Life Quality and Mental State in Patients With Breast Cancer

Study Overview
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Brief Summary
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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

Official Title
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Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Individualized complementary medicine treatment
* Other: Individualized usual care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br> | Other: Individualized usual care<br>* Patients get usual care from their general practitioners/specialized physicians<br>|
| Active Comparator: Usual Care + Complementary Medicine<br> | Other: Individualized complementary medicine treatment<br>* 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<br>Other: Individualized usual care<br>* Patients get usual care from their general practitioners/specialized physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |