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Completed

NCT Number: NCT03874598

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

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.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Dyssomnias Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ear acupuncture

Procedure

Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Psychoeducation

Behavioral

Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Official study title

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

Acronym: EOMI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2019
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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