Acupuncture for Sleep Disruption in Cancer Survivors

Study Overview
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Brief Summary
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The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment

Official Title
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Acupuncture for Sleep Disruption in Cancer Survivors

Conditions
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Sleep Initiation and Maintenance Disorders, Breast Cancer

Intervention / Treatment
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* Procedure: acupuncture
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females diagnosed with breast cancer who are not currently undergoing cancer treatment (hormonal treatment is permitted). The last cancer treatment ≥ 2 weeks prior to screening. ≥ 21 years of age. Able to understand written and spoken English. Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11 am. Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview of Sleep Disorders) with duration ≥ 1 month by Screening. Willingness to discontinue the use of any current sleep aides (prescription, OTC, or naturopathic agents). Properly executed Informed Consent. Karnofsky Performance Scale Index score ≥ to 70, (patients who score between 61-69 might be included per PI's evaluation). Insomnia Severity Index (ISI) > 8 at Screening. Able to travel to Stanford University and vicinity for assessments and acupuncture treatments. Exclusion Criteria: Unstable medical or psychiatric illness (eMINI, current or within the last 5 years). Exposure to acupuncture within 6 months prior to screening. Currently pregnant or nursing. History of substance abuse or meet criteria for current alcohol abuse or dependence. Center for Epidemiological Studies Depression Scale (CES-D) >27 at Screening. Meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is ≥ to 3. Major surgery within 4 weeks prior to first acupuncture treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture Arm<br> | Procedure: acupuncture<br>* The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected.<br>|
| Sham Comparator: Sham Acupuncture<br>Sham Acupuncture | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue reduction |  | 1 month and 3 months post final acupuncture treatment | 
| Quality of life in breast cancer survivors after acupuncture | Quality of life in breast cancer survivors after acupuncture will be measured through questionnaire using 28 item scale of functional assessment of chronic illness therapy- fatigue subscale (FACIT-F) version 4. Total score ranges from 0 to 108. A higher score indicates better quality of life. | 1 month and 6 months post final acupuncture treatment | 
| Insomnia reduction |  | 1 month and 3 months post final acupuncture treatment |