Life Quality and Mental State in Patients With Breast Cancer

NCT ID: NCT01458457

Last Updated: 2015-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-07-31

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type ACTIVE_COMPARATOR

Individualized usual care

Intervention Type OTHER

Patients get usual care from their general practitioners/specialized physicians

Usual Care + Complementary Medicine

Group Type ACTIVE_COMPARATOR

Individualized complementary medicine treatment

Intervention Type 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

Individualized usual care

Intervention Type OTHER

Patients get usual care from their general practitioners/specialized physicians

Interventions

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Individualized 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

Intervention Type OTHER

Individualized usual care

Patients get usual care from their general practitioners/specialized physicians

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia M Witt, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Meran Hospital - Dienst fuer Komplementaermedizin

Meran, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 25555830 (View on PubMed)

Other Identifiers

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BBK

Identifier Type: -

Identifier Source: org_study_id

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