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

Primary Purpose

Oral Mucositis, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Control Group
SCION-HSCT program
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring self management, adherence, activity enhancement, oral mucositis prevention, and mal nutrition prevention, cancer, hematopoietic stem cell transplantation (HSCT), loss of activity

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Care as usual

SCION-HSCT program

Arm Description

Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention

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.

Outcomes

Primary Outcome Measures

Health Related Quality of Life (HRQoL)

Secondary Outcome Measures

Physical Fitness (Step-Test)
Fatigue (Fatigue Symptom Inventory - D (German))
Physical Resources (German Conservation of Resources Evaluation (GCOR))
Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)

Full Information

First Posted
December 8, 2008
Last Updated
August 26, 2010
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT00804817
Brief Title
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

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
Arm Title
SCION-HSCT program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
Intervention Type
Behavioral
Intervention Name(s)
SCION-HSCT program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Related Quality of Life (HRQoL)
Time Frame
day before discharge from hospital
Secondary Outcome Measure Information:
Title
Physical Fitness (Step-Test)
Time Frame
day before discharge from hospital
Title
Fatigue (Fatigue Symptom Inventory - D (German))
Time Frame
day before discharge from hospital
Title
Physical Resources (German Conservation of Resources Evaluation (GCOR))
Time Frame
day before discharge from hospital
Title
Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)
Time Frame
day before discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
City
Halle/Saale
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany

12. IPD Sharing Statement

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

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