Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Breast Diseases

Skin Diseases

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

Ear acupuncture

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

Psychoeducation

Gustav Dobos, Prof. MD

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.

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

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

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.

Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

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.

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.

Number of patients with adverse events and type of the adverse event

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen

Spots Global Cancer Trial Database for acupuncture, ear