The Effectiveness of Online Treatment for Insomnia in Cancer Survivors

NCT02272712 | Completed

• 1 other identifier: 20140224-01H
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general population. The Pan-Canadian sleep guideline for adults with cancer recommends Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems, however, are the lack of available CBT-I at cancer centers and the lack of information about possible side-effects of CBT-I. To address this issue, our study will evaluate the effectiveness and potential short-term side-effects of an online version of CBT-I. It is expected that when compared to cancer survivors who receive an online sleep education program, those who receive online CBT-I will experience improved sleep, mood, and quality of life, as well as reduced anxiety and fatigue.

Conditions

Chronic Insomnia

Keywords

cancer survivor; computerized treatment; symptom management

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (Morin & Espie, 2003)

  A psychometrically sound 7-item self-report measure of perceived sleep impairment. Each item is rated using a five-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28. The ISI was recently validated in a large, heterogeneous sample of cancer patients (Savard, Savard, Simard, \& Ivers, 2005).

  October 2016 - October 2019, up to 3 years

Secondary Outcomes (17)

• Modified Edmonton Symptom Assessment System-Revised (ESAS-R) (Philip, Smith, Craft, & Lickiss, (1998)

  October 2016 - October 2019, up to 3 years

• Sleep diary (Carney et al., 2012)

  October 2016 - October 2019, up to 3 years

• Positive and Negative Affect Schedule (negative subscale)(Watson, Clark & Tellegen, 1988)

  October 2016 - October 2019, up to 3 years

• Pain Intensity Ratings (Jensen, Turner, Romano, & Fisher, 1999)

  October 2016 - October 2019, up to 3 years

• Functional Assessment of Cancer Therapy-Cognition scale: Perceived Cognitive Impairment subscale (Wagner et al., 2004)

  October 2016 - October 2019, up to 3 years

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

A 6-week online cognitive-behavioural treatment for insomnia. Each week focuses on a different topic consistent with the cognitive-behavioural theory of insomnia.

Behavioral: Cognitive Behavioural Therapy

Control Condition

NO INTERVENTION

The online attention matched control arm will provide education about sleep without any focus on the active ingredients that constitute the intervention group.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

psychoeducation about insomnia, relaxation training, sleep restriction, stimulus control, hypnotic tapering under direction of a physician, cognitive therapy, sleep hygiene

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult outpatients with a diagnosis of any type of cancer (stages I-III) as long as active treatment is complete for at least 1 month (with the exception of hormone therapy) and there is no diagnosis of cancer recurrence
• Presence of a) difficulty with initiating or maintaining sleep or early morning awakening ≥ 30 minutes, b) daytime impairment (e.g., reduced concentration, fatigue, irritability), c) persistence of problem for at least 3 months, occurring ≥ 3 nights per week, with d) adequate opportunity for sleep and e) not entirely attributable to a mental or physical health disorder, f) access to high speed internet

You may not qualify if:

• Diagnosis of cancer recurrence
• Presence of symptoms suggestive of acute suicidality, current mania, schizophrenia, or head injury
• Shift work
• Weekly alcohol use in excess of 14 drinks per week for males and 12 drinks per week for females
• Current or previous cognitive behavioral therapy for insomnia
• Non-residents of Ontario

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Cancer Society (CCS): collaborator
• University of Manitoba: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cheryl Harris

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 23, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CA (1)