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

February 24, 2010 updated by: University of Virginia

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insomnia Severity Index (ISI)
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Efficiency
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Total Sleep Time
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep Diary: Sleep Onset Latency (SOL)
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Wake After Sleep Onset (WASO)
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Number of Nighttime Awakenings
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Hospital Depression and Anxiety Scale
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Pain scale
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Multidimensional Fatigue Symptom Inventory
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Quality of Life (SF-12 Health Survey)
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use
Hot flashes
Time Frame: prior to intervention, after SHUTi use, after Hypnosis use
prior to intervention, after SHUTi use, after Hypnosis use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13685

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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