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

NCT ID: NCT02669576

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Mind body medicine day care clinic

Intervention Type BEHAVIORAL

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

Usual care

Patients continue usual care by their practitioner

Group Type OTHER

Usual care

Intervention Type OTHER

Patients continue usual care by their practitioner

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Usual care

Patients continue usual care by their practitioner

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heidemarie Haller

Postdoctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-6578-BO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindfulness for Breast Cancer
NCT02647216 COMPLETED NA