Improving the Sleep of Cancer Patients Using an Internet-Based Program (SHUTi-C)
24. februar 2010 opdateret af: University of Virginia
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
22
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Department of Psychiatry & Neurobehavioral Sciences
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
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Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
Subjects listen to self-hypnosis recordings designed to improve their disturbed sleep.
|
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Insomnia Severity Index (ISI)
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Sleep Efficiency
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Total Sleep Time
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sleep Diary: Sleep Onset Latency (SOL)
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Wake After Sleep Onset (WASO)
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Sleep Diary: Number of Nighttime Awakenings
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Hospital Depression and Anxiety Scale
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Pain scale
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Multidimensional Fatigue Symptom Inventory
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Quality of Life (SF-12 Health Survey)
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Hot flashes
Tidsramme: prior to intervention, after SHUTi use, after Hypnosis use
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prior to intervention, after SHUTi use, after Hypnosis use
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lee M Ritterband, Ph.D., University of Virginia
- Ledende efterforsker: Lora D Baum, Ph.D., University of Virginia
- Studieleder: Elaine T Bailey, Ph.D., University of Virginia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2008
Primær færdiggørelse (Faktiske)
1. november 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
18. juni 2008
Først indsendt, der opfyldte QC-kriterier
14. juli 2008
Først opslået (Skøn)
16. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. februar 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. februar 2010
Sidst verificeret
1. februar 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13685
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .