Clinical trial NCT00804817: Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Official title: Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Malnutrition
Keywords: self management
adherence
activity enhancement
oral mucositis prevention
and mal nutrition prevention
cancer
hematopoietic stem cell transplantation (HSCT)
loss of activity
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2008-12-09
Enrollment: 84
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: day before discharge from hospital
Secondary outcomes:
measure: Physical Fitness (Step-Test)
timeFrame: day before discharge from hospital
measure: Fatigue (Fatigue Symptom Inventory - D (German))
timeFrame: day before discharge from hospital
measure: Physical Resources (German Conservation of Resources Evaluation (GCOR))
timeFrame: day before discharge from hospital
measure: Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)
timeFrame: day before discharge from hospital
Other outcomes:
Locations:
city: Halle/Saale
country: Germany
facility: Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
state: Sachsen-Anhalt
Study officials:
References: