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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Mind body medicine day care clinic; Other: Usual care

• Registration Number: NCT02669576
• Lead Sponsor: Universität Duisburg-Essen

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-01
• Primary Completion: 2022-03
• Study Completion: 2022-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind body medicine day care clinic	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
Usual care	Usual care	Patients continue usual care by their practitioner

Primary Outcome Measures

Name	Time	Method
Menopausal symptoms	week 11	Menopause Rating Scale (MRS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Evang. Kliniken Essen-Mitte; 🇩🇪 Essen, NRW, Germany