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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804817
First Posted: December 9, 2008
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Health Related Quality of Life (HRQoL) [ Time Frame: day before discharge from hospital ]

Secondary Outcome Measures:
  • Physical Fitness (Step-Test) [ Time Frame: day before discharge from hospital ]
  • Fatigue (Fatigue Symptom Inventory - D (German)) [ Time Frame: day before discharge from hospital ]
  • Physical Resources (German Conservation of Resources Evaluation (GCOR)) [ Time Frame: day before discharge from hospital ]
  • Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0) [ Time Frame: day before discharge from hospital ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804817


Locations
Germany
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
Halle/Saale, Sachsen-Anhalt, Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Deutsche Krebshilfe e.V., Bonn (Germany)
  More Information

Additional Information:
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
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: August 27, 2010
Last Verified: December 2008

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:
Malnutrition
Mucositis
Stomatitis
Nutrition Disorders
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases


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