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Life Quality and Mental State in Patients With Breast Cancer (BBK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458457
First Posted: October 24, 2011
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
  Purpose
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

Condition Intervention Phase
Breast Cancer Other: Individualized complementary medicine treatment Other: Individualized usual care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study

Resource links provided by NLM:


Further study details as provided by Claudia M. Witt, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B) [ Time Frame: 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) [ Time Frame: 3, 6 months ]
  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 3, 6 months ]
  • Pain, quality of sleep, and nausea (single items of the FACT-B) [ Time Frame: 3, 6 months ]
  • Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: 3, 6 months ]
  • Survival without relapse [ Time Frame: 6 months ]
  • Quality of Life (SF-12 Health Survey) [ Time Frame: 3, 6 months ]
  • Undesirable Effects and Interactions [ Time Frame: 6 months ]
  • Goal Attainment Scale [ Time Frame: 3 months ]
    This outcome measures will only be assessed in the complementary medicine arm

  • Used complementary Therapies and their frequency [ Time Frame: 6 months ]
    This will only be assessed in the complementary medicine arm

  • Expectations at Baseline [ Time Frame: Baseline ]
    This will only be assessed in the complementary medicine group

  • Satisfaction and patient-reported effectiveness [ Time Frame: 3, 6 months ]
    This will only be assessed in the complementary medicine arm

  • Survival [ Time Frame: 6 months ]

Enrollment: 275
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care Other: Individualized usual care
Patients get usual care from their general practitioners/specialized physicians
Active Comparator: Usual Care + Complementary Medicine Other: 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
Other: Individualized usual care
Patients get usual care from their general practitioners/specialized physicians

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458457


Locations
Italy
Meran Hospital - Dienst fuer Komplementaermedizin
Meran, Italy, 39012
Sponsors and Collaborators
Charite University, Berlin, Germany
Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
Investigators
Principal Investigator: Claudia M Witt, Prof. Dr. med. Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01458457     History of Changes
Other Study ID Numbers: BBK
First Submitted: October 21, 2011
First Posted: October 24, 2011
Last Update Posted: February 16, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases