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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Procedure: Ear acupuncture
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ear acupuncture<br> | Procedure: Ear acupuncture<br>* Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.<br>|
| Active Comparator: Psychoeducation<br> | Behavioral: Psychoeducation<br>* Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in cancer patients | Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B) | week 0 | 
| Quality of Life in cancer patients | Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B) | week 5 | 
| Quality of Life in cancer patients | Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B) | week 17 | 
| Quality of Life in cancer patients | Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B) | week 29 | 
| Fatigue | Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F) | week 0 | 
| Fatigue | Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F) | week 5 | 
| Fatigue | Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F) | week 17 | 
| Fatigue | Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | week 29 | 
| Adverse Events | Number of patients with adverse events and type of the adverse event | week 5 | 
| Adverse Events | Number of patients with adverse events and type of the adverse event | week 17 | 
| Change in proinflammatory cytokine | Interleukin-6 | week 0 | 
| Change in proinflammatory cytokine | Interleukin-6 | 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. | 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. | 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. | week 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Initiation and Maintenance Disorders, Acupuncture, Ear, Cytokines, Breast Neoplasm