ABCSG 22R-QoL Details

A questionnaire investigating long-term quality of life (QoL) outcome including sexual health and fertility concerns based survey among breast cancer patients registered in ABCSG 22R.

Start: 07/2019
Coordinating Investigator: Bjelic-Radisic, Vesna; Wuppertal/Herdecke
Sample size: 600 (national)

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Survey design:

ABCSG 22R Quality of Life is designed as a multicenter cross-sectional survey and is conducted in eleven Austrian ABCSG sites which cooperated in the ABCSG 22R registry and expressed their will for further participation. The survey which started in July 2019 with a total duration of estimated 36 months, aims to receive a total of 600 completed paper based questionnaires.

Aim and research question:

This survey aims at investigating long-term quality of life (QoL) outcome including sexual health and fertility concerns in breast cancer survivors (stage of after-care) who have been pooled in the ABCSG 22R registry.

In detail, the study addresses the following research questions:

  • Evaluation of QoL outcome including sexual health and fertility concerns in breast cancer survivors registered in ABCSG 22R who previously received endocrine therapy with tamoxifen (Novaldex®) ± goserelin (Zoladex®) or tamoxifen (Novaldex®) ± Anastrozole (Arimidex®) ± chemotherapy ± zoledronic acid (Zometa®)
  • Evaluation of the impact of different treatment modalities (endocrine therapy alone vs. endocrine therapy + chemotherapy ) on QoL outcome, sexual health and fertility
  • Comparison of QoL outcome in metastatic breast cancer patients vs. non-metastatic patients registered in ABCSG 22R
  • Comparison of QoL outcome in breast cancer patients vs. women from the general population (reference data)
  • Validation of the SABIS (sexual adjustment and body image scale) and fertility-related questionnaire according to a study of Thewes et al. 2005 in the German speaking breast cancer population
  • Evaluation of compliance

Inclusion criteria:

  • Females registered in ABCSG 22R. Premenopausal women with proven, hormone-sensitive breast cancer and already started treatment with Nolvadex® and Zoladex® were included in the 22R Registry.
  • Signed written informed consent
  • Age >18 years
  • Sufficient knowledge of German
  • No cognitive impairments

Exclusion criteria:

  • Secondary carcinoma in the medical history
  • Non fulfilment of the inclusion criteria