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

Sponsor

University of Virginia (Other)

Overall Status

Completed

CT.gov ID

NCT00716872

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Insomnia	Behavioral: Sleep Healthy Using the Internet (SHUTi) Behavioral: Hypnosis recordings	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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