Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT07101302
Eligibility Criteria:
Inclusion Criteria:
* Cancer survivors
* Over 18 years of age
* Lives in Canada
* Understands English or French fluently
* DSM-5 diagnosis of insomnia
* ISI score of 8 or higher
* Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
* Access to internet connection
* Ownership of smartphone
* Fluency using mobile applications.
* Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollment (for individuals with non-metastatic cancer) or be on a stable treatment regimen for the prior 3 months (for individuals with metastatic cancer) to ensure that insomnia is not a direct, acute response to cancer treatment.
* Individuals with hematological malignancies must be in remission at the time of recruitment and have completed cancer treatments (e.g., transplant, chemotherapy, immunotherapy, radiotherapy) at least 3 months prior.
Exclusion Criteria:
* Presence of a sleep disorder other than insomnia that is not adequately treated (e.g., untreated sleep apnea)
* Presence of a psychological disorder that is currently untreated or would impair the ability to participate (e.g., bipolar disorder)
* Major sensory deficit (e.g., blindness)
* Previous experience receiving CBT-I.
* The use of medications prescribed for sleep (e.g., hypnotics, sedatives, or antidepressants) will be tracked and adjusted for in the statistical analysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07101302
Study Brief:
Protocol Section:
NCT07101302