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

• ClinicalTrials.gov Identifier: NCT03874598
• Recruitment Status: Completed
• First Posted: March 14, 2019
• Last Update Posted: May 24, 2021
• Sponsor: Universität Duisburg-Essen
• Collaborator: Karl and Veronica Carstens Foundation
• Information provided by (Responsible Party): Dr. med. Petra Voiss, Universität Duisburg-Essen

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: June 12, 2019
• Actual Primary Completion Date: February 19, 2020
• Actual Study Completion Date: February 19, 2020

Arms and Interventions

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.

Outcome Measures

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 17 ]
   Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)
4. Quality of Life in cancer patients [ Time Frame: week 29 ]
   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 17 ]
   Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)
8. Fatigue [ Time Frame: week 29 ]
   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 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.
12. 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.
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 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.
16. 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.
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 17 ]
    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 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.
23. 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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Germany

Kliniken Essen-Mitte

Essen, NRW, Germany, 45276

Sponsors and Collaborators

Universität Duisburg-Essen

Karl and Veronica Carstens Foundation

Investigators

• Study Director: Gustav Dobos, Prof. MD; University of Duisburg Essen

More Information

• Responsible Party: Dr. med. Petra Voiss, MD, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT03874598
• 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
• Last Update Posted: May 24, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Breast Neoplasms; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases