Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010128

Trial Description

start of 1:1-Block title

Title

Evaluation of a Best-Practice Model for Multiprofessional Medication Management in Cancer Patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MuMM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Due to its complexity, anti-cancer treatment is associated with a high risk of adverse drug events. In this study feasibility and acceptance of a newly developed best-practice model for multiprofessional medication management (MuMM) was evaluated and its potential to attenuate therapy-associated toxicity was analyzed. The best-practice model combines interventions at the level of clinical staff members, anti-cancer therapy, and the patient. These are implemented in the form of a medication management, an individually optimized supportive care, and patient counselling interviews regarding adverse drug events of chemotherapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Due to its complexity, anti-cancer treatment is associated with a high risk of adverse drug events. In this prospective, single center, two-arm randomized study feasibility and acceptance of a newly developed best-practice model for multiprofessional medication management (MuMM) was evaluated and its potential to attenuate therapy-associated toxicity was analyzed. The best-practice model combines interventions at the level of clinical staff members, anti-cancer therapy, and the patient. These are implemented in the form of a medication management, an individually optimised supportive care, and patient counselling interviews regarding adverse drug events of chemotherapy. During six cycles of chemotherapy, patients in the control arm received standard care whereas participants randomized to the intervention arm received MuMM. Among others, patient-reported symptom load (PRO-CTCAE), quality of life (EORTC QLQ-C30 and EQ-5D-3L), and patient satisfaction with the information on cancer treatment (PS-CaTE) are defined as study endpoints.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010128
  •   2016/03/07
  •   [---]*
  •   yes
  •   Approved
  •   250/12, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patient care based on the developed multiprofessional medication managenemt provided by physician, pharmacist and nurse for a maximum of six treatment cycles
  •   Standard patient care provided by physician and nurse for a maximum of six treatment cycles
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Percentage of patients with at least one toxicity score 3-4 according to PRO-CTCAE referring to the symptoms nausea and vomiting, mucositis, fatigue, pain, diarrhea, constipation, dry mouth, dysphagia, loss of appetite, sleep disorders (at the beginning of every treatment cycle retrospectively assessed over the past seven days for a maximum of six treatment cycles)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Percentage of patients with toxicity, i.e. with score >0 according to PRO-CTCAE (at the beginning of every treatment cycle); quality of life for the patients using EORTC QLQ-C30 questionnaire and EQ-5D-3L questionnaire (at the beginning of every treatment cycle); patient satisfaction with the information on cancer treatment according to PS-CaTE (at the beginning of the first and last treatment cycle); frequency of occurrence of malnutrition (SGA category C) (at the beginning of every treatment cycle); percentage of patients with current, written medication plan (at the beginning of every treatment cycle)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/11/16
  •   74
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Diagnosis of a solid tumor; outpatient tumor treatment in the Oncological Outpatient Department of Internal Oncology of the Johanniter Hospital in Bonn; written consent of the patient; ability to speak and understand German

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Diseases where the patient is unable to understand the type and content of the study and it can be excluded that the patient correctly understands the questionnaire or is able to fill it out on his own (e.g. Alzheimer's disease); intention to change the location of treatment in the near future

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinische Pharmazie
    • Mr.  Prof. Dr.  Ulrich  Jaehde 
    • An der Immenburg 4
    • 53121  Bonn
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinische Pharmazie
    • Mr.  Prof. Dr.  Ulrich  Jaehde 
    • An der Immenburg 4
    • 53121  Bonn
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinische Pharmazie
    • Mr.  Prof. Dr.  Ulrich  Jaehde 
    • An der Immenburg 4
    • 53121  Bonn
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinische Pharmazie
    • Mr.  Prof. Dr.  Ulrich  Jaehde 
    • An der Immenburg 4
    • 53121  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/05/06
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.