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

This study has been completed.
Sponsor:
Collaborator:
Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01458457
First received: October 21, 2011
Last updated: January 14, 2013
Last verified: January 2013
  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: 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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Pain, quality of sleep, and nausea (single items of the FACT-B) [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Survival without relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life (SF-12 Health Survey) [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
  • Undesirable Effects and Interactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Goal Attainment Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This outcome measures will only be assessed in the complementary medicine arm

  • Used complementary Therapies and their frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This will only be assessed in the complementary medicine arm

  • Expectations at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This will only be assessed in the complementary medicine group

  • Satisfaction and patient-reported effectiveness [ Time Frame: 3, 6 months ] [ Designated as safety issue: No ]
    This will only be assessed in the complementary medicine arm

  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 275
Study Start Date: May 2011
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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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. Charité University Medical Center, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01458457     History of Changes
Other Study ID Numbers: BBK
Study First Received: October 21, 2011
Last Updated: January 14, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014