Trial document





This trial has been registered retrospectively.
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  DRKS00017766

Trial Description

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Title

Perception of side effects of oncological systemic therapy in patients with breast and gynecological cancers

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Trial Acronym

KEM-GO-1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Systemic oncologic therapy plays a significant role in the treatment of gynecological malignancies including breast cancer. Both the composition of the cytostatic therapy regimen and the planned duration of therapy have undergone great change in recent years / decades. Targeted therapy with with eg trastuzumab, bevacizumab leads to a prolongation of the therapy duration which usually goes beyond the time of classical chemotherapy. Side effects / symptoms of systemic therapies are assessed differently by patients at different levels. Thanks to supportive care therapies, some dose-limiting side effects can be avoided thus keeping therapy tolerable. The subjective perception and its importance of side effects of systemic therapy are subject to a verifiable change over the past 30 years. The purpose of this study is to update and re-evaluate patient information on the perception of side effects / symptoms of systemic therapy in gynecologic oncology, with a particular focus on comparison with studies conducted and published in this form since 1983

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Brief Summary in Scientific Language

Evaluation of patients perception of side effects of systemic oncologic therapy. Comparison with previously published analyses based on same interview. In addition the long term effects on patients perception of side effects of maintenance therapy (for example trastuzumab or bevacizumab) will be evaluated.

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Organizational Data

  •   DRKS00017766
  •   2019/08/05
  •   [---]*
  •   yes
  •   Approved
  •   2015147, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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

  •   C56 -  Malignant neoplasm of ovary
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Patients with breast or ovarian cancer who are indicated for chemotherapy due to their tumor biology will be offered to participate in the study. After approval, the interview takes place. Here, the study participants are presented with laminated index cards, which contain written terms that represent possible symptoms / side effects of systemic therapy. The symptoms are divided into two different categories:

    Group A) List of physical symptoms - 45 cards
    Group B) List of Non-Physical Symptoms- 27 Cards

    The patients are asked to take the important cards from both groups. In a next step they are mixed and finally the patient is asked to take the five most important cards from this new set of cards and to list them in a ranking.
    Overall, the patient is asked to complete the interview at five different times (before, during, at the end, 6 and 12 months after chemotherapy).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

This prospective study aims to investigate how side effects of systemic therapy of patients with gynecologic malignancies are perceived and assessed / categorized in their significance.

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Secondary Outcome

Evaluation of perception of side effects and their importance in patients undergoing maintenance therapy
• Evaluation of perception of side effects at different times of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/11/27
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Age >18 years
Initial chemotherapy treatment at the Department of Gynecology & Gynecologic Oncology of the Essen-Mitte Hospital for senological or gynecological tumors
Willingness to participate in the study + signed consent form

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Exclusion Criteria

Lack of German understanding
Reading difficulties / illiteracy
expected life duration of therapy <3 months

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Addresses

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    • Kliniken Essen Mitte
    • Ms.  PD  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45316  Essen
    • Germany
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    • Kliniken Essen Mitte
    • Ms.  PD  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45316  Essen
    • Germany
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    • Kliniken Essen Mitte
    • Ms.  PD  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45316  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken Essen Mitte
    • Ms.  PD  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45316  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/23
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   KEM-GO-1Protokoll
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* This entry means the parameter is not applicable or has not been set.