Status:
COMPLETED
Self-efficacy Coaching for Women With Breast Cancer
Lead Sponsor:
Stiftung Patientenkompetenz
Collaborating Sponsors:
iOMEDICO AG
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is an open, prospective, multi-center, interventional study to evaluate the benefit and efficacy of individualized self-efficacy coaching for women with high-risk early breast cancer. In total, ...
Detailed Description
Breast cancer represents the leading cause of cancer in women in Switzerland with around 6,000 newly diagnosed cases per year. Beside the therapy- and cancer-associated somatic illness, about one thir...
Eligibility Criteria
Inclusion
- Written and signed informed consent
- Histologically confirmed early breast cancer
- High risk patients, defined as T≥3 and/or N+ and/or G3 and/or Triple-Negative Breast Cancer (TNBC; PgR-/ER-/HER2-) at primary diagnosis
- Eligible for systemic neo-adjuvant or adjuvant therapy
- Age ≥ 18 years
- ECOG 0-2
- Expected follow-up care at site for at least 5 years
- Expected adherence to observation and questionnaire assessment (Group A and B) as well as to study intervention (Group A)
- Anti-cancer therapy and follow-up care according to the established guidelines
- Fluent in written and spoken German language
Exclusion
- Not eligible for systemic neo-adjuvant or adjuvant treatment according to the established guidelines
- Previous systemic anti-neoplastic therapy
- Resection \>R0 for adjuvant patients
- Metastases
- Patients who decline systemic therapy according to established guidelines for personal reasons
- Inflammatory breast cancer, sarcomas, M. Paget
- Presence of other primary tumors within the last 5 years, except for appropriately treated, controlled, basal-cell carcinoma and cervical cancer in situ
- Not controlled, severe, life-threatening, or prognostic unfavorable comorbidities
- Pregnancy, lactation
- Indication of a severe depression/anxiety disorder at baseline (PHQ 9 Score ≥15 and/or GAD-7 Score ≥15 at baseline)
- Participation in other (non-)interventional studies or tumor registries
- Male patients
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03478384
Start Date
March 16 2018
End Date
November 22 2018
Last Update
October 27 2022
Active Locations (6)
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1
Tumorzentrum ZeTuP Rapperswil-Jona
Rapperswil-Jona, Canton of St. Gallen, Switzerland, 8640
2
Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital
Bern, Switzerland
3
Spital Thurgau AG - Kantonsspital Frauenfeld
Frauenfeld, Switzerland
4
Hirslanden Klinik St. Anna
Lucerne, Switzerland