Cancer, Insomnia
Conditions
Keywords
cancer, sleep, insomnia, Internet, SHUTi
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 cancer and experiencing symptoms of insomnia.
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 (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.
Interventions
BEHAVIORALSleep 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.
BEHAVIORALHypnosis recordings
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) | prior to intervention, after SHUTi use, after Hypnosis use |
| Sleep Diary: Sleep Efficiency | prior to intervention, after SHUTi use, after Hypnosis use |
| Sleep Diary: Total Sleep Time | prior to intervention, after SHUTi use, after Hypnosis use |
Secondary
| Measure | Time frame |
|---|---|
| Hospital Depression and Anxiety Scale | prior to intervention, after SHUTi use, after Hypnosis use |
| Pain scale | prior to intervention, after SHUTi use, after Hypnosis use |
| Sleep Diary: Sleep Onset Latency (SOL) | prior to intervention, after SHUTi use, after Hypnosis use |
| Quality of Life (SF-12 Health Survey) | prior to intervention, after SHUTi use, after Hypnosis use |
| Hot flashes | prior to intervention, after SHUTi use, after Hypnosis use |
| Multidimensional Fatigue Symptom Inventory | prior to intervention, after SHUTi use, after Hypnosis use |
| Sleep Diary: Wake After Sleep Onset (WASO) | prior to intervention, after SHUTi use, after Hypnosis use |
| Sleep Diary: Number of Nighttime Awakenings | prior to intervention, after SHUTi use, after Hypnosis use |
Countries
United States
Outcome results
None listed