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

NCT00804817 | Completed

• 2 other identifiers: DKH-ProjectDKH Grand Nr. 107498
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life (HRQoL)

  day before discharge from hospital

Secondary Outcomes (4)

• 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

Study Arms (2)

Care as usual

ACTIVE COMPARATOR

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

Behavioral: Control Group

SCION-HSCT program

EXPERIMENTAL

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

Interventions

Control Group BEHAVIORAL

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

Care as usual

SCION-HSCT program BEHAVIORAL

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.

SCION-HSCT program

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to read, write, and understand German

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (1)

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

Halle, Saxony-Anhalt, 06097, Germany

Location

Related Links

• Presentation (12.2007) for work group in psycho oncological cancer care

MeSH Terms

Conditions

Stomatitis; Malnutrition; Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2008-12

Locations

DE (1)