Clinical trial NCT02272712: The Effectiveness of Online Treatment for Insomnia in Cancer Survivors
Official title: The Effectiveness of Online Treatment for Insomnia in Cancer Survivors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: cancer survivor
computerized treatment
symptom management
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: University of Manitoba
First posted: 2014-10-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Insomnia is a common adverse effect of cancer and its treatment. More than 25% of cancer survivors meet diagnostic criteria, a rate at least two times higher than that of the general population. Despite the pervasiveness of the problem, insomnia is underdiagnosed and undertreated in cancer survivors, resulting in significant suffering and associated consequences such as fatigue, cognitive issues, mood disturbance, functional disability, decreased quality of life, and immunosuppression. Consistent with recent evidence that group cognitive behavioral therapy for insomnia (CBT-I) is effective in treating insomnia in cancer survivors, CBT-I is recommended as first line treatment in the new Pan-Canadian practice guideline for sleep disturbance in adults with cancer. A major barrier to practical application of this recommendation however, is the lack of appropriately trained professionals at cancer centres. Moreover, it is assumed that in contrast to pharmacotherapy, CBT-I is free of treatment-related side-effects; however, we have no knowledge of symptoms that may be experienced by cancer survivors and/or exacerbated during CBT-I treatment (e.g., increased fatigue, cognitive impairment) because such effects are not systematically monitored. With the goal of improved access to CBT-I, online versions have been developed. One initial evaluation has been conducted in cancer patients with promising results, although limitations of the study include a small sample size (n = 28), control condition that failed to match for modality and time, lack of follow-up data, and failure to investigate potential side effects during treatment. Further inquiry is clearly warranted and consistent with insights of Canadian cancer patients who have suggested the use of technology as a factor that would facilitate their participation in an insomnia treatment program.

Specific research questions to be addressed in our proposed two-group, randomized, controlled trial include: 1) Do cancer survivors with chronic insomnia who receive a 6-week, internet-based CBT-I treatment have greater improvement in insomnia severity and other secondary sleep and quality of life outcomes, than participants in an online sleep education control group? 2) Are there short-term side-effects associated with CBT-I for cancer survivors (i.e., do participants get worse before they get better)?

Adult outpatients diagnosed with any type of cancer (stages I-III), completed active treatment for at least 1 month (with the exception of hormone therapy) and without cancer recurrence will be will be recruited from The Ottawa Hospital Cancer Centre and Cancercare Manitoba (n = 150). All will meet established diagnostic and research criteria for chronic insomnia. Prior to acceptance in the study, the procedures will be fully explained, inclusion/exclusion criteria assessed, and formal consent obtained. Once accepted into the study, participants will be randomized (stratified by hormone therapy-yes or no) to one of the two study arms. Online assessment measures (insomnia severity, pre-sleep arousal, beliefs about sleep, fatigue, mood, anxiety, quality of life) will be completed at the baseline period, at week 6 (post treatment), and at 3 month follow-up; however, online diary assessments of sleep parameters and potential side-effects (fatigue, affect, cognition, pain, drug dosing) will be entered daily and potential side-effects will also be assessed online weekly through the course of treatment. Analyses will involve mixed modeling and latent growth curve models.

The computerized intervention evaluated in this study has the potential to bridge an existing gap in knowledge translation by providing cancer survivors widespread access to CBT-I in a cost-effective manner. The study will also investigate potential short-term side-effects of online CBT-I so that patients can be fully informed when making treatment decisions. The online program could serve as the foundation of a stepped care model as recommended in the Pan-Canadian sleep guideline for adults with cancer. Overall, by reducing the burden of residual effects of cancer and its treatments, this research aims to enhance quality of life for cancer survivors in Canada and elsewhere.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Insomnia Severity Index (Morin & Espie, 2003)
timeFrame: October 2016 - October 2019, up to 3 years
Secondary outcomes:
measure: Modified Edmonton Symptom Assessment System-Revised (ESAS-R) (Philip, Smith, Craft, & Lickiss, (1998)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Sleep diary (Carney et al., 2012)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Positive and Negative Affect Schedule (negative subscale)(Watson, Clark & Tellegen, 1988)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Pain Intensity Ratings (Jensen, Turner, Romano, & Fisher, 1999)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Functional Assessment of Cancer Therapy-Cognition scale: Perceived Cognitive Impairment subscale (Wagner et al., 2004)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-10) (Espie, Inglis, Harvey, & Tessier, 2000)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Pre-Sleep Arousal Scale (PSAS) (Nicassio, Mendlowitz, Fussell, & Petras, 1985)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Multi-Dimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke, & de Haes, 1995)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Depression Anxiety Stress Scale - (DASS) (Lovibond & Lovibond, 1995)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Work and Social Adjustment Scale (WSAS) (Mundt, Marks, Shear, & Griest, 2002)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Impact of Event Scale (IES) (Horowitz, Wilner, & Alvarez, 1979)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Assessment of Survivor Concerns (ASC) (Gotay & Pagano, 2007)
timeFrame: October 2016 - October 2019, up to 3 years
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)- Global Quality of Life Subscale (Aaronson, Ahmedzai, & Bergman, 1993; Osoba et al., 1997)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Multi-Dimensional Fatigue Inventory (Smets, Garssen, Bonke, & de Haes, 1995)
timeFrame: October 2016 - October 2019, up to 3 years
measure: Global Adherence Scale
timeFrame: October 2016 - October 2019, up to 3 years
measure: Client Feedback Questionnaire
timeFrame: October 2016 - October 2019, up to 3 years
measure: Client Global Improvement and Overall Change (CGI)(Guy, 1976)
timeFrame: October 2016 - October 2019, up to 3 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Cheryl Harris
role: PRINCIPAL_INVESTIGATOR
References: