Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index (ISI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Sleep Diary: Sleep Onset Latency (SOL)(prior to intervention, after SHUTi use, after Hypnosis use)
- Sleep Diary: Wake After Sleep Onset (WASO)(prior to intervention, after SHUTi use, after Hypnosis use)
- Sleep Diary: Number of Nighttime Awakenings(prior to intervention, after SHUTi use, after Hypnosis use)
- Hospital Depression and Anxiety Scale(prior to intervention, after SHUTi use, after Hypnosis use)
- Pain scale(prior to intervention, after SHUTi use, after Hypnosis use)
- Multidimensional Fatigue Symptom Inventory(prior to intervention, after SHUTi use, after Hypnosis use)
- Quality of Life (SF-12 Health Survey)(prior to intervention, after SHUTi use, after Hypnosis use)
- Hot flashes(prior to intervention, after SHUTi use, after Hypnosis use)