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InsomniaiCANSleepNCT07101302

iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors

A study testing App-Based Cognitive Behavioural Therapy for Insomnia in people with Insomnia and Cancer, run by Memorial University of Newfoundland at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insomnia, Cancer
What is being tested?
App-Based Cognitive Behavioural Therapy for Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteCanada
Study dates
4 Nov 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheila N Garland contact

1 (709) 864-8035

icansleepapp@gmail.com

Canada1 site, 1 recruiting

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3X9

    Sheila N Garland, 1 (709) 864-8035, icansleepapp@gmail.com

    Recruiting

Other trials in Canada

About this study

Official title: iCANSleep: A Randomized Controlled Trial of a Smartphone App-Based Insomnia Treatment for Cancer Survivors

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.

Read the detailed description

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).

Conditions
Insomnia, Cancer
Being tested
App-Based Cognitive Behavioural Therapy for Insomnia
Keywords
Cancer Survivor, Insomnia, Mobile Application
Medical subject headings
Sleep Initiation and Maintenance Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App-Based Cognitive Behavioural Therapy for InsomniaBehavioural

    Also called Cognitive Behavioural Therapy for Insomnia, CBT-I

    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.

Study groups in NCT07101302
Study groupRoleWhat they receive
Immediate TreatmentExperimentalThe immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.
Receives: Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia
Waitlist ControlExperimentalThe waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.
Receives: Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity

    Insomnia Severity Index (Min: 0, Max: 28; Higher scores = worse outcomes)

    Measured: From enrollment until 3-month follow-up

  2. Sleep Efficiency

    Sleep efficiency measured by the Consensus Sleep Diary

    Measured: From enrollment to end of treatment at 7 weeks

  3. Sleep-Onset Latency

    Sleep-onset latency measured by the Consensus Sleep Diary

    Measured: From enrollment to end of treatment at 7 weeks

  4. Wake After Sleep Onset

    Wake after sleep onset measured by the Consensus Sleep Diary

    Measured: From enrollment to end of treatment at 7 weeks

  5. Total Sleep Time

    Total sleep time measured by the Consensys Sleep Diary

    Measured: From enrollment to end of treatment at 7 weeks

Secondary outcomes (13)

  1. Fatigue

    Patient-Reported Outcome Measurement Information System: Fatigue 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  2. Anxiety

    Patient-Reported Outcome Measurement Information System Anxiety 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  3. Depression

    Patient-Reported Outcome Measurement Information System Depression 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  4. Pain Level

    Patient-Reported Outcome Measurement Information System Pain 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  5. Cognitive Function

    Patient-Reported Outcome Measurement Information System Cognitive Function 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  6. Work Productivity and Activity Impairment

    Work Productivity and Activity Impairment (WPAI; Min: 0%, Max: 100%; Higher scores = greater impairment)

    Measured: From enrollment to 3-month follow-up

  7. 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.

    Measured: From time of starting the app to completing treatment (7 weeks)

  8. 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).

    Measured: From enrollment to 3-month follow-up

  9. Sleep-Related Beliefs

    Cancer-related dysfunctional beliefs and attitudes about sleep (C-DBAS-14; Min: 0, Max: 140; Higher scores = more dysfunctional beliefs)

    Measured: From enrollment to 3-month follow-up

  10. Pre-Sleep Arousal

    Pre-sleep arousal scae (PSAS; Min: 16, Max: 80; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  11. Sleep Metrics

    Whole week Self Assessment of sleep survey (SASS)

    Measured: During 8-week waiting period for waitlist control group and from treatment end (7 weeks) to 3-month follow up

  12. Daytime Impact of Insomnia

    Insomnia daytime symptom and impact questionnaire (IDSIQ; Min: 0, Max: 140; Higher scores = worse outcomes)

    Measured: From enrollment to 3-month follow-up

  13. Smartphone Self-Efficacy

    The Smartphone Self-Efficacy Scale (SSES; Min: 19, Max: 95; Higher scores = worse outcomes)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start4 Nov 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07101302
Sponsor's protocol ID
43146
Acronym
iCANSleep
Status last verified
Feb 2026
First submitted
28 Jul 2025
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing App-Based Cognitive Behavioural Therapy for Insomnia in people with Insomnia and Cancer, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheila N Garland (1 (709) 864-8035, icansleepapp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity (time frame: From enrollment until 3-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07101302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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