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

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: Breast Cancer
• Intervention / Treatment: Behavioral: Mind body medicine day care clinic; Other: Usual care

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	Menopause Rating Scale (MRS)	week 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General health-related quality of life	Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)	week 11
Spiritual health-related quality of life	Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)	week 11
Fatigue	Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)	week 11
Mental wellbeing	Hospital Anxiety and Depression Scale (HADS)	week 11
Stress	Perceived Stress Scale (PSS)	week 11
Compliance	Medication Adherence Report Scale (MARS)	week 11
Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	week 11
Menopausal smptoms	Menopause Rating Scale (MRS)	week 23
Genaeral health-related quality of life	Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)	week 23
Spiritual health-related quality of life	Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)	week 23
Fatigue	Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)	week 23
Mental wellbeing	Hospital Anxiety and Depression Scale (HADS)	week 23
Stress	Perceived Stress Scale (PSS)	week 23
Compliance	Medication Adherence Report Scale (MARS)	week 23
Adverse Events	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	Conscious Presence and Self Control Scale (CPSC)	week 11
Social Support	Berlin Social Support Scale (BSSS)	week 11
Expectation	Visual Analogue Scale (VAS)	week 0
Statisfaction	Client Satisfaction Questionnaire (CSQ)	week 11

Collaborators and Investigators

• 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

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: Breast cancer; acupuncture; yoga; meopausal syptoms; mind body medecine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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