Improving the Sleep of Cancer Patients Using an Internet-Based Program (SHUTi-C)

University of Virginia

Status: Completed

Conditions: Insomnia; Cancer

Treatments: Behavioral: Hypnosis recordings; Behavioral: Sleep Healthy Using the Internet (SHUTi)

Study type: Interventional

Funder types: Other

Identifiers

NCT00716872

13685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

ImmedSHUTi/ImmedHyp

Experimental group

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.

Treatment:

Behavioral: Sleep Healthy Using the Internet (SHUTi)

Behavioral: Hypnosis recordings

ImmedSHUTi/DelayHyp

Experimental group

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.

Treatment:

Behavioral: Sleep Healthy Using the Internet (SHUTi)

DelaySHUTi/ImmedHyp

Experimental group

Description:

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.

Treatment:

Behavioral: Hypnosis recordings

DelaySHUTi/DelayHyp

No Intervention group

Description:

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.