Status:
COMPLETED
Improving the Sleep of Cancer Patients Using an Internet-Based Program
Lead Sponsor:
University of Virginia
Conditions:
Cancer
Insomnia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from ...
Detailed Description
The purpose of this study is to test the feasibility of using an Internet program to improve the sleep of cancer patients with insomnia. Participants will receive access to the Internet program (calle...
Eligibility Criteria
Inclusion
- Age = At least 21 years old
- Regular access to the Internet, including e-mail
- Cancer patient
- Any type of cancer (EXCEPT non-melanoma skin cancer)
- In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)
- Insomnia diagnosis (combined from DSM-IV and ICSD):
- Subjective complaints of poor sleep for at least 6 months
- Sleep difficulties ≥3 nights/week
- Difficulty falling asleep (≥30 minutes to fall asleep) OR
- Difficulty staying asleep (≥30 minutes awake in the middle of the night)
- ≤6.5 hours sleep/night
- Poor sleep causes marked distress or significant impairment in daytime functioning (e.g. fatigue, performance deficits, mood disturbance)
- Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment
Exclusion
- Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)
- Having a medical condition other than cancer that causes insomnia
- Experiencing a psychiatric disturbance (major depression, psychosis)
- Experiencing substance abuse
- Currently undergoing psychotherapy or counseling
- Changing sleep/anxiety/depression medication within the past month
- Having an "unusual" sleep pattern
- Normal bedtime is after 2am OR
- Normal wake time is after 9am
- Working as a shift worker (that is, having a schedule that requires working through the night)
- Participants reports that she is pregnant or intending to get pregnant in the next 4 months
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00716872
Start Date
July 1 2008
End Date
November 1 2009
Last Update
February 25 2010
Active Locations (1)
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1
University of Virginia Department of Psychiatry & Neurobehavioral Sciences
Charlottesville, Virginia, United States, 22908