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Completed

NCT Number: NCT01458457

Life Quality and Mental State in Patients With Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Meran Hospital - Dienst fuer Komplementaermedizin

Meran, 39012, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized complementary medicine treatment

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

Other

Patients get usual care from their general practitioners/specialized physicians

Primary outcomes

  1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 6 months

Secondary outcomes

  1. Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)

    Time frame: 3 months

  2. 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. Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 3, 6 months

  4. Pain, quality of sleep, and nausea (single items of the FACT-B)

    Time frame: 3, 6 months

  5. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: 3, 6 months

  6. Survival without relapse

    Time frame: 6 months

  7. Quality of Life (SF-12 Health Survey)

    Time frame: 3, 6 months

  8. Undesirable Effects and Interactions

    Time frame: 6 months

  9. Goal Attainment Scale

    Time frame: 3 months

    This outcome measures will only be assessed in the complementary medicine arm

  10. Used complementary Therapies and their frequency

    Time frame: 6 months

    This will only be assessed in the complementary medicine arm

  11. Expectations at Baseline

    Time frame: Baseline

    This will only be assessed in the complementary medicine group

  12. Satisfaction and patient-reported effectiveness

    Time frame: 3, 6 months

    This will only be assessed in the complementary medicine arm

  13. Survival

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy

Registry information

Official study title

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

Acronym: BBK

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 24, 2011
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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