Breast CancerENDOTKNCT02669576
Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy
A study testing Mind body medicine day care clinic in people with Breast Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mind body medicine day care clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45276
About this study
Official title: Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.
This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Mind body medicine day care clinic, Usual care
- Keywords
- Breast cancer, meopausal syptoms, mind body medecine, yoga, acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind body medicine day care clinicBehavioural
Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
Usual careOther
Patients continue usual care by their practitioner
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mind body medicine day care clinic |
| Usual care | Other | Patients continue usual care by their practitioner Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptoms
Menopause Rating Scale (MRS)
Measured: week 11
Secondary outcomes (15)
General health-related quality of life
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
Measured: week 11
Spiritual health-related quality of life
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
Measured: week 11
Fatigue
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
Measured: week 11
Mental wellbeing
Hospital Anxiety and Depression Scale (HADS)
Measured: week 11
Stress
Perceived Stress Scale (PSS)
Measured: week 11
Compliance
Medication Adherence Report Scale (MARS)
Measured: week 11
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: week 11
Menopausal smptoms
Menopause Rating Scale (MRS)
Measured: week 23
Genaeral health-related quality of life
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
Measured: week 23
Spiritual health-related quality of life
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
Measured: week 23
Fatigue
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
Measured: week 23
Mental wellbeing
Hospital Anxiety and Depression Scale (HADS)
Measured: week 23
Stress
Perceived Stress Scale (PSS)
Measured: week 23
Compliance
Medication Adherence Report Scale (MARS)
Measured: week 23
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669576
- Sponsor's protocol ID
- 15-6578-BO
- Acronym
- ENDOTK
- Status last verified
- Dec 2022
- First submitted
- 21 Jan 2016
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02669576
- Acronym / sponsor ID
- ENDOTK / 15-6578-BO
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, meopausal syptoms, mind body medecine, yoga, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind body medicine day care clinic | Experimental | Behavioral: Mind body medicine day care clinicPatients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education |
| Usual care | Other | Other: Usual carePatients continue usual care by their practitioner |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind body medicine day care clinicPatients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education | Behavioural | Mind body medicine day care clinic |
| Usual carePatients continue usual care by their practitioner | Other | Usual care |
Primary outcome
Menopausal symptoms
Time frame: week 11
Menopause Rating Scale (MRS)
15 secondary outcomes
General health-related quality of life
Time frame: week 11
Spiritual health-related quality of life
Time frame: week 11
Fatigue
Time frame: week 11
Mental wellbeing
Time frame: week 11
Stress
Time frame: week 11
Compliance
Time frame: week 11
Adverse events
Time frame: week 11
Menopausal smptoms
Time frame: week 23
Genaeral health-related quality of life
Time frame: week 23
Spiritual health-related quality of life
Time frame: week 23
Fatigue
Time frame: week 23
Mental wellbeing
Time frame: week 23
Stress
Time frame: week 23
Compliance
Time frame: week 23
Adverse Events
Time frame: week 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof. MD study director
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind body medicine day care clinic in people with Breast Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal symptoms (time frame: week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.