Breast Cancer
Conditions
Brief summary
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
Interventions
OTHERIndividualized complementary medicine treatment
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
OTHERIndividualized usual care
Patients get usual care from their general practitioners/specialized physicians
Sponsors
Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being) | 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 | — |
| Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B) | 3 months | — |
| Goal Attainment Scale | 3 months | This outcome measures will only be assessed in the complementary medicine arm |
| Used complementary Therapies and their frequency | 6 months | This will only be assessed in the complementary medicine arm |
| Expectations at Baseline | Baseline | This will only be assessed in the complementary medicine group |
| Satisfaction and patient-reported effectiveness | 3, 6 months | This will only be assessed in the complementary medicine arm |
| Survival | 6 months | — |
| Undesirable Effects and Interactions | 6 months | — |
Countries
Italy
Outcome results
None listed