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

Primary Purpose

Cancer, Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep Healthy Using the Internet (SHUTi)

Hypnosis recordings

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, sleep, insomnia, Internet, SHUTi

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Virginia Department of Psychiatry & Neurobehavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

ImmedSHUTi/ImmedHyp

ImmedSHUTi/DelayHyp

DelaySHUTi/ImmedHyp

DelaySHUTi/DelayHyp

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)

Sleep Diary: Sleep Efficiency

Sleep Diary: Total Sleep Time

Secondary Outcome Measures

Sleep Diary: Sleep Onset Latency (SOL)

Sleep Diary: Wake After Sleep Onset (WASO)

Sleep Diary: Number of Nighttime Awakenings

Hospital Depression and Anxiety Scale

Pain scale

Multidimensional Fatigue Symptom Inventory

Quality of Life (SF-12 Health Survey)

Hot flashes

Full Information

NCT ID

NCT00716872

First Posted

June 18, 2008

Last Updated

February 24, 2010

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT00716872

Brief Title

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

Acronym

SHUTi-C

Official Title

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Virginia

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Insomnia

Keywords

cancer, sleep, insomnia, Internet, SHUTi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ImmedSHUTi/ImmedHyp

Arm Type

Experimental

Arm Description

Arm Title

ImmedSHUTi/DelayHyp

Arm Type

Experimental

Arm Description

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.

Arm Title

DelaySHUTi/ImmedHyp

Arm Type

Experimental

Arm Description

Arm Title

DelaySHUTi/DelayHyp

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sleep Healthy Using the Internet (SHUTi)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Hypnosis recordings

Intervention Description

Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

Time Frame