CancerSHUTi-CNCT00716872
Improving the Sleep of Cancer Patients Using an Internet-Based Program
A study testing Sleep Healthy Using the Internet (SHUTi) and Hypnosis recordings in people with Cancer and Insomnia, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Sleep Healthy Using the Internet (SHUTi) and Hypnosis recordings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Department of Psychiatry & Neurobehavioral Sciences
Charlottesville, Virginia, 22908
About this study
Official title: Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
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.
Read the 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.
- Being tested
- Sleep Healthy Using the Internet (SHUTi), Hypnosis recordings
- Keywords
- cancer, sleep, insomnia, Internet, SHUTi
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Healthy Using the Internet (SHUTi)Behavioural
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 recordingsBehavioural
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
| Study group | Role | What they receive |
|---|---|---|
| ImmedSHUTi/ImmedHyp | Experimental | 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. Receives: Behavioral: Sleep Healthy Using the Internet (SHUTi); Behavioral: Hypnosis recordings |
| ImmedSHUTi/DelayHyp | Experimental | 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. Receives: Behavioral: Sleep Healthy Using the Internet (SHUTi) |
| DelaySHUTi/ImmedHyp | Experimental | 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. Receives: Behavioral: Hypnosis recordings |
| DelaySHUTi/DelayHyp | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Efficiency
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Total Sleep Time
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Secondary outcomes (8)
Sleep Diary: Sleep Onset Latency (SOL)
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Wake After Sleep Onset (WASO)
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Number of Nighttime Awakenings
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Hospital Depression and Anxiety Scale
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Pain scale
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Multidimensional Fatigue Symptom Inventory
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Quality of Life (SF-12 Health Survey)
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Hot flashes
Measured: prior to intervention, after SHUTi use, after Hypnosis use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Lee M Ritterband, Ph.D., Principal investigator, University of VirginiaLora D Baum, Ph.D., Principal investigator, University of VirginiaElaine T Bailey, Ph.D., Study director, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716872
- Sponsor's protocol ID
- 13685
- Acronym
- SHUTi-C
- Status last verified
- Feb 2010
- First submitted
- 18 Jun 2008
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1200/JCO.2005.09.548.
PubMed 16135475
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
- ClinicalTrials.gov ID
- NCT00716872
- Acronym / sponsor ID
- SHUTi-C / 13685
- Keywords
- cancer, sleep, insomnia, Internet, SHUTi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ImmedSHUTi/ImmedHyp | Experimental | Behavioral: Sleep Healthy Using the Internet (SHUTi), Behavioral: Hypnosis recordingsIn 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 | Experimental | Behavioral: 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 | Experimental | Behavioral: Hypnosis recordingsIn 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. |
| DelaySHUTi/DelayHyp | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age = At least 21 years old
- Regular access to the Internet, including e-mail
- Cancer patient
- Insomnia diagnosis (combined from DSM-IV and ICSD):
- Difficulty falling asleep (≥30 minutes to fall asleep) OR
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ImmedSHUTi/DelayHyp, ImmedSHUTi/ImmedHyp |
| Hypnosis recordingsSubjects listen to self-hypnosis recordings designed to improve their disturbed sleep. | Behavioural | DelaySHUTi/ImmedHyp, ImmedSHUTi/ImmedHyp |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Efficiency
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Total Sleep Time
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
8 secondary outcomes
Sleep Diary: Sleep Onset Latency (SOL)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Wake After Sleep Onset (WASO)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Number of Nighttime Awakenings
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Hospital Depression and Anxiety Scale
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Pain scale
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Multidimensional Fatigue Symptom Inventory
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Quality of Life (SF-12 Health Survey)
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Hot flashes
Time frame: prior to intervention, after SHUTi use, after Hypnosis use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Background: PubMed 16135475Savard 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. doi: 10.1200/JCO.2005.09.548.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee M Ritterband, Ph.D. principal investigator
University of Virginia
Lora D Baum, Ph.D. principal investigator
University of Virginia
Elaine T Bailey, Ph.D. study director
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Healthy Using the Internet (SHUTi) and Hypnosis recordings in people with Cancer and Insomnia, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: prior to intervention, after SHUTi use, after Hypnosis use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00716872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2010.