Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Malnutrition Clinical Trial

Official title:

Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804817
• Other study ID #: DKH-Project
• Secondary ID: DKH Grand Nr. 10
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: August 26, 2010
• Start date: December 2007
• Est. completion date: August 2010

Study information

• Verified date: December 2008
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science	Halle/Saale	Sachsen-Anhalt

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life (HRQoL)		day before discharge from hospital	No
Secondary	Physical Fitness (Step-Test)		day before discharge from hospital	No
Secondary	Fatigue (Fatigue Symptom Inventory - D (German))		day before discharge from hospital	No
Secondary	Physical Resources (German Conservation of Resources Evaluation (GCOR))		day before discharge from hospital	No
Secondary	Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)		day before discharge from hospital	Yes

External Links

•   Presentation (12.2007) for work group in psycho oncological cancer care
•   Trial abstract at the home page at the Department for Health and Nursing Science, Halle/Saale, Germany