- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874598
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer (EOMI)
May 21, 2021 updated by: Dr. med. Petra Voiss, Universität Duisburg-Essen
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer.
It will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved.
In addition, a proinflammatory cytokine will be meassured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Essen, NRW, Germany, 45276
- Kliniken Essen-Mitte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histological diagnosed non-metastatic breast CAs (TNM stage I-III)
- Existing insomnia (difficulty falling asleep or sleeping through on at least 3 days per week for at least 3 months) according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).
- willingness to participate in the study (at least 8 out of 10 treatments)
- Signed informed consent
Exclusion Criteria:
- Ongoing or planned chemotherapy, radiation, follow-up treatment or reconstructive plastic surgery during the study period
- Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
- Pregnancy
- Participation in other clinical trials with behavioural, psychological or complementary medical interventions during the study period
- Regular use of barbiturates, antidepressants or other sleep-inducing drugs, drug abusus, alcoholism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Psychoeducation
|
Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
|
Experimental: Ear acupuncture
|
Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: week 0
|
Pittsburgh Sleep Quality Index (PSQI).
The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate.
The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis.
The question whether a bed-partner or roommate is present is not included in qualitative analysis as well.
The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction).
Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale.
The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality.
A cut-off score of 5 indicates a "poor" sleeper.
|
week 0
|
Sleep Quality
Time Frame: week 5
|
Pittsburgh Sleep Quality Index (PSQI).
The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate.
The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis.
The question whether a bed-partner or roommate is present is not included in qualitative analysis as well.
The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction).
Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale.
The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality.
A cut-off score of 5 indicates a "poor" sleeper.
|
week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life in cancer patients
Time Frame: week 0
|
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
|
week 0
|
Quality of Life in cancer patients
Time Frame: week 5
|
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
|
week 5
|
Quality of Life in cancer patients
Time Frame: week 17
|
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
|
week 17
|
Quality of Life in cancer patients
Time Frame: week 29
|
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
|
week 29
|
Fatigue
Time Frame: week 0
|
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
|
week 0
|
Fatigue
Time Frame: week 5
|
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
|
week 5
|
Fatigue
Time Frame: week 17
|
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
|
week 17
|
Fatigue
Time Frame: week 29
|
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
|
week 29
|
Psychological well-being
Time Frame: week 0
|
Hospital Anxiety and Depression Scale (HADS).
It measures the 2 dimensions anxiety and depression.
Scores range from 0 to 21 with higher values indicate higher distress.
Values of >8 indicate potential subclinical anxiety or depressive disorders.
|
week 0
|
Psychological well-being
Time Frame: week 5
|
Hospital Anxiety and Depression Scale (HADS).
It measures the 2 dimensions anxiety and depression.
Scores range from 0 to 21 with higher values indicate higher distress.
Values of >8 indicate potential subclinical anxiety or depressive disorders.
|
week 5
|
Psychological well-being
Time Frame: week 17
|
Hospital Anxiety and Depression Scale (HADS).
It measures the 2 dimensions anxiety and depression.
Scores range from 0 to 21 with higher values indicate higher distress.
Values of >8 indicate potential subclinical anxiety or depressive disorders.
|
week 17
|
Psychological well-being
Time Frame: week 29
|
Hospital Anxiety and Depression Scale (HADS).
It measures the 2 dimensions anxiety and depression.
Scores range from 0 to 21 with higher values indicate higher distress.
Values of >8 indicate potential subclinical anxiety or depressive disorders.
|
week 29
|
Stress
Time Frame: week 0
|
Perceived Stress Scale (PSS).
Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale.
For the summed items (range from 0 to 40) a higher total score indicates greater stress.
|
week 0
|
Stress
Time Frame: week 5
|
Perceived Stress Scale (PSS).
Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale.
For the summed items (range from 0 to 40) a higher total score indicates greater stress.
|
week 5
|
Stress
Time Frame: week 17
|
Perceived Stress Scale (PSS).
Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale.
For the summed items (range from 0 to 40) a higher total score indicates greater stress.
|
week 17
|
Stress
Time Frame: week 29
|
Perceived Stress Scale (PSS).
Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale.
For the summed items (range from 0 to 40) a higher total score indicates greater stress.
|
week 29
|
Adverse Events
Time Frame: week 5
|
Number of patients with adverse events and type of the adverse event
|
week 5
|
Adverse Events
Time Frame: week 17
|
Number of patients with adverse events and type of the adverse event
|
week 17
|
Change in proinflammatory cytokine
Time Frame: week 0
|
Interleukin-6
|
week 0
|
Change in proinflammatory cytokine
Time Frame: week 5
|
Interleukin-6
|
week 5
|
Expectation
Time Frame: week 0
|
Visual Analogue Scale (VAS).
The Visual Analogue Scale is a continuous measurement device on which the degree of agreement is indicated by a cross between two end points.
We define the end points of the Visual Analalogue Scale for expectations concerning treatment as "expecting the treatment to be not sucessfull at al" and "expecting the treatment to be extremely successful.
|
week 0
|
Sleep Quality
Time Frame: week 17
|
Pittsburgh Sleep Quality Index (PSQI).
The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate.
The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis.
The question whether a bed-partner or roommate is present is not included in qualitative analysis as well.
The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction).
Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale.
The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality.
A cut-off score of 5 indicates a "poor" sleeper.
|
week 17
|
Sleep Quality
Time Frame: week 29
|
Pittsburgh Sleep Quality Index (PSQI).
The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate.
The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis.
The question whether a bed-partner or roommate is present is not included in qualitative analysis as well.
The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction).
Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale.
The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality.
A cut-off score of 5 indicates a "poor" sleeper.
|
week 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gustav Dobos, Prof. MD, University of Duisburg Essen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2019
Primary Completion (Actual)
February 19, 2020
Study Completion (Actual)
February 19, 2020
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 21, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-8214-BO
- KVC 0/100/2018 (Other Grant/Funding Number: Karl und Veronica Carstens-Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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