Clinical trial · Interventional
Improving the Sleep of Cancer Patients Using an Internet-Based Program
Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
NCT00716872CI-TRIAL-00003196SHUTi-CcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnosis recordings | Behavioral | — | UNRESOLVED |
| Sleep Healthy Using the Internet (SHUTi) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ImmedSHUTi/ImmedHyp
- 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.
- interventionNames
- Behavioral: Sleep Healthy Using the Internet (SHUTi)
- Behavioral: Hypnosis recordings
- type
- EXPERIMENTAL
- label
- ImmedSHUTi/DelayHyp
- 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.
- interventionNames
- Behavioral: Sleep Healthy Using the Internet (SHUTi)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDSavard 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. PMID 16135475