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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02669576

Acronym

ENDOTK

Enrollment

Registered

2016-02-01

Start date

2016-01-31

Completion date

2022-05-31

Last updated

2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, meopausal syptoms, mind body medecine, yoga, acupuncture

Brief 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.

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.

Interventions

BEHAVIORALMind 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

OTHERUsual care

Patients continue usual care by their practitioner

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Menopausal symptoms	week 11	Menopause Rating Scale (MRS)

Secondary

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

Other

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026