Breast cancer-related insomnia
Conditions
Interventions
Treatment Group:Intradermal acupuncture
Control Group:Sham intradermal acupuncture
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (?) females aged =18 with a diagnosis of breast cancer; (?)Insomnia symptoms (difficulty falling asleep and/or maintaining sleep): Duration >4 weeks and occurring at least 3 times per week, with the fulfilment of the diagnostic criteria for insomnia disorder in cancer patients published by the National Comprehensive Cancer Network (NCCN); the severity of insomnia reached at least 10 points of Insomnia Severity Index (ISI) over the past 2 weeks; (?) Expected survival =6 months; (?)Eastern Cooperative Oncology Group (ECOG) Performance Status=1; and (?) Voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients undergoing surgery, chemotherapy, radiation, or reconstructive plastic surgery during the study period; (2) Advanced breast cancer patients with evidence of recurrence or metastasis; (3) Patients with serious diseases of cardiovascular and cerebrovascular, liver, kidney, hematopoietic system and serious mental diseases; (4) Pregnant, lactating or pregnant patients; (5) Patients who are allergic to stainless steel or have skin infections or ulcers in the acupoint area; (6) Patients currently receiving acupuncture treatment; (7) Have mental or intellectual disabilities, can not self-judge sleep status, can not independently complete the scale; (8)Participating in other clinical trials of behavioral, psychological, pharmaceutical or complementary medicine interventions; (9) Irregular use of barbiturates, antidepressants or other sleep AIDS (including Chinese medicine); (10) Addiction to caffeine, alcohol or psychotropic drugs; (11) Patients with insomnia whose total sleep duration is less than 4h.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Diary;the Pittsburgh Sleep Quality Index;the Hospital Anxiety and Depression Scale;Brief Fatigue Inventory;the Patient-Reported Outcomes Measurement Information System Global Health Scale; | — |
Countries
China
Contacts
Public ContactBo Chen;Bin Wang
Tianjin University of Traditional Chinese Medicine / Tianjin Cancer Hospital
Outcome results
None listed