App-Based Cognitive Behavioural Therapy for Insomnia in Cancer Survivors

(iCANSleep Trial)

Overseen By Sheila N Garland

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial University of Newfoundland

Disqualifiers: Sleep apnea, Untreated bipolar, Sensory deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app for Cognitive Behavioural Therapy for Insomnia (CBT-I) can improve sleep for cancer survivors in Canada. Participants will begin the app-based therapy immediately or after an 8-week waiting period to compare results. This trial suits cancer survivors in Canada who struggle with sleep and completed cancer treatment at least 3 months ago. Participants must have a smartphone and be comfortable using mobile apps. As an unphased trial, this study offers a unique opportunity for participants to potentially enhance their sleep and contribute to research that may benefit other cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications prescribed for sleep, this will be tracked and considered in the study's analysis.

What prior data suggests that this app-based therapy is safe for cancer survivors?

Research has shown that using an app for Cognitive Behavioral Therapy for Insomnia (CBT-I) is a safe and well-accepted treatment for cancer survivors. In studies, most participants did not experience unexpected medical problems during treatment. The app, called iCANSleep, employs a specialized CBT-I method tailored for cancer survivors, helping them manage insomnia with tools like daily sleep diaries. This digital therapy has improved sleep, making it a promising option for those who have completed cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about app-based cognitive behavioral therapy (CBT) for insomnia in cancer survivors because it offers a convenient and accessible way to tackle sleep issues. Unlike traditional CBT, which often requires in-person sessions with a therapist, this app-based approach allows users to receive guidance and support anytime, anywhere, directly on their smartphones. This delivery method could make evidence-based insomnia treatment more widely available, especially for those who may have difficulty accessing healthcare facilities. Additionally, it empowers individuals to manage their sleep problems at their own pace, potentially leading to better adherence and outcomes.

What evidence suggests that app-based cognitive behavioural therapy is effective for insomnia in cancer survivors?

Research has shown that using an app for Cognitive Behavioural Therapy for Insomnia (CBT-I) can improve sleep in cancer survivors. One study found that digital CBT-I significantly reduced insomnia in women with breast cancer. Another study demonstrated that a CBT-I program not only alleviated insomnia but also enhanced mental health and quality of life. In this trial, participants in the immediate treatment arm will begin the app-based insomnia intervention immediately after enrolling, while those in the waitlist control arm will start after an 8-week waiting period. These findings suggest that an app like iCANSleep could effectively manage sleep problems following cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel M Lee

Principal Investigator

Memorial University of Newfoundland

Sheila N Garland

Principal Investigator

Memorial University of Newfoundland

Are You a Good Fit for This Trial?

This trial is for Canadian cancer survivors who finished treatment at least 3 months ago and are now struggling with insomnia. It's not clear what the exclusion criteria are, but typically they might exclude people with certain medical conditions or those using conflicting treatments.

Inclusion Criteria

Cancer survivors

Lives in Canada

I am over 18 years old.

Exclusion Criteria

I have a sleep disorder other than insomnia that is not treated.

Major sensory deficit (e.g., blindness)

I am taking medication for sleep, which will be considered in the study's analysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waiting Period

Participants in the waitlist control group wait for 8 weeks before starting treatment

8 weeks

1 visit (virtual)

Treatment

Participants receive the app-based insomnia intervention for 7 weeks

7 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• App-Based Cognitive Behavioural Therapy for Insomnia

Trial Overview The 'iCANSleep' study tests if a smartphone app delivering Cognitive Behavioural Therapy for Insomnia (CBT-I) helps improve sleep in cancer survivors, compared to those on a waitlist without this intervention.

How Is the Trial Designed?

Group I: Waitlist Control Experimental Treatment 1 Intervention

The waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.

Group II: Immediate Treatment Experimental Treatment 1 Intervention

The immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.

Who Is Running the Clinical Trial?

Memorial University of Newfoundland

Lead Sponsor

Trials

73

Recruited

1,836,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12456873/

Development of a Mobile App (iCANSleep) to Treat Insomnia ... This study aimed to understand the needs and preferences of cancer survivors and test the usability of an evidence-based CBT-I smartphone app ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07101302

iCANSleep: Smartphone App-Based Insomnia Treatment ... 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 ...

3. jmir.org jmir.org/2024/1/e50555/

Multicenter, Single-Blind Randomized Clinical Trial Conclusions: Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time- ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823907

Voice-Activated Cognitive Behavioral Therapy for Insomnia This randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia ...

5. ascopost.com ascopost.com/issues/september-10-2023/there-s-an-app-for-that-digital-health-solutions-for-treating-insomnia-in-cancer-survivors/

Digital Health Solutions for Treating Insomnia in Cancer ... In a sample of 255 women with breast cancer, digital CBT-I produced large effect sizes for reducing insomnia.10. These interventions also hold ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07101302?cond=cancer

iCANSleep: Smartphone App-Based Insomnia Treatment ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia Efficacy of a theory-based cognitive behavioral technique app-based intervention for patients with insomnia: randomized controlled trial.

8. sleep.biomedcentral.com sleep.biomedcentral.com/articles/10.1186/s41606-025-00129-8

Recording and reporting of adverse events during a ... CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be ...

9. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia ...