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Completed

NCT Number: NCT00716872

Improving the Sleep of Cancer Patients Using an Internet-Based Program

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.

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Key information

Conditions

Cancer Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Department of Psychiatry & Neurobehavioral Sciences

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Healthy Using The Internet (SHUTi)

Behavioral

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.

Hypnosis recordings

Behavioral

Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  2. Sleep Diary: Sleep Efficiency

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  3. Sleep Diary: Total Sleep Time

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

Secondary outcomes

  1. Sleep Diary: Sleep Onset Latency (SOL)

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  2. Sleep Diary: Wake After Sleep Onset (WASO)

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  3. Sleep Diary: Number of Nighttime Awakenings

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  4. Hospital Depression and Anxiety Scale

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  5. Pain scale

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  6. Multidimensional Fatigue Symptom Inventory

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  7. Quality of Life (SF-12 Health Survey)

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

  8. Hot flashes

    Time frame: prior to intervention, after SHUTi use, after Hypnosis use

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Acronym: SHUTi-C

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2008
Registry last updated
Feb 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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