UCLA LS-3) [Срок оценки: single-time point (enrollment)]
- Physical Complaints (EORTC WISP) [Срок оценки: single-time point (enrollment)]
- Communication with Healthcare Professionals (adapted from EORTC COMU26 & self-developed items) [Срок оценки: single-time point (enrollment)]
- Information Sources (self-developed, answer options adapted from CaSUN) [Срок оценки: single-time point (enrollment)]
- Sociodemographic Items [Срок оценки: single-time point (enrollment)]
- Socioeconomic Items [Срок оценки: single-time point (enrollment)]
- Physical Activity (adapted Godin-Shephard Leisure-Time Physical Activity Questionnaire) [Срок оценки: single-time point (enrollment)]
- Comorbidities [Срок оценки: single-time point (enrollment)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Diagnosis of Desmoid tumors
- Inability to complete a structured questionnaire (e.g., due to insufficient German language skills, cognitive impairment, dementia)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Германия · 5 центров
- Technical University Dresden — Dresden
- University Hospital Essen — Essen
- NCT Heidelberg — Heidelberg
- Sarcoma Center Mannheim — Mannheim
- Deutsche Sarkom-Stiftung — Wölfersheim
Идентификаторы
NCT: NCT07148193 · SR+BO-EK-452112024 · 70116152