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

Breast Cancer Clinical Trial

— ENDOTK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669576
• Other study ID #: 15-6578-BO
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2022

Study information

• Verified date: December 2022
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Evang. Kliniken Essen-Mitte	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

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