Clinical trial NCT00716872: Improving the Sleep of Cancer Patients Using an Internet-Based Program
Official title: Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Keywords: cancer
sleep
insomnia
Internet
SHUTi
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Sleep Diary: Sleep Efficiency
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Sleep Diary: Total Sleep Time
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
Secondary outcomes:
measure: Sleep Diary: Sleep Onset Latency (SOL)
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Sleep Diary: Wake After Sleep Onset (WASO)
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Sleep Diary: Number of Nighttime Awakenings
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Hospital Depression and Anxiety Scale
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Pain scale
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Multidimensional Fatigue Symptom Inventory
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Quality of Life (SF-12 Health Survey)
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
measure: Hot flashes
timeFrame: prior to intervention, after SHUTi use, after Hypnosis use
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Department of Psychiatry & Neurobehavioral Sciences
state: Virginia
Study officials:
affiliation: University of Virginia
name: Lee M Ritterband, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Lora D Baum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Elaine T Bailey, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1200/JCO.2005.09.548.