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| Name | Class |
|---|---|
| Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator |
| |
| Usual Care + Complementary Medicine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized complementary medicine treatment | Other | An individual treatment plan will be made for each patient that includes one to all of the following treatments: acupuncture, traditional Chinese herbal medicine, enzyme therapy, nutrition advise, Healing Touch, homoeopathy, hyperthermia treatment, infusions, laser therapy, lymphatic drainage, manual therapy, mistel therapy, neural therapy, orthomolecular therapy, osteopathy, phytotherapy, shiatsu |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B) | 3 months | |
| Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia M Witt, Prof. Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meran Hospital - Dienst fuer Komplementaermedizin | Meran | 39012 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25555830 | Result | Witt 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Individualized usual care | Other | Patients get usual care from their general practitioners/specialized physicians |
|
| 3, 6 months |
| Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 3, 6 months |
| Pain, quality of sleep, and nausea (single items of the FACT-B) | 3, 6 months |
| Functional Assessment of Chronic Illness Therapy-Fatigue | 3, 6 months |
| Survival without relapse | 6 months |
| Quality of Life (SF-12 Health Survey) | 3, 6 months |
| Undesirable Effects and Interactions | 6 months |
| Goal Attainment Scale | This outcome measures will only be assessed in the complementary medicine arm | 3 months |
| Used complementary Therapies and their frequency | This will only be assessed in the complementary medicine arm | 6 months |
| Expectations at Baseline | This will only be assessed in the complementary medicine group | Baseline |
| Satisfaction and patient-reported effectiveness | This will only be assessed in the complementary medicine arm | 3, 6 months |
| Survival | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |