Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial
According to Precede Model of health behavior from Green - modified by our research group -
patients self management skills are affected by the patients' knowledge, activities and
attitude to self management.
Therefore, we propose a prospective non-randomized clinical trial that will test the
effectiveness of SCION-HSCT program against care as usual on perceived HRQoL of the patient
and the adherence to care program.
Oncology patients with HSCT will be recruited by the nurses of the participating wards under
the guidance of a research nurse. They will be included in the trial if they will meet the
inclusion criteria and signed informed consent (the full inclusion criteria see below).
Groups will be treated consecutively. The first group will receive care as usual (Control).
After finishing the control period, i.e. after 42 Patients will have completed the trial.
The the newly assigned patients will be treated according to SCION-HSCT program a
multi-modular somatic-psycho-social care intervention (Intervention).
The intervention will be conducted by specially trained ward nurses in cooperation with the
research nurse. It includes components of knowledge, skills training, and coaching to
improve patients adherence to self management strategies for physical activity, prevention
of oral mucositis and mal nutrition prevention. The HRQoL, adherence and symptom level of
the patients will be observed up to 100 days post HSCT. Both quantitative and qualitative
analyses will be conducted to evaluate patient outcomes.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Health Related Quality of Life (HRQoL)
day before discharge from hospital
Germany: German Institute of Medical Documentation and Information