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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

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 22, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Sleep Quality [ Time Frame: week 0 ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Sleep Quality [ Time Frame: week 5 ]
    Pittsburgh Sleep Quality Index (PSQI)
Change History Complete list of historical versions of study NCT03874598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Quality of Life in cancer patients [ Time Frame: week 0 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 5 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 12 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 24 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Fatigue [ Time Frame: week 0 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 5 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 12 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 24 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Adverse Events [ Time Frame: week 5 ]
    Number of patients with adverse events and type of the adverse event
  • Adverse Events [ Time Frame: week 12 ]
    Number of patients with adverse events and type of the adverse event
  • Change in proinflammatory cytokine [ Time Frame: week 0 ]
    Interleukin-6
  • Change in proinflammatory cytokine [ Time Frame: week 5 ]
    Interleukin-6
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Quality of Life in cancer patients [ Time Frame: week 0 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 5 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 12 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Quality of Life in cancer patients [ Time Frame: week 24 ]
    Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
  • Fatigue [ Time Frame: week 0 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 5 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 12 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Fatigue [ Time Frame: week 24 ]
    Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
  • Psychological well-being [ Time Frame: week 0 ]
    Hospital Anxiety and Depression Scale (HADS)
  • Psychological well-being [ Time Frame: week 5 ]
    Hospital Anxiety and Depression Scale (HADS)
  • Psychological well-being [ Time Frame: week 12 ]
    Hospital Anxiety and Depression Scale (HADS)
  • Psychological well-being [ Time Frame: week 24 ]
    Hospital Anxiety and Depression Scale (HADS)
  • Stress [ Time Frame: week 0 ]
    Perceived Stress Scale (PSS)
  • Stress [ Time Frame: week 5 ]
    Perceived Stress Scale (PSS)
  • Stress [ Time Frame: week 12 ]
    Perceived Stress Scale (PSS)
  • Stress [ Time Frame: week 24 ]
    Perceived Stress Scale (PSS)
  • Adverse Events [ Time Frame: week 5 ]
    Number of patients with adverse events and type of the adverse event
  • Adverse Events [ Time Frame: week 12 ]
    Number of patients with adverse events and type of the adverse event
  • Change in proinflammatory cytokine [ Time Frame: week 0 ]
    Interleukin-6
  • Change in proinflammatory cytokine [ Time Frame: week 5 ]
    Interleukin-6
  • Expectation [ Time Frame: week 0 ]
    Visual Analogue Scale (VAS)
  • Sleep Quality [ Time Frame: week 12 ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Sleep Quality [ Time Frame: week 24 ]
    Pittsburgh Sleep Quality Index (PSQI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer
Official Title  ICMJE Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasm
Intervention  ICMJE
  • Procedure: Ear acupuncture
    Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.
  • Behavioral: Psychoeducation
    Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
Study Arms  ICMJE
  • Experimental: Ear acupuncture
    Intervention: Procedure: Ear acupuncture
  • Active Comparator: Psychoeducation
    Intervention: Behavioral: Psychoeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melanie Desiree Höxtermann, MSc 004920117425537 M.Hoextermann@kem-med.com
Contact: Holger Cramer, PhD 004920117425015 h.cramer@kem-med.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874598
Other Study ID Numbers  ICMJE 18-8214-BO
KVC 0/100/2018 ( Other Grant/Funding Number: Karl und Veronica Carstens-Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. med. Petra Voiss, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Karl and Veronica Carstens Foundation
Investigators  ICMJE
Study Director: Gustav Dobos, Prof. MD University of Duisburg Essen
PRS Account Universität Duisburg-Essen
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP