Smartphone CBT‑I app for insomnia in cancer survivors
iCANSleep: A Randomized Controlled Trial of a Smartphone App-Based Insomnia Treatment for Cancer Survivors
NA · Memorial University of Newfoundland · NCT07101302
This project will test whether the iCANSleep smartphone app reduces insomnia symptoms in Canadian adults who have completed cancer treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial University of Newfoundland (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (St. John's, Newfoundland and Labrador) |
| Trial ID | NCT07101302 on ClinicalTrials.gov |
What this trial studies
Researchers will randomize 146 Canadian adult cancer survivors meeting DSM‑5 criteria for insomnia to immediate access to a seven‑module CBT‑I app (iCANSleep) or to an 8‑week waitlist with delayed access. The immediate group completes the modules right away while the delayed group begins after the wait period; both groups complete assessments at baseline, mid‑treatment, post‑treatment, and at 3‑month follow‑up (the delayed group has extra assessments during the wait). The primary outcome is change in Insomnia Severity Index (ISI); secondary measures include fatigue, anxiety, depression, pain, work productivity, sleep beliefs, daytime impact, and pre‑sleep arousal. Eligibility requires adults living in Canada who are fluent in English or French, own a smartphone with internet access, and meet performance and stability/remission criteria to ensure insomnia is not an acute response to treatment.
Who should consider this trial
Good fit: Adults (≥18) living in Canada who are cancer survivors with DSM‑5 insomnia and ISI ≥8, completed or stabilized treatment for at least 3 months, have ECOG 0–2, are fluent in English or French, and own and can use a smartphone with internet.
Not a fit: People currently undergoing active cancer treatment, those without smartphone/internet access or app skills, or those with uncontrolled severe medical or psychiatric conditions or without DSM‑5 insomnia are unlikely to benefit.
Why it matters
Potential benefit: If effective, the app could offer an accessible at‑home CBT‑I option that lowers insomnia severity and related symptoms for cancer survivors.
How similar studies have performed: Therapist‑delivered and digital CBT‑I have previously reduced insomnia, including evidence in cancer survivor populations, so this app builds on established methods rather than being entirely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St. John's, Newfoundland and Labrador
- Memorial University of Newfoundland — St. John's, Newfoundland and Labrador, Canada (RECRUITING)
Study contacts
- Principal investigator: Sheila N Garland — Memorial University of Newfoundland
- Study coordinator: Sheila N Garland
- Email: icansleepapp@gmail.com
- Phone: 1 (709) 864-8035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Cancer, Cancer Survivor, Mobile Application