Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
NCT ID: NCT00804817
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2007-12-31
2010-08-31
Brief Summary
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* 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).
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Care as usual
Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
Control Group
Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
SCION-HSCT program
Patients receive SCION-HSCT program a multi-modular somatic-psycho-social care intervention. consisting of 3 modules: Activity Enhancement, Oral Mucositis Prevention and Mal-Nutrition Avoidance.
The intervention will be conducted by specially trained oncology nurses and will include components of knowledge, skills training, and coaching to improve self management. The intervention starts at admission followed by booster sessions during the period of hospitalization. Patients will be scheduled to an individualized physical activity program incl. endurance training on light level 60-80% of max heart rate. Additionally the patient will be counselled to follow a mouth care protocol based on self assessment of the mouth to prevent oral mucositis. Both interventions are accompanied by a systematic screening of the nutritional situation. All three interventions are aimed to improve patients' adherence to self management strategies of side effects.
SCION-HSCT program
Intervention: Patients receive SCION-HSCT program a multi-modular somatic-psycho-social care intervention. consisting of 3 modules: Activity Enhancement, Oral Mucositis Prevention and Mal-Nutrition Avoidance.
The intervention will be conducted by specially trained oncology nurses and will include components of knowledge, skills training, and coaching to improve self management. The intervention starts at admission followed by booster sessions during the period of hospitalization. Patients will be scheduled to an individualized physical activity program incl. endurance training on light level 60-80% of max heart rate. Additionally the patient will be counselled to follow a mouth care protocol based on self assessment of the mouth to prevent oral mucositis. Both interventions are accompanied by a systematic screening of the nutritional situation. All three interventions are aimed to improve patients' adherence to self management strategies of side effects.
Interventions
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Control Group
Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
SCION-HSCT program
Intervention: Patients receive SCION-HSCT program a multi-modular somatic-psycho-social care intervention. consisting of 3 modules: Activity Enhancement, Oral Mucositis Prevention and Mal-Nutrition Avoidance.
The intervention will be conducted by specially trained oncology nurses and will include components of knowledge, skills training, and coaching to improve self management. The intervention starts at admission followed by booster sessions during the period of hospitalization. Patients will be scheduled to an individualized physical activity program incl. endurance training on light level 60-80% of max heart rate. Additionally the patient will be counselled to follow a mouth care protocol based on self assessment of the mouth to prevent oral mucositis. Both interventions are accompanied by a systematic screening of the nutritional situation. All three interventions are aimed to improve patients' adherence to self management strategies of side effects.
Eligibility Criteria
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Inclusion Criteria
* Hematological stem cell transplantation (HSCT) allogenic or autologous
* Informed consent
Exclusion Criteria
14 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
Locations
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Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
Halle, Saxony-Anhalt, Germany
Countries
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Related Links
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Presentation (12.2007) for work group in psycho oncological cancer care
Other Identifiers
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DKH Grand Nr. 107498
Identifier Type: -
Identifier Source: secondary_id
DKH-Project
Identifier Type: -
Identifier Source: org_study_id
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