Acupuncture for Sleep Disruption in Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Insomnia Sleep Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | February 2011 |
| End Date: | August 2012 |
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
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
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.
We found this trial at
1
site
Stanford University School of Medicine Vast in both its physical scale and its impact on...
Click here to add this to my saved trials
