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

December 5, 2022 updated by: Heidemarie Haller, Universität Duisburg-Essen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

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

  • Germany
    • NRW
      • Essen, NRW, Germany, 45276
        • Evang. Kliniken Essen-Mitte

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mind body medicine day care clinic
Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
Behavioral: Mind body medicine day care clinic
Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
Other: Usual care
Patients continue usual care by their practitioner
Other: Usual care
Patients continue usual care by their practitioner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopausal symptoms
Time Frame: week 11
Menopause Rating Scale (MRS)
week 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General health-related quality of life
Time Frame: week 11
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
week 11
Spiritual health-related quality of life
Time Frame: week 11
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
week 11
Fatigue
Time Frame: week 11
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
week 11
Mental wellbeing
Time Frame: week 11
Hospital Anxiety and Depression Scale (HADS)
week 11
Stress
Time Frame: week 11
Perceived Stress Scale (PSS)
week 11
Compliance
Time Frame: week 11
Medication Adherence Report Scale (MARS)
week 11
Adverse events
Time Frame: week 11
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
week 11
Menopausal smptoms
Time Frame: week 23
Menopause Rating Scale (MRS)
week 23
Genaeral health-related quality of life
Time Frame: week 23
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
week 23
Spiritual health-related quality of life
Time Frame: week 23
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
week 23
Fatigue
Time Frame: week 23
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
week 23
Mental wellbeing
Time Frame: week 23
Hospital Anxiety and Depression Scale (HADS)
week 23
Stress
Time Frame: week 23
Perceived Stress Scale (PSS)
week 23
Compliance
Time Frame: week 23
Medication Adherence Report Scale (MARS)
week 23
Adverse Events
Time Frame: week 23
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
week 23

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness
Time Frame: week 11
Conscious Presence and Self Control Scale (CPSC)
week 11
Social Support
Time Frame: week 11
Berlin Social Support Scale (BSSS)
week 11
Expectation
Time Frame: week 0
Visual Analogue Scale (VAS)
week 0
Statisfaction
Time Frame: week 11
Client Satisfaction Questionnaire (CSQ)
week 11

Collaborators and Investigators

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

Sponsor

Universität Duisburg-Essen

Investigators

  • Study Director: Gustav Dobos, Prof. MD, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

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 (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-6578-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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