Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

Launched by MEMORIAL UNIVERSITY OF NEWFOUNDLAND · Jul 16, 2019

Keywords

ClinConnect Summary

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 Ass...

Gender

ALL

Eligibility criteria

• Inclusion Criteria for individuals with non-hematological malignancies:
• • Men and women who are easily able to understand and read English
• • No current evidence of cancer or clinically stable/inactive disease
• • Received and completed all adjuvant treatments at least 6 months prior to study entry to allow for neural stabilization and recovery
• • Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
• • Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index (ISI)
• • Have good performance status as indicated by an Eastern Cooperative Oncology Group (ECOG) score of 0-2
• • Have high-speed internet connection, webcam, and are fluent using the internet
• Inclusion Criteria for individuals with hematological malignancies:
• • Men and women who are easily able to understand and read English
• • A diagnosis of a hematological malignancy currently in remission
• • Completed cancer treatments including transplant, chemotherapy and/or immunotherapy at least 6 months prior to study entry
• • Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
• • Meet the DSM-5 criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index
• • Have good performance status as indicated by an ECOG score of 0-2
• • Have high-speed internet connection, webcam, and are fluent using the internet
• Exclusion Criteria for individuals with and without hematological malignancies:
• • Another sleep disorder, besides insomnia, that is not adequately treated (ie: untreated obstructive sleep apnea)
• • The presence of another psychological disorder that is not currently stable and/or would impair the ability to participate in the study
• • A major sensory deficit (e.g. blindness)
• • A neurologic or major medical condition known to affect cognitive function (e.g., Parkinson's)
• • A history of cranial radiation
• • A history of any other condition that may affect cognitive functioning (e.g., traumatic brain injury)
• • Previous experience with CBT-I
• Other considerations:
• • Participants will not be excluded for using psychotropic medication prior to study entry (e.g. antidepressants) provided that the dose was not recently altered (stable over the previous 6 weeks)
• • Considering the potential for prescription of medications to help with sleep (e.g. hypnotics, sedatives, and antidepressants) within the cancer population, medication use throughout the study will be tracked and adjusted for in the statistical analysis