The Effectiveness of Online Treatment for Insomnia in Cancer Survivors

Titre officiel

The Effectiveness of Online Treatment for Insomnia in Cancer Survivors: A Randomized Controlled Trial

Sommaire:

L’insomnie chronique touche plus de 25 % des survivants du cancer, un taux deux fois plus élevé que dans l’ensemble de la population. La ligne directrice pancanadienne sur le sommeil recommande la thérapie cognitivo-comportementale de l’insomnie (TCC-I) comme le meilleur traitement chez les adultes atteints de cancer. Les principaux problèmes, cependant, sont l’indisponibilité de la TCC-I dans les centres anticancéreux et le manque d’information sur les effets secondaires possibles de la TCC-I. Pour résoudre ce problème, notre étude évaluera l’efficacité et les effets secondaires potentiels à court terme d’une version en ligne de la TCC-I. On s’attend à ce que, par rapport aux survivants du cancer qui reçoivent un programme en ligne de sensibilisation au sommeil, ceux qui reçoivent une TCC-I en ligne présentent une amélioration du sommeil, de l’humeur et de la qualité de vie, ainsi qu’une diminution de l’anxiété et de la fatigue.

Description de l'essai

Primary Outcome:

  • Insomnia Severity Index (Morin & Espie, 2003)
Secondary Outcome:
  • Modified Edmonton Symptom Assessment System-Revised (ESAS-R) (Philip, Smith, Craft, & Lickiss, (1998)
  • Sleep diary (Carney et al., 2012)
  • Positive and Negative Affect Schedule (negative subscale)(Watson, Clark & Tellegen, 1988)
  • Pain Intensity Ratings (Jensen, Turner, Romano, & Fisher, 1999)
  • Functional Assessment of Cancer Therapy-Cognition scale: Perceived Cognitive Impairment subscale (Wagner et al., 2004)
  • Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-10) (Espie, Inglis, Harvey, & Tessier, 2000)
  • Pre-Sleep Arousal Scale (PSAS) (Nicassio, Mendlowitz, Fussell, & Petras, 1985)
  • Multi-Dimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke, & de Haes, 1995)
  • Depression Anxiety Stress Scale - (DASS) (Lovibond & Lovibond, 1995)
  • Work and Social Adjustment Scale (WSAS) (Mundt, Marks, Shear, & Griest, 2002)
  • Impact of Event Scale (IES) (Horowitz, Wilner, & Alvarez, 1979)
  • Assessment of Survivor Concerns (ASC) (Gotay & Pagano, 2007)
  • 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)
  • Multi-Dimensional Fatigue Inventory (Smets, Garssen, Bonke, & de Haes, 1995)
  • Global Adherence Scale
  • Client Feedback Questionnaire
  • Client Global Improvement and Overall Change (CGI)(Guy, 1976)
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 behavioural 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.

Voir cet essai sur ClinicalTrials.gov

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