NCT04026048

Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Memorial University of Newfoundland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will answer the question of whether treating insomnia using Cognitive Behavior Therapy for Insomnia (CBT-I) can improve perceived cognitive impairment (PCI) in cancer survivors compared to a waitlist control group. The investigators will recruit 124 people with insomnia and cognitive complaints who have completed cancer treatment at least 6 months prior to the study.

Detailed description

The investigators will conduct a randomized controlled trial of immediate treatment with CBT-I compared to a delayed treatment group with 124 cancer survivors who have completed primary treatment at least 6 months prior and report PCI and insomnia. Participants who are randomized to the immediate treatment group will receive CBT-I over the course of seven weekly one hour sessions, after which the delayed treatment group will receive the intervention. Both groups will complete follow up assessments three and six months after completing treatment. PCI will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) as the primary outcome. To provide an objective assessment of cognition, the investigators have included the neurocognitive measures recommended by the International Cognition and Cancer Task Force. Other measures will include fatigue, anxiety, depression, and work productivity. The investigators hypothesize that the online CBT-I group will report significantly greater improvements in perceived cognitive function compared to the waitlist control immediately post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained up at 6-months follow up (secondary endpoint).

Conditions

• Cancer
• Insomnia
• Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behaviour Therapy for Insomnia (CBT-I)	CBT-I is a manualized multi-component intervention that includes sleep restriction, stimulus control, cognitive restructuring, relaxation training, and sleep hygiene.

Timeline

• Start date: 2019-09-01
• Primary completion: 2023-01-01
• Completion: 2023-06-30
• First posted: 2019-07-19
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

1 site across 1 country: Canada