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Completed

NCT Number: NCT02669576

Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy

This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

About this study

Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histological diagnosed breast cancer (Stage I-III), no metastases
  • Current endocrine therapy (minimum 3 months)
  • Score of 9 or greater on the Menopausal Rating Scale (MRS)
  • Signed informed consent

Exclusion criteria

  • Severe other somatic or psychiatric comorbidity
  • Pregnancy
  • Planned or existing chemotherapy, radiation or other cure treatment
  • Participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.

Treatment and study plan

Mind body medicine day care clinic

Behavioral

Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education

Usual Care

Other

Patients continue usual care by their practitioner

Primary outcomes

  1. Menopausal symptoms

    Time frame: week 11

    Menopause Rating Scale (MRS)

Secondary outcomes

  1. General health-related quality of life

    Time frame: week 11

    Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)

  2. Spiritual health-related quality of life

    Time frame: week 11

    Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)

  3. Fatigue

    Time frame: week 11

    Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)

  4. Mental wellbeing

    Time frame: week 11

    Hospital Anxiety and Depression Scale (HADS)

  5. Stress

    Time frame: week 11

    Perceived Stress Scale (PSS)

  6. Compliance

    Time frame: week 11

    Medication Adherence Report Scale (MARS)

  7. Adverse events

    Time frame: week 11

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  8. Menopausal smptoms

    Time frame: week 23

    Menopause Rating Scale (MRS)

  9. Genaeral health-related quality of life

    Time frame: week 23

    Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)

  10. Spiritual health-related quality of life

    Time frame: week 23

    Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)

  11. Fatigue

    Time frame: week 23

    Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)

  12. Mental wellbeing

    Time frame: week 23

    Hospital Anxiety and Depression Scale (HADS)

  13. Stress

    Time frame: week 23

    Perceived Stress Scale (PSS)

  14. Compliance

    Time frame: week 23

    Medication Adherence Report Scale (MARS)

  15. Adverse Events

    Time frame: week 23

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Other outcomes

  1. Mindfulness

    Time frame: week 11

    Conscious Presence and Self Control Scale (CPSC)

  2. Social Support

    Time frame: week 11

    Berlin Social Support Scale (BSSS)

  3. Expectation

    Time frame: week 0

    Visual Analogue Scale (VAS)

  4. Statisfaction

    Time frame: week 11

    Client Satisfaction Questionnaire (CSQ)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.

Acronym: ENDOTK

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2016
Registry last updated
Dec 6, 2022

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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