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

Not Applicable

Completed

• Conditions: Oral Mucositis; Malnutrition
• Interventions: Behavioral: Control Group; Behavioral: SCION-HSCT program

• Registration Number: NCT00804817
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Study Timeline

• Study Start: 2007-12
• Status Verified: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Hematologic Patients (> 14 years of age)
• Hematological stem cell transplantation (HSCT) allogenic or autologous
• Informed consent

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Exclusion Criteria

• Unable to read, write, and understand German

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care as usual	Control Group	Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
SCION-HSCT program	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.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life (HRQoL)	day before discharge from hospital

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science; 🇩🇪 Halle/Saale, Sachsen-Anhalt, Germany