Breast NeoplasmEOMINCT03874598
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer
A study testing Ear acupuncture and Psychoeducation in people with Breast Neoplasm, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Ear acupuncture and Psychoeducation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jun 2019to 19 Feb 2020
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Neoplasm
- Being tested
- Ear acupuncture, Psychoeducation
- Keywords
- Sleep Initiation and Maintenance Disorders, Acupuncture, Ear, Cytokines, Breast Neoplasm
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupunctureProcedure or surgery
Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.
PsychoeducationBehavioural
Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Ear acupuncture | Experimental | Not described Receives: Procedure: Ear acupuncture |
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
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.
Measured: week 0
Sleep Quality
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.
Measured: week 5
Secondary outcomes (23)
Quality of Life in cancer patients
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
Measured: week 0
Quality of Life in cancer patients
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
Measured: week 5
Quality of Life in cancer patients
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
Measured: week 17
Quality of Life in cancer patients
Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
Measured: week 29
Fatigue
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
Measured: week 0
Fatigue
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
Measured: week 5
Fatigue
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
Measured: week 17
Fatigue
Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
Measured: week 29
Psychological well-being
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.
Measured: week 0
Psychological well-being
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.
Measured: week 5
Psychological well-being
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.
Measured: week 17
Psychological well-being
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.
Measured: week 29
Stress
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.
Measured: week 0
Stress
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.
Measured: week 5
Stress
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.
Measured: week 17
Stress
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.
Measured: week 29
Adverse Events
Number of patients with adverse events and type of the adverse event
Measured: week 5
Adverse Events
Number of patients with adverse events and type of the adverse event
Measured: week 17
Change in proinflammatory cytokine
Interleukin-6
Measured: week 0
Change in proinflammatory cytokine
Interleukin-6
Measured: week 5
Expectation
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.
Measured: week 0
Sleep Quality
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.
Measured: week 17
Sleep Quality
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.
Measured: week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start12 Jun 2019
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Principal investigator, Dr. med. Petra Voiss, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, University of Duisburg Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874598
- Sponsor's protocol ID
- 18-8214-BO
- Other IDs
- KVC 0/100/2018
- Acronym
- EOMI
- Status last verified
- May 2021
- First submitted
- 13 Mar 2019
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03874598
- Acronym / sponsor ID
- EOMI / 18-8214-BO
- Conditions
- Breast Neoplasm
- Keywords
- Sleep Initiation and Maintenance Disorders, Acupuncture, Ear, Cytokines, Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ear acupuncture | Experimental | Procedure: Ear acupuncture |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
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 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Ear acupuncturePatients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture. | Procedure or surgery | Ear acupuncture |
| PsychoeducationPatients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour. | Behavioural | Psychoeducation |
Primary outcome
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.
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.
23 secondary outcomes
Quality of Life in cancer patients
Time frame: week 0
Quality of Life in cancer patients
Time frame: week 5
Quality of Life in cancer patients
Time frame: week 17
Quality of Life in cancer patients
Time frame: week 29
Fatigue
Time frame: week 0
Fatigue
Time frame: week 5
Fatigue
Time frame: week 17
Fatigue
Time frame: week 29
Psychological well-being
Time frame: week 0
Psychological well-being
Time frame: week 5
Psychological well-being
Time frame: week 17
Psychological well-being
Time frame: week 29
Stress
Time frame: week 0
Stress
Time frame: week 5
Stress
Time frame: week 17
Stress
Time frame: week 29
Adverse Events
Time frame: week 5
Adverse Events
Time frame: week 17
Change in proinflammatory cytokine
Time frame: week 0
Change in proinflammatory cytokine
Time frame: week 5
Expectation
Time frame: week 0
Sleep Quality
Time frame: week 17
Sleep Quality
Time frame: week 29
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 24 May 2021.
- 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
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 Ear acupuncture and Psychoeducation in people with Breast Neoplasm, 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 5 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 24 May 2021. 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?
Sleep Quality (time frame: week 0). The study lists 2 primary outcomes in all. 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 24 May 2021.