Clinical trial · Interventional
Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy
Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy: an Observational Study
NCT03868865CI-TRIAL-00037530completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the study was to evaluate a new integrative day-care clinic concept for breast cancer patients receiving chemotherapy. This is an explorative pilot study. Therefore, all outcomes are analyzed exploratively.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Mind-Body-Medicine | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Integrative mind-body-medicine group program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Integrative mind-body-medicine group program
- description
- The 66 hour program encompasses mindfulness training, yoga, moderate exercise, nutrition, naturopathic self-help strategies, cognitive restructuring and acupuncture for the management of side effects caused by chemotherapy.
- interventionNames
- Behavioral: Integrative mind-body-medicine group program
Primary outcomes (6)
- measure
- European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)
- timeFrame
- up to 26 weeks (depending on chemotherapy regime)
- description
- Besides the global quality of life subscale, this instrument assesses five functional domains of quality of life: physical, role, emotional, cognitive, and social function. Symptom scales further assess fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties. Scores of all subscales range from 0 to 100, while a higher score represents a better level of functioning or a worse amount of symptoms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * curative malignancy (breast cancer of TNM (T: primary tumor, N: regional nodes, M: metastasis) staging I-III) * receiving chemotherapy * at least 18 years old * written informed consent * willing and physically/mentally able to participate in a six hours day care clinic program eleven times during chemotherapy. Exclusion Criteria: * insufficient knowledge of the German language * physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.
References
Publications (0)
Data not yet available
No reference posted for this study.