Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Joachim Weis
Medical University Centre Freiburg
Freiburg, Germany
Study coordinator(s)
Andrea Kiemen
Medical University Centre Freiburg
Freiburg, Germany

Project summary

Fertility preservation (FP) has become an important quality of life issue to the growing population of cancer survivors treated during their fertile years. Most of the patients with malignant cancer in the reproductive age and their relatives or partners desire to receive information related to fertility protection and FP. Lack of information can negatively influence decision‐making and increase decisional conflict, which can be associated with emotional distress and future decisions’ regret. Women and men report a need for information on FP strategies and decision support while reviewing their options during the brief, stressful window of time before initiating cancer treatment.

The primary objective of this cooperative project of the ESGO (European Society for Gynaecological Cancer) and the EORTC-QoL Group is the development of a validated questionnaire instrument that covers all fertility issues related to quality of life including the individual patients’ need for information and counselling, coping strategies, and costs of individual FP strategies. The questionnaire is designed for measuring these issues in all treatment phases and in all relevant diagnoses.

Achievements

Since start of the project in Aug-15, 2018 (timeline 0-6months):

  • Update of literature search
  • Finalization of the study protocol, the patient information leaflet, and Informed Consent Form for submission to the EC
  • Finalization of the list of issues designed for patients and partners, and health care professionals
  • Collaborators contract forms

Phase I; Submission of ethic approval application to the leading EC

Future plans

Start of health care professional (HCP) interviews in March, 2019

Timeline 6-12 months:

Obtaining ethical approval, translation of the issue list into language of the collaborators respectively, patients’ and partners’ interviews.

Timeline 12-18 months:

Analysis of data, preparing phase 1-2 report to PMDC.

Timeline 18-21 months:

Construction of provisional module, preparing translations and study forms for phase 3.

Timeline 21-30 months:

Phase 3 data collection (patients’ interviews), data entry and analysis.

Timeline 30-36 months:

Data analysis, preparation of phase 3 report/paper.

For patients

Cancer itself or anti-cancer treatments may affect fertility (the ability to conceive a baby) temporarily or permanently. Many women and men who have been diagnosed with cancer think preserving their fertility is important and want information about their options. However, patients may be focused on their cancer diagnosis and unable to think about fertility or the possibility of having a future family. Providing information and support to at-risk patients in a timely manner can improve patients’ emotional outlook and future quality of life. This project develops a patients’ questionnaire that covers all fertility related quality of life issues for use in daily oncology practice.