Trial document





This trial has been registered retrospectively.
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  DRKS00016024

Trial Description

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Title

Phase 1-3 development of an EORTC module assessing fertility issues and patient care needs

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Trial Acronym

EORTC - Fertility

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URL of the Trial

https://qol.eortc.org/questionnaire/fertility/

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Brief Summary in Lay Language

To develop a valid questionnaire (phase 1-3) instrument that covers all fertility related quality of life issues including the individual oncology patients' need for information and counselling in men and women in the reproductive age, respectively.

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Brief Summary in Scientific Language

EORTC QoL module fertility for measuring outcome of information and treatment of fertility preservation counselling.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016024
  •   2020/02/04
  •   [---]*
  •   yes
  •   Approved
  •   77/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1225-0019 
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Objective: The questionnaire module will be developed as an independent questionnaire according to the EORTC QLQ guideline in a multi-center study. The questionnaire will be used in clinical studies to evaluate consultations on fertility maintenance measures and the measures taken to protect fertility, as well as to assess the information and consultation needs of patients in oncological practice.

    Duration of study: 36 months

    Multicentric: 8 countries (Germany, Austria, Belgium, England, Netherlands, Poland, Serbia, Spain)

    Methodology
    Phase 1/2: 7 patients/country + 3 partners/country (total 80 participants)
    5 health care professionals (HCPs)/country (total 40 HCPs)

    Phase 3: 8 patients per treatment option (surgery, systemic therapy, radiotherapy, combined treatment), diagnosed with one of the diagnoses below in at least 8 countries (8x4x8 = total 256)

    Newly diagnosed female premenopausal patients younger than 42 years and male patients without age limit, each with a cancerous disease affecting their fertility (gynaecological tumors, tumors of the bladder, intestine, testicles, prostate, breast, as well as sarcomas and lymphomas), who are under acute treatment or in the post-treatment phase and are in various medical treatment situations, each with curative intention (surgery, systemic therapy, radiotherapy, combined treatment).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Development of a stand-alone questionnaire in accordance with the EORTC QLG guideline.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Serbia
  •   Netherlands
  •   Poland
  •   Portugal
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • other 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/04
  •   256
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients are eligible if they have / are
• signed the written informed consent to participate in the study
• a primary diagnosis of
o gynaecological cancer
o bladder cancer
o colorectal cancer
o testicular cancer
o prostate cancer
o breast cancer
o sarcoma and
o lymphoma
• Female patients > 18 years to 42 years
• Female patients in pre-menopause
• Male patients > 18 years
• Patients in any treatment with curative intention affecting fertility, focusing on
o Surgery
o Systemic therapy
o Radiotherapy
o Combined therapy (radiation, surgery, systemic treatment)

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Exclusion Criteria

Patients with other than the above mentioned diagnoses and treatments, that are contradictionnairy to the inclusion criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Interdisziplinäres Tumorzentrum - CCCF - Stiftungsprofessur Selbsthilfeforschung
    • Mr.  Prof.  Joachim   Weis 
    • Hugstetterstr. 49
    • 79106  Freiburg
    • Germany
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    • European Organisation of Research and Treatement (EORTC) Quality of Life Group
    • Avenue E. Mounier 83/11
    • 1200  Brussels
    • Belgium
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    • Interdisziplinäres Tumorzentrum - CCCF - Stiftungsprofessur Selbsthilfeforschung
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Hugstetterstr. 49
    • 79106  Freiburg
    • Germany
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    • Interdisziplinäres Tumorzentrum - CCCF - Stiftungsprofessur Selbsthilfeforschung
    • Ms.  Dr.  Andrea  Kiemen 
    • Hugstetterstr. 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • European Organisation of Research and Treatement (EORTC) Quality of Life Group
    • Avenue E. Mounier 83/11
    • 1200  Brussels
    • Belgium
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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