NCT02669576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

6.2 years

First QC Date

January 21, 2016

Last Update Submit

December 5, 2022

Conditions

Breast Cancer

Keywords

Breast cancermeopausal syptomsmind body medecineyogaacupuncture

Outcome Measures

Primary Outcomes (1)

  • Menopausal symptoms

    Menopause Rating Scale (MRS)

    week 11

Secondary Outcomes (15)

  • General health-related quality of life

    week 11

  • Spiritual health-related quality of life

    week 11

  • Fatigue

    week 11

  • Mental wellbeing

    week 11

  • Stress

    week 11

  • +10 more secondary outcomes

Other Outcomes (4)

  • Mindfulness

    week 11

  • Social Support

    week 11

  • Expectation

    week 0

  • +1 more other outcomes

Study Arms (2)

Mind body medicine day care clinic

EXPERIMENTAL

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

Behavioral: Mind body medicine day care clinic

Usual care

OTHER

Patients continue usual care by their practitioner

Other: Usual care

Interventions

Mind body medicine day care clinicBEHAVIORAL

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

Mind body medicine day care clinic
Usual careOTHER

Patients continue usual care by their practitioner

Usual care

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gustav Dobos, Prof. MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 1, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)