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Improving the Sleep of Cancer Patients Using an Internet-Based Program (SHUTi-C)

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00716872
First received: June 18, 2008
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Cancer
Insomnia
 Behavioral: Sleep Healthy Using the Internet (SHUTi)
Behavioral: Hypnosis recordings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Sleep Diary: Sleep Efficiency [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Sleep Diary: Total Sleep Time [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Diary: Sleep Onset Latency (SOL) [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Sleep Diary: Wake After Sleep Onset (WASO) [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Sleep Diary: Number of Nighttime Awakenings [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Hospital Depression and Anxiety Scale [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Pain scale [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Multidimensional Fatigue Symptom Inventory [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Quality of Life (SF-12 Health Survey) [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]
  • Hot flashes [ Time Frame: prior to intervention, after SHUTi use, after Hypnosis use ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ImmedSHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away. In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
 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.
Experimental: ImmedSHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Immediate SHUTi group; that is, they receive access to the SHUTi program right away. In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.
 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.
Experimental: DelaySHUTi/ImmedHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study. In the second part of the trial (3 months later), participants are assigned to the Immediate Hypnosis group; that is, they receive access to the Hypnosis recordings right away.
 Behavioral: Hypnosis recordings
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
No Intervention: DelaySHUTi/DelayHyp
In the first part of the trial, participants are assigned to the Delayed SHUTi group; that is, they receive access to the SHUTi program at the end of the study. In the second part of the trial (3 months later), participants are assigned to the Delayed Hypnosis group; that is, they receive access to the Hypnosis recordings at the end of the study.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716872

Locations
United States, Virginia
University of Virginia Department of Psychiatry & Neurobehavioral Sciences
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Lee M Ritterband, Ph.D. University of Virginia
Principal Investigator: Lora D Baum, Ph.D. University of Virginia
Study Director: Elaine T Bailey, Ph.D. University of Virginia
  More Information

Additional Information:
Link to the SHUTi (Sleep Healthy Using the Internet) program  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Lee Ritterband, Ph.D., University of Virginia
ClinicalTrials.gov Identifier: NCT00716872     History of Changes
Other Study ID Numbers: 13685
Study First Received: June 18, 2008
Last Updated: February 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
cancer
sleep
insomnia
Internet
SHUTi

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013