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

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention (observational study): No intervention (observational study)

Study 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.

Eligibility

Primary outcome measure(s)

• Quality of Life (EORTC QLQ-SURV100) — 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) — 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) — 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) — 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.

Trial sites (5)

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