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

Breast Neoplasm Clinical Trial

— EOMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874598
• Other study ID #: 18-8214-BO
• Secondary ID: KVC 0/100/2018
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: May 2021
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

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