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

February 13, 2015 updated by: Claudia M. Witt, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Meran, Italy, 39012
        • Meran Hospital - Dienst fuer Komplementaermedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 usual care
Patients get usual care from their general practitioners/specialized physicians
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 6 months
6 months
Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)
Time Frame: 3 months
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
3, 6 months
Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: 3, 6 months
3, 6 months
Pain, quality of sleep, and nausea (single items of the FACT-B)
Time Frame: 3, 6 months
3, 6 months
Functional Assessment of Chronic Illness Therapy-Fatigue
Time Frame: 3, 6 months
3, 6 months
Survival without relapse
Time Frame: 6 months
6 months
Quality of Life (SF-12 Health Survey)
Time Frame: 3, 6 months
3, 6 months
Undesirable Effects and Interactions
Time Frame: 6 months
6 months
Goal Attainment Scale
Time Frame: 3 months
This outcome measures will only be assessed in the complementary medicine arm
3 months
Used complementary Therapies and their frequency
Time Frame: 6 months
This will only be assessed in the complementary medicine arm
6 months
Expectations at Baseline
Time Frame: Baseline
This will only be assessed in the complementary medicine group
Baseline
Satisfaction and patient-reported effectiveness
Time Frame: 3, 6 months
This will only be assessed in the complementary medicine arm
3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy

Investigators

  • Principal Investigator: Claudia M Witt, Prof. Dr. med., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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