iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors

NCT07101302 | Recruiting

• 1 other identifier: 43146
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. The investigators will recruit 146 people with insomnia who have completed cancer treatment at least 3 months prior to the study.

Conditions

Insomnia; Cancer

Keywords

Cancer Survivor; Insomnia; Mobile Application

Outcome Measures

Primary Outcomes (5)

• Insomnia Severity

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

  From enrollment until 3-month follow-up

• Sleep Efficiency

  Sleep efficiency measured by the Consensus Sleep Diary

  From enrollment to end of treatment at 7 weeks

• Sleep-Onset Latency

  Sleep-onset latency measured by the Consensus Sleep Diary

  From enrollment to end of treatment at 7 weeks

• Wake After Sleep Onset

  Wake after sleep onset measured by the Consensus Sleep Diary

  From enrollment to end of treatment at 7 weeks

• Total Sleep Time

  Total sleep time measured by the Consensys Sleep Diary

  From enrollment to end of treatment at 7 weeks

Secondary Outcomes (13)

• Fatigue

  From enrollment to 3-month follow-up

• Anxiety

  From enrollment to 3-month follow-up

• Depression

  From enrollment to 3-month follow-up

• Pain Level

  From enrollment to 3-month follow-up

• Cognitive Function

  From enrollment to 3-month follow-up

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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

Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia

Waitlist Control

EXPERIMENTAL

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

Interventions

App-Based Cognitive Behavioural Therapy for Insomnia BEHAVIORAL

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

Immediate Treatment; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

Memorial University of Newfoundland

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

RECRUITING

Related Links

• The official iCANSleep study website

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheila N Garland

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

• Rachel M Lee

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila N Garland

CONTACT

1 (709) 864-8035; icansleepapp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology and Oncology at Memorial University of Newfoundland

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)