Trial document




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  DRKS00004309

Trial Description

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Title

Study to pilot-test an oral care self-management support protocol (OrCaSS) regarding feasability and effectiveness in patients with acute myeloid leukemia prior to allogeneic stem cell transplantation to prevent chemotherapy-related oral mucositis: a randomized, controlled pilot study

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Trial Acronym

OrCaSS

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URL of the Trial

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Brief Summary in Lay Language

Oral mucositis (mouth sores) can occur as an unwanted side effect after high-dose Chemoherapie prior to allogeneic stem cell transplantation. Of patients point of view, oral mucositis is one of the most unpleasant side effects due to pain by swallowing and may cause limitations in quality of life. From previous studies we know that an oral care protocol can help to alleviate oral mucositis, reduce or even prevent it completely. The aim of this pilot study is to check the feasibility of an oral care protocol and its effectiveness to reduce oral mucositis.
An evidence-based oral care protocol was developed and will be tested in comparison to the existing oral care standard. Patients diagnosed with acute myeloid leukemia that are scheduled for an allogeneic stem cell transplantation will be included. During a routine appointment 1 week before hospitalization, patients will be ask to participate and then randomly assigned to either intervention or control group. Patients in the intervention group, learn how to use the self-assessment instrument and how they should base their oral care on it. Further they learn an appropriate brushing technique and the use of mouth rinses. A refresher of the training takes place on day of admission to the transplant unit. Criteria which will be evaluated are occurrence, severity and duration of oral mucositis. Further protocol adherence, quality of life and how symptoms are experienced.
The aims of this pilot study are threefold:
1.To develop a structured nurse-led intervention to support oral care self-management for preventing OM in patients with AML undergoing allogeneic HSCT (OrCaSS).
2.To pilot test OrCaSS:
a.in view of its feasibility
b.and estimate effect sizes regarding incidence, severity and duration of OM.
3.To investigate the impact of OrCaSS on secondary outcomes (i.e., patients’ adherence to OrCaSS, Quality of Life (QoL) and symptom experience).

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Brief Summary in Scientific Language

Background: About 1000 patients diagnosed with Acute Myeloid Leukemia (AML) undergo their first or follow up allogeneic hematopoietic stem cell transplantation (HSCT) every year in Germany. While substantial improvements in supportive care have reduced the severity of many chemotherapy related side effects, oral mucositis (OM) is one of the most debilitating side effects and affects up to 99% of these patients. OM can result in systemic infections, with prolonged hospital stays and additional costs. Due to pain OM impacts patients’ ability to eat drink or swallow.
Little is known about prevention strategies according to oral care protocols. However, data indicate that a systematically applied and evidence based oral care protocol might influence the incidence, severity and duration of OM.
Objective: To assess the effectiveness of a newly developed oral care self-management support (OrCaSS) protocol in view of feasibility and to estimate effect sizes regarding incidence, severity and duration of OM. Secondly to investigate the impact of OrCaSS on patients’ adherence, quality of life and symptom experience.
Design, Setting, Sample: Randomized controlled pilot study in 20 patients diagnose with AML undergoing allogeneic HSCT conducted at the medical center Freiburg between August 2012 and April 2013.
Methods: First we developed OrCaSS, an evidence based oral care self-management support protocol based on effective interventions found in the literature and on existing guidelines. The control group will receive usual care the intervention group will receive OrCaSS which includes two educational sessions and includes structured and tailored components.
Study procedures: All interventions will be provided by the Study Director (SD, first author) and the Principle Investigator (PI, second author). Both will be trained by a dentist and hygienist how to teach patients doing their oral care. OM will be assessed daily from day of admission till day 20 after allogeneic HSCT by three independent trained Bachelor prepared nurses. Adherence, symptom experience and quality of life will be measured at three times.
Data Analysis: Data files will be built and analyzed using SPSS 19.0. Descriptive statistics will be applied as appropriate for all variables. Baseline characteristics, incidence, severity and duration of OM between the intervention and the control group will be compared by using t-or Wilcoxon Rank-sum-tests as appropriate. Differences between groups regarding onset and ending of OM will be compared by applying Cox proportional hazard model. A level of p<0.05 is considered to be statistically significant.
Keywords: oral mocositis, oral care protocol, allogeneic hematopoietic stem cell transplantation

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Organizational Data

  •   DRKS00004309
  •   2012/08/16
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  •   yes
  •   Approved
  •   257/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   K12.3 -  [generalization K12: Stomatitis and related lesions]
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Interventions/Observational Groups

  •   Patients in the control group will receive usual care which is based on a standard operating procedure (SOP) and includes oral cryotherapy for patients who receive Melphalane ≥ 140mg/m2 and starts at the first day of hospital admission. Furthermore, the SOP includes information for nurses to assess the oral status, inform all patients receiving chemotherapy about the risk of developing OM and that they should perform regular oral rinses. It further includes a written information sheet for patients and a list of several care products (e.g. sage and other herbal tea, chlorhexidine and/or alcohol containing rinses) from which each nurse can choose a product to offer the patient. This may lead to different recommendations, depending on the preferences’ of each nurse. The SOP does not include any further self-management support, as instructions about the correct tooth brushing technique, a self-assessment tool or other techniques for improving patients’ adherence. From a previous practice development project at the Department of Hemato-Oncology, it is known, that the SOP is applied inconsistently and unsystematically during routine practice. The basic oral assessment and the daily follow up as well as information about OM, may mostly rely on individual motivation, time and work load of the staff nurses. Patients receive if any, only one educational session and evaluation is mostly not guaranteed. This may lead to insufficient adherence to oral care during inpatient time.
  •   Patients in the intervention group will receive OrCaSS which includes two educational sessions, which will be described in more detail in the following paragraphs. All interventions will be performed by the SD who is a specialized hemato-oncology nurse and will be trained by a dentist how to perform oral examinations and how to teach patients performing oral care. The first session will be given one week before admission to the transplant unit the second session will be held one or two days after admission for HSCT.
    The first session will include structured components which every patient receives in the same way and tailored components which are individually adapted. It is based on categories that are derived from Michie et al.. The categories used for this intervention include two structured and five tailored categories: “providing information on consequences of behavior in general”, “prompt self-monitoring of behavioral outcome” (structured components); “providing information on where and when to perform the behavior”, “providing instructions on how to perform the behavior”, “demonstrating the behavior” , “teaching to use cues” and “goal setting” (tailored components).
    Providing information on consequences of behavior in general: Patients receive oral information about the pathogenesis, impact and complications of OM. They learn about prevention strategies for OM. An oral examination will be done with the patient to demonstrate how to do the oral examination. A professional tooth cleaning by a dentist and dental hygienist will be recommended prior to allogeneic HSCT.
    Prompt self-monitoring of behavioral outcome: All patients assigned to the OrCaSS intervention will be trained to monitor their oral status daily by using the German pediatric version of the Oral Mucositis Daily Questionnaire (OMDQ) as self-assessment tool. Furthermore all patients get a laminated measure sheet and are instructed on how to base the choice and frequency of mouth rinses on their self-assessment.
    Providing information on where and when to perform the behavior: Patients will be encouraged to start with basic oral rinses and tooth brushing two times a day at home. Patients learn about the oral rinses and when and how to escalate according to the oral care protocol which they are supposed to apply during the inpatient time.
    Providing instructions on how to perform the behavior; demonstrating the behavior, teaching to use cues: To instruct patients on the proper tooth brushing technique, they will be asked to brush their teeth as usual. Afterwards plaque will be measured with a plaque disclosing tablet and the plaque index and patients receive training how to use the modified Bass tooth brushing technique for at least 90 seconds to remove the dyeing. Furthermore, patients will be encouraged to air-dry the tooth brush afterwards. If patients indicate that they expect having problems, they learn how to use reminders.
    Goal setting: Goals will be set together with the patients according to their self-assessed ability to implement the recommended strategies into daily life (e.g., following the oral care protocol at least six days a week). Materials given to patients. Patients receive an oral care package including: laminated self-assessment scale and a hardcopy of the oral care protocol, one bottle sparkling mineral water as basic oral mouthwash, one chlorhexidine free antiseptic mouthwash (Octenidol®), 5 extra soft tooth brushes, 20 foam swabs, tooth paste (Sensodyne®), lip- and nose salve, sugar free chewing gums, 3 mouth mirrors and an hourglass for timing tooth brushing and rinsing.
    The second session will also be based on the components above mentioned, but tailored to the patients’ individual needs. They will receive a refresher of the training and have the possibility of asking further questions. If patients report problems, to follow the oral care protocol, measures to increase adherence will be discussed (e.g., patients will be taught to use reminders such as mobile phone alerts). All educational sessions will last 20-25 minutes each and will be adapted individually according to the patient’s learning abilities in terms of duration and content. Learning progress and the reaching of the set goals will be assessed by using a short questionnaire with general questions regarding OM (e.g. prevention strategies, asking for goal achievement; see appendix 5). Behavioral change will be assessed via interview by using the BAASIS and discussed with the patients in order to enhance adherence with the recommended strategies.
    The SD will follow a detailed intervention protocol and document each session (Appendix 13). For quality assurance the principle investigator (PI; AK, second author) will check protocols and discuss deviances with the SD until an 80% protocol adherence is achieved. In addition, AK will be trained to substitute the PI during her absence. All patients will receive i.v. morphine if they develop a need for analgesics due to OM depending pain.

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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   caregiver, assessor
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Duration, severity and incidence of OM

OM is measured daily with the WHO toxicity scale from the day of admission until day 20 after transplantation

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Secondary Outcome

Adherence: is measured with the BAASIS and the plaque index on day of admission and at day 8,9 or 10 after transplantation

Quality of life: is measured using the EORTC QLQ C30 1 week before transplantation, at the day of admission and at day 8,9 or 10 after transplantation

Symptom Experience: is measured using PROVIVO at day 8,9 or 10 after transplantation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/20
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Read and speak German, have no oral mucositis at the time of recruitment, are to perform oral care independently in the situation

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Exclusion Criteria

diagnosed psychiatric disorderor any other disabilities which prevents an adequate communication

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Addresses

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    • Universitätsklinikum Freiburg Abteilung Hämatologie/Onkologie
    • Ms.  PhD  Antje  Koller 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Lynn  Leppla 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Abteilung Hämatologie/Onkologie
    • Ms.  Lynn  Leppla 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Ms.  Lynn  Leppla 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Hämatologie/Onkologie Pflege
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/01
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Trial Publications, Results and other Documents

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