Rationale and protocol for a randomized waitlist controlled trial of videoconference delivered cognitive behaviour therapy for insomnia (CBT-I) to improve perceived cognitive impairment (PCI) among cancer survivors

Contemp Clin Trials. 2021 Apr:103:106322. doi: 10.1016/j.cct.2021.106322. Epub 2021 Feb 12.


Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this needs to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at baseline, 4 weeks (mid-treatment), 8 weeks (post treatment), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog). Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options.

Keywords: Cancer; Cognitive behaviour therapy; Insomnia; Perceived cognitive impairment; Randomized controlled trial.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cancer Survivors*
  • Cognitive Behavioral Therapy*
  • Cognitive Dysfunction* / etiology
  • Cognitive Dysfunction* / therapy
  • Humans
  • Neoplasms*
  • Randomized Controlled Trials as Topic
  • Sleep Initiation and Maintenance Disorders* / etiology
  • Sleep Initiation and Maintenance Disorders* / therapy
  • Treatment Outcome
  • Videoconferencing

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