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

Universität Duisburg-Essen

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Mind body medicine day care clinic; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02669576

15-6578-BO

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Mind body medicine day care clinic

Experimental group

Description:

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

Treatment:

Behavioral: Mind body medicine day care clinic

Usual care

Other group

Description:

Patients continue usual care by their practitioner

Treatment:

Other: Usual care