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

Not Applicable

Completed

• Conditions: Cancer; Insomnia
• Interventions: Behavioral: Sleep Healthy Using the Internet (SHUTi); Behavioral: Hypnosis recordings

• Registration Number: NCT00716872
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2008-06-18
• Study Start: 2008-07
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ImmedSHUTi/ImmedHyp	Sleep Healthy Using the Internet (SHUTi)	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.
ImmedSHUTi/ImmedHyp	Hypnosis recordings	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.
ImmedSHUTi/DelayHyp	Sleep Healthy Using the Internet (SHUTi)	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.
DelaySHUTi/ImmedHyp	Hypnosis recordings	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sleep Diary: Sleep Onset Latency (SOL)	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
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
Multidimensional Fatigue Symptom Inventory	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

Trial Locations

Locations (1)

University of Virginia Department of Psychiatry & Neurobehavioral Sciences; 🇺🇸 Charlottesville, Virginia, United States