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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Behavioral: Sleep Healthy Using the Internet (SHUTi)
* Behavioral: Hypnosis recordings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImmedSHUTi/ImmedHyp<br>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)<br>* 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.<br>Behavioral: Hypnosis recordings<br>* Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.<br>|
| Experimental: ImmedSHUTi/DelayHyp<br>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)<br>* 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.<br>|
| Experimental: DelaySHUTi/ImmedHyp<br>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<br>* Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.<br>|
| No Intervention: DelaySHUTi/DelayHyp<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, sleep, insomnia, Internet, SHUTi