Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Oral Mucositis Malnutrition |
Behavioral: Control Group Behavioral: SCION-HSCT program |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial |
- Health Related Quality of Life (HRQoL) [ Time Frame: day before discharge from hospital ] [ Designated as safety issue: No ]
- Physical Fitness (Step-Test) [ Time Frame: day before discharge from hospital ] [ Designated as safety issue: No ]
- Fatigue (Fatigue Symptom Inventory - D (German)) [ Time Frame: day before discharge from hospital ] [ Designated as safety issue: No ]
- Physical Resources (German Conservation of Resources Evaluation (GCOR)) [ Time Frame: day before discharge from hospital ] [ Designated as safety issue: No ]
- Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0) [ Time Frame: day before discharge from hospital ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 84 |
| Study Start Date: | December 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Care as usual
Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
|
Behavioral: Control Group
Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
|
|
Experimental: 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. |
Behavioral: 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. |
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |
| Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science | |
| Halle/Saale, Sachsen-Anhalt, Germany, 06097 | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Margarete Landenberger, Prof. PhD, Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science |
| ClinicalTrials.gov Identifier: | NCT00804817 History of Changes |
| Other Study ID Numbers: | DKH-Project, DKH Grand Nr. 107498 |
| Study First Received: | December 8, 2008 |
| Last Updated: | August 26, 2010 |
| Health Authority: | Germany: German Institute of Medical Documentation and Information |
Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
|
self management adherence activity enhancement oral mucositis prevention |
and mal nutrition prevention cancer hematopoietic stem cell transplantation (HSCT) loss of activity |
Additional relevant MeSH terms:
|
Stomatitis Malnutrition Mucositis Mouth Diseases Stomatognathic Diseases |
Nutrition Disorders Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013