Clinical trial · Interventional
Life Quality and Mental State in Patients With Breast Cancer
Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study
NCT01458457CI-TRIAL-00016877BBKcompletedPhase 4ClinicalTrials.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)
Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized complementary medicine treatment | Other | — | UNRESOLVED |
| Individualized usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- interventionNames
- Other: Individualized usual care
- type
- ACTIVE_COMPARATOR
- label
- Usual Care + Complementary Medicine
- interventionNames
- Other: Individualized complementary medicine treatment
- Other: Individualized usual care
Primary outcomes (1)
- measure
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
- timeFrame
- 6 months
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * diagnosed breast cancer * current usual care treatment * willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group * informed consent Exclusion Criteria: * complementary treatment at the Hospital Meran in the last 6 months * no German or Italian language ability * participation in other study
References
Publications (1)
- RESULTWitt CM, Ausserer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schutzler L. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat. 2015 Jan;149(2):449-60. doi: 10.1007/s10549-014-3249-3. Epub 2015 Jan 3. PMID 25555830