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Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer (EOMI)

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ClinicalTrials.gov Identifier: NCT03874598
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Karl and Veronica Carstens Foundation
Information provided by (Responsible Party):
Dr. med. Petra Voiss, Universität Duisburg-Essen

Brief 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. In addition, a proinflammatory cytokine will be meassured.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Procedure: Ear acupuncture Behavioral: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ear acupuncture Procedure: Ear acupuncture
Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Active Comparator: Psychoeducation Behavioral: Psychoeducation
Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Quality of Life in cancer patients [ Time Frame: week 0 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

  2. Quality of Life in cancer patients [ Time Frame: week 5 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

  3. Quality of Life in cancer patients [ Time Frame: week 12 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

  4. Quality of Life in cancer patients [ Time Frame: week 24 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

  5. Fatigue [ Time Frame: week 0 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

  6. Fatigue [ Time Frame: week 5 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

  7. Fatigue [ Time Frame: week 12 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

  8. Fatigue [ Time Frame: week 24 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

  9. 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.

  10. 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.

  11. Psychological well-being [ Time Frame: week 12 ]
    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.

  12. Psychological well-being [ Time Frame: week 24 ]
    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.

  13. 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.

  14. 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.

  15. Stress [ Time Frame: week 12 ]
    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.

  16. Stress [ Time Frame: week 24 ]
    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.

  17. Adverse Events [ Time Frame: week 5 ]
    Number of patients with adverse events and type of the adverse event

  18. Adverse Events [ Time Frame: week 12 ]
    Number of patients with adverse events and type of the adverse event

  19. Change in proinflammatory cytokine [ Time Frame: week 0 ]
    Interleukin-6

  20. Change in proinflammatory cytokine [ Time Frame: week 5 ]
    Interleukin-6

  21. 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.

  22. Sleep Quality [ Time Frame: week 12 ]
    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. Sleep Quality [ Time Frame: week 24 ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874598


Contacts
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Contact: Melanie Desiree Höxtermann, MSc 004920117425537 M.Hoextermann@kem-med.com
Contact: Holger Cramer, PhD 004920117425015 h.cramer@kem-med.com

Locations
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Germany
Kliniken Essen-Mitte Recruiting
Essen, NRW, Germany, 45276
Contact: Gustav Dobos, Prof. MD    004920117425001    g.dobos@kem-med.com   
Sub-Investigator: Melanie Desiree Höxtermann, MSc         
Principal Investigator: Petra Voiss, MD         
Sub-Investigator: Holger Cramer, PhD         
Sponsors and Collaborators
Universität Duisburg-Essen
Karl and Veronica Carstens Foundation
Investigators
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Study Director: Gustav Dobos, Prof. MD University of Duisburg Essen

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Responsible Party: Dr. med. Petra Voiss, MD, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03874598     History of Changes
Other Study ID Numbers: 18-8214-BO
KVC 0/100/2018 ( Other Grant/Funding Number: Karl und Veronica Carstens-Foundation )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. med. Petra Voiss, Universität Duisburg-Essen:
Sleep Initiation and Maintenance Disorders
Acupuncture, Ear
Cytokines
Breast Neoplasm

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases