Oral MucositisNCT00804817
Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
A study testing SCION-HSCT program in people with Oral Mucositis and Malnutrition, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Oral Mucositis, Malnutrition
- What is being tested?
- SCION-HSCT program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hematologic Patients (> 14 years of age)
- Hematological stem cell transplantation (HSCT) allogenic or autologous
- Informed consent
Who cannot join
- Unable to read, write, and understand German
Trial locations and contacts
1 site in 1 country.
Germany1 site
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Department for Health and Nursing Science
Halle, Saxony-Anhalt, 06097
About this study
Official title: Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial
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).
Read the 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.
- Conditions
- Oral Mucositis, Malnutrition
- Being tested
- Control Group, SCION-HSCT program
- Keywords
- self management, adherence, activity enhancement, oral mucositis prevention, and mal nutrition prevention, cancer, hematopoietic stem cell transplantation (HSCT), loss of activity
- Medical subject headings
- Stomatitis, Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
Control: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention
SCION-HSCT programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | Active comparator | Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention Receives: 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. Receives: Behavioral: SCION-HSCT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQoL)
Measured: day before discharge from hospital
Secondary outcomes (4)
Physical Fitness (Step-Test)
Measured: day before discharge from hospital
Fatigue (Fatigue Symptom Inventory - D (German))
Measured: day before discharge from hospital
Physical Resources (German Conservation of Resources Evaluation (GCOR))
Measured: day before discharge from hospital
Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)
Measured: day before discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804817
- Sponsor's protocol ID
- DKH-Project
- Other IDs
- DKH Grand Nr. 107498
- Status last verified
- Dec 2008
- First submitted
- 8 Dec 2008
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00804817
- Acronym / sponsor ID
- DKH-Project
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | Active comparator | Behavioral: Control GroupCare as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention |
| SCION-HSCT program | Experimental | Behavioral: SCION-HSCT programPatients 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hematologic Patients (> 14 years of age)
- Hematological stem cell transplantation (HSCT) allogenic or autologous
- Informed consent
Key exclusion criteria (1 listed)
- Unable to read, write, and understand German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupControl: Care as usual, i.e. standard physical activity enhancement, oral mucositis prevention and treatment and mal nutrition prevention | Behavioural | Care as usual |
| SCION-HSCT programIntervention: 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. | Behavioural | SCION-HSCT program |
Primary outcome
Health Related Quality of Life (HRQoL)
Time frame: day before discharge from hospital
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
- Presentation (12.2007) for work group in psycho oncological cancer careLink provided by the sponsor.
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCION-HSCT program in people with Oral Mucositis and Malnutrition, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQoL) (time frame: day before discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.