Trial document




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  DRKS00012517

Trial Description

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Title

Training in the handling of complementary medicine within the scope of the cancer self-help

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Trial Acronym

[---]*

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URL of the Trial

http://www.kompetenznetz-kokon.de/krebsselbsthilfe

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Brief Summary in Lay Language

The Competence Network Complementary Medicine in Oncology KOKON is a cooperative project sponsored by the German Cancer Aid (second funding phase 2016-2019) investigating the complementary medicine in oncology (CAM) in different subprojects. The overall aim of KOKON is to process science-based knowledge of CAM and to pass on this knowledge to patients, therapists and consultants through appropriate information and education pathways. The present project is a partial project of the competence network and refers to the nationwide implementation and anchoring of a training for cancer self-help groups for dealing with complementary medicine. Therefore group leaders of self-help groups are trained and in a further step conduct the training program thereselves in their self-help groups. The aim by participating in the training is to convey competence to organize science-based information on reliable CAM treatment and applications. The evaluation of the feasibility and sustainability of the training is based on written questionnaires for group leaders and participants (T1 Group leaders and participants directly after the Training, T2 only participants six months later).

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Brief Summary in Scientific Language

The Competence Network Complementary Medicine in Oncology KOKON is a cooperative project sponsored by the German Cancer Aid (second funding phase 2016-2019) investigating the complementary medicine in oncology (CAM) in different subprojects. The overall aim of KOKON is to process science-based knowledge of CAM and to pass on this knowledge to patients, therapists and consultants through appropriate information and education pathways. The present project is a partial project of the competence network and refers to the nationwide implementation of a training for cancer self-help groups for dealing with complementary medicine. The aim by participating in the training is to convey competence to organize evidence-based information on reliable complementary medical therapy offers and to judge them regarding the individual situation. The evaluation of the implementation of the training is based on two measurement-points: instantly at the end of the training and six months later.

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Organizational Data

  •   DRKS00012517
  •   2017/08/23
  •   [---]*
  •   yes
  •   Approved
  •   370/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C61 -  Malignant neoplasm of prostate
  •   C18 -  Malignant neoplasm of colon
  •   C90 -  Multiple myeloma and malignant plasma cell neoplasms
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Interventions/Observational Groups

  •   Implementation, evaluation and catamnestic survey of a training for dealing with complementary medicine in cancer self-help groups
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Effectiveness of the success of the training concept concerning the nationwide implementation in self-help groups in cooperation with three large self-help associations as well as the scientific examination of the sustainability of the medium-term results on attitudes and behavioural changes of group participants in dealing with complementary medicine; target figures are collected through written questionnaires:
(1) evaluation through written survey of the group leaders of self-help groups directly following the train the trainer course (implementation of the course by members of the research group)
(2) time of measurement t1: evaluation of the course directly following the course in the self-help groups (implementation of the course by group leaders without special presentation skills)
a) from the perspective of the group leaders
b) from the perspective of the participants
(3) time of measurement t2: catamnesis after six months: evaluation of the course by written survey of the participants concerning the effects of the course six months ago via postal mail

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Secondary Outcome

Due to the explorative nature of the study there is no explicit primary or secondary outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/10/14
  •   1650
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Participation in a self-help group as well as state after receiving a cancer diagnosis (e.g. lymphoma, leukemia, prostate cancer, breast cancer, gynecological cancer, colon cancer)

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Exclusion Criteria

German language is not understood sufficiently. Patient is assessed as not being able to agree

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Addresses

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    • Universitätsklinikum Freiburg Tumorzentrum / CCC Freiburg Stiftungsprofessur Selbsthilfeforschung
    • Professor Dr.   Joachim  Weis 
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGTumorzentrum / CCC Freiburg Stiftungsprofessur Selbsthilfeforschung
    • Mr.  Professor Dr.  Joachim  Weis 
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Tumorzentrum / CCC Freiburg Stiftungsprofessur Selbsthilfeforschung
    • Ms.  Martina  Jablotschkin 
    • Hugstetter Str. 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.