Clinical trial · Interventional
Self-efficacy Coaching for Women With Breast Cancer
Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, 6 sites will be assigned 1:1 to either the experimental arm (Group A) or the control arm (Group B). The controlled site assignment will assure a balanced site-specific QoL between both groups at baseline. All patients will be medically treated according to guidelines. The experimental Group A will in addition receive regular self-efficacy coaching.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Coaching group
- description
- Patient coaching
- interventionNames
- Behavioral: Patient coaching
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control group - no additional coaching provided
Primary outcomes (1)
- measure
- Overall perceived self-efficacy
- timeFrame
- The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
- description
- Overall perceived self-efficacy is measured by a specifically developed questionnaire (questionnaire SWE). Analysis will be descriptive, separate for each group and performed according to the analysis manual. A difference between the groups is defined as 10% difference in median between the groups. The scale ranges from 10 to 40 points. The higher the score, the higher is perceived self-efficacy of the patient.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written and signed informed consent 2. Histologically confirmed early breast cancer 3. 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 4. Eligible for systemic neo-adjuvant or adjuvant therapy 5. Age ≥ 18 years 6. ECOG 0-2 7. Expected follow-up care at site for at least 5 years 8. Expected adherence to observation and questionnaire assessment (Group A and B) as well as to study intervention (Group A) 9. Anti-cancer therapy and follow-up care according to the established guidelines 10. Fluent in written and spoken German language Exclusion Criteria: 1. Not eligible for systemic neo-adjuvant or adjuvant treatment according to the established guidelines 2. Previous systemic anti-neoplastic therapy 3. Resection \>R0 for adjuvant patients 4. Metastases 5. Patients who decline systemic therapy according to established guidelines for personal reasons 6. Inflammatory breast cancer, sarcomas, M. Paget 7. Presence of other primary tumors within the last 5 years, except for appropriately treated, controlled, basal-cell carcinoma and cervical cancer in situ 8. Not controlled, severe, life-threatening, or prognostic unfavorable comorbidities 9. Pregnancy, lactation 10. Indication of a severe depression/anxiety disorder at baseline (PHQ 9 Score ≥15 and/or GAD-7 Score ≥15 at baseline) 11. Participation in other (non-)interventional studies or tumor registries 12. Male patients
References
Publications (0)
Data not yet available