Medpedia

• Cancer
• Insomnia

Inclusion Criteria:
-  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 Criteria:
-  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

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 (called SHUTi, or "Shut-Eye") as well as to self-hypnosis recordings
designed to improve sleep.  SHUTi provides an online, tailored educational program to
individuals who are experiencing sleep difficulties, including those having difficulty
falling asleep, waking in the middle of the night, and waking too early in the morning.

• Behavioral: Sleep Healthy Using the Internet (SHUTi)
  SHUTi is an Internet program based on cognitive-behavioral therapy for insomnia (CBT-I). Users complete daily online sleep diaries in addition to receiving weekly access to six interactive "Cores" of information. As they progress through the program, users receive tailored instructions for how to improve their sleep.
• Behavioral: Hypnosis recordings
  Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.

• Insomnia Severity Index (ISI)
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Sleep Diary: Sleep Efficiency
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Sleep Diary: Total Sleep Time
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Sleep Diary: Sleep Onset Latency (SOL)
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Sleep Diary: Wake After Sleep Onset (WASO)
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Sleep Diary: Number of Nighttime Awakenings
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Hospital Depression and Anxiety Scale
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Pain scale
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Multidimensional Fatigue Symptom Inventory
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Quality of Life (SF-12 Health Survey)
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No
• Hot flashes
  prior to intervention, after SHUTi use, after Hypnosis use
  Safety Issue: No

• Lee M Ritterband, Ph.D.
  Principal Investigator, University of Virginia
• Lora D Baum, Ph.D.
  Principal Investigator, University of Virginia
• Elaine T Bailey, Ph.D.
  Study Director, University of Virginia

• University of Virginia Department of Psychiatry & Neurobehavioral Sciences
  Charlottesville, Virginia, 22908, United States
  Completed

• University of Virginia
  Lead Sponsor
• United States: Institutional Review Board

• Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96.

• Link to the SHUTi (Sleep Healthy Using the Internet) program
  http://www.shuti.net