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

Cancer Clinical Trial

— SHUTi-C  

Official title:

Evaluating Internet-Based Interventions for Insomnia in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716872
• Other study ID #: 13685
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: February 24, 2010
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2010
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Insomnia

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Department of Psychiatry & Neurobehavioral Sciences	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)		prior to intervention, after SHUTi use, after Hypnosis use	No
Primary	Sleep Diary: Sleep Efficiency		prior to intervention, after SHUTi use, after Hypnosis use	No
Primary	Sleep Diary: Total Sleep Time		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Sleep Diary: Sleep Onset Latency (SOL)		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Sleep Diary: Wake After Sleep Onset (WASO)		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Sleep Diary: Number of Nighttime Awakenings		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Hospital Depression and Anxiety Scale		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Pain scale		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Multidimensional Fatigue Symptom Inventory		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Quality of Life (SF-12 Health Survey)		prior to intervention, after SHUTi use, after Hypnosis use	No
Secondary	Hot flashes		prior to intervention, after SHUTi use, after Hypnosis use	No