An interventional study of App-Based Cognitive Behavioural Therapy for Insomnia in Insomnia and Cancer, sponsored by Memorial University of Newfoundland. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Treatment
The investigators will answer the question of whether treating insomnia using the mobile-app-based intervention of Cognitive Behavioural Therapy for Insomnia (CBT-I) for cancer survivors ("iCANSleep") can improve symptoms of insomnia in Canadian cancer survivors compared to a waitlist control group. The investigators will recruit 146 people with insomnia who have completed cancer treatment at least 3 months prior to the study.
The investigators will conduct a randomized controlled trial of immediate treatment with the CBT-I app "iCANSleep" compared to a delayed treatment group with 146 cancer survivors who have completed primary treatment at least 3 months prior and meet DSM diagnostic criteria for insomnia. Participants who are randomized to the immediate treatment group will complete the 7-modules of the CBT-I treatment right away. Those randomized to the delayed treatment group will begin the intervention following an 8-week waiting period. The treatment group will complete assessments at baseline, mid-treatment, post-treatment, and 3-month follow-up. The delayed treatment group will complete an assessment at baseline, halfway through their wait at 4 weeks, and prior to beginning treatment at 8 weeks. They will also complete assessments at mid-treatment, post-treatment and 3-month follow-up. Insomnia severity will be analyzed using the Insomnia Severity Index (ISI) as the primary outcome. Other measures will include fatigue, anxiety, depression, pain, work productivity, sleep beliefs, daytime impact of insomnia, and pre-sleep arousal.
The investigators hypothesize that the immediate treatment group will report significantly greater improvements in insomnia compared to the waitlist control group at post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained at 3-months follow-up (secondary endpoint).
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 146 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.
Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia
The waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.
Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia
The iCANSleep app is based on an established CBT-I protocol. The core features of the iCANSleep app include 1) a modified CBT-I protocol for cancer survivors and 2) daily sleep diaries. Core components of CBT-I treatment to be implemented include sleep restriction, stimulus control, cognitive restructuring, and psychoeducation. These components will be modified into 7-weekly modules.
Also known as: Cognitive Behavioural Therapy for Insomnia, CBT-I
Insomnia Severity
Insomnia Severity Index (Min: 0, Max: 28; Higher scores = worse outcomes)
Time frame: From enrollment until 3-month follow-up
Sleep Efficiency
Sleep efficiency measured by the Consensus Sleep Diary
Time frame: From enrollment to end of treatment at 7 weeks
Sleep-Onset Latency
Sleep-onset latency measured by the Consensus Sleep Diary
Time frame: From enrollment to end of treatment at 7 weeks
Wake After Sleep Onset
Wake after sleep onset measured by the Consensus Sleep Diary
Time frame: From enrollment to end of treatment at 7 weeks
Total Sleep Time
Total sleep time measured by the Consensys Sleep Diary
Time frame: From enrollment to end of treatment at 7 weeks
Fatigue
Patient-Reported Outcome Measurement Information System: Fatigue 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Anxiety
Patient-Reported Outcome Measurement Information System Anxiety 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Depression
Patient-Reported Outcome Measurement Information System Depression 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Pain Level
Patient-Reported Outcome Measurement Information System Pain 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Cognitive Function
Patient-Reported Outcome Measurement Information System Cognitive Function 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Work Productivity and Activity Impairment
Work Productivity and Activity Impairment (WPAI; Min: 0%, Max: 100%; Higher scores = greater impairment)
Time frame: From enrollment to 3-month follow-up
App Engagement
App engagement will be measured based on the number of logins, complete session use (duration of time on the app), number of visits and amount of time on each module, use of the daily sleep journal and engagement with extra resources and support material.
Time frame: From time of starting the app to completing treatment (7 weeks)
Adverse Events
There is no validated method of reporting AEs in trials of CBT-I in cancer populations. As such, we will use the method developed for the Addressing Cancer Treatment-Related Insomnia Online in Atlantic Canada (ACTION) study, based on the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 and the National Cancer Institute, Cancer Therapy Evaluation Program attribution standards. AEs will be assessed using open- and closed-ended questions. This method follows the CONSORT 2022 guidelines for reporting harms to ensure that the: (1) AEs are clearly defined with descriptions of anticipated AEs; (2) Measurement of AEs and methodology are clearly stated, including validation of measures and timing of use; (3) AEs are reported with an attribution to the relationship of the intervention (i.e. is the AE actually related to the intervention?); and (4) Severity of each AE is reported. This measure will be administered at mid-treatment (4 weeks) and post-treatment (8 weeks).
Time frame: From enrollment to 3-month follow-up
Sleep-Related Beliefs
Cancer-related dysfunctional beliefs and attitudes about sleep (C-DBAS-14; Min: 0, Max: 140; Higher scores = more dysfunctional beliefs)
Time frame: From enrollment to 3-month follow-up
Pre-Sleep Arousal
Pre-sleep arousal scae (PSAS; Min: 16, Max: 80; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Sleep Metrics
Whole week Self Assessment of sleep survey (SASS)
Time frame: During 8-week waiting period for waitlist control group and from treatment end (7 weeks) to 3-month follow up
Daytime Impact of Insomnia
Insomnia daytime symptom and impact questionnaire (IDSIQ; Min: 0, Max: 140; Higher scores = worse outcomes)
Time frame: From enrollment to 3-month follow-up
Smartphone Self-Efficacy
The Smartphone Self-Efficacy Scale (SSES; Min: 19, Max: 95; Higher scores = worse outcomes)
Time frame: Baseline
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 12 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Memorial University of Newfoundland