Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Mucositis
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Health Related Quality of Life (HRQoL)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This study will test the SCION (Self care improvement through oncology nursing)-HSCT program a multi-modular, somatic-psycho-social care intervention to improve self management in oncologic patients undergoing HSCT. The study will determine if the self management skills of the patients to enhance:
- physical activity,
- prevention of oral mucositis and
- mal nutrition during the period of hospitalization.
It is hypothesized that patients who receive the multi-modular somatic-psycho-social care intervention will have better health related quality of life (HRQoL).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hematologic Patients (\> 14 years of age)
- •Hematological stem cell transplantation (HSCT) allogenic or autologous
- •Informed consent
Exclusion Criteria
- •Unable to read, write, and understand German
Outcomes
Primary Outcomes
Health Related Quality of Life (HRQoL)
Time Frame: day before discharge from hospital
Secondary Outcomes
- Physical Fitness (Step-Test)(day before discharge from hospital)
- Fatigue (Fatigue Symptom Inventory - D (German))(day before discharge from hospital)
- Physical Resources (German Conservation of Resources Evaluation (GCOR))(day before discharge from hospital)
- Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)(day before discharge from hospital)