Breast Neoplasm
Conditions
Keywords
Sleep Initiation and Maintenance Disorders, Acupuncture, Ear, Cytokines, Breast Neoplasm
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.
Interventions
PROCEDUREEar acupuncture
Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.
BEHAVIORALPsychoeducation
Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
Sponsors
Karl and Veronica Carstens Foundation
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | week 0 | Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F) |
| Psychological well-being | 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. |
| Stress | 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. |
| Quality of Life in cancer patients | week 0 | Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B) |
| Change in proinflammatory cytokine | week 0 | Interleukin-6 |
| Expectation | 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. |
| Sleep Quality | 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. |
| Adverse Events | week 5 | Number of patients with adverse events and type of the adverse event |
Countries
Germany
Outcome results
None listed